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Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
3% PVM/MA + 5% KNO3 Combination
3% PVM/MA only
5% KNO3 Only
Regular Fluoride
Sponsored by
HALEON
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provision of a signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any study procedures are performed.
  • Participant who is willing and able to comply with scheduled visits, product usage requirements and other study procedures.
  • Participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history, or upon oral examination, that would impact the participant's safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
  • Female participant of child-bearing potential and at risk for pregnancy who agrees to use a highly effective method of contraception throughout the study and for at least 5 days after the last use of assigned study product.
  • AT VISIT 1 (Screening):

Participant must have

  1. a self-reported history of tooth sensitivity lasting more than six months but not more than 10 years.
  2. a minimum of 20 natural teeth.

  3. a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH; each tooth must meet the following criteria:

    • exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
    • MGI score = 0 adjacent to the test area (exposed dentine) only (Lobene et al.,1986)
    • clinical mobility = 0 (Laster et al., 1975)
    • Dentin Hypersensitivity (DH) as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to <= 20 gram (g); Schiff sensitivity score greater than or equal to >= 2).
    • AT VISIT 2 (Baseline):

Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre molars) with DH, as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to <= 20 g; Schiff sensitivity score >= 2) at the Screening and Baseline visits.

Note: All teeth which meet the eligibility criteria at Screening (Visit 1) should be assessed by tactile and evaporative (air) stimuli at Baseline (Visit 2).

The examiner will select two 'test teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both Screening and Baseline. Test teeth should not be adjacent to each other and preferably in different quadrants.

Exclusion Criteria:

  • Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family.
  • Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of study entry and/or during study participation.
  • Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • Female participant who is pregnant (as evidenced by a positive urine pregnancy test (UPT) at Screening) or intending to become pregnant during the study.
  • Female participant who is breastfeeding.
  • Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
  • Participant who is unwilling or unable to comply with the Lifestyle Considerations.
  • Participant with a recent history (within the last year) of alcohol or other substance abuse.
  • Participant who has participated in another tooth sensitivity study within 8 weeks of Screening.
  • Participant who has used an oral care product indicated for the relief of DH or care of sensitive teeth within 8 weeks of Screening (participants will be required to verbally confirm the name of their current oral care products to enable site staff to verify the absence of known sensitivity ingredients).
  • Participant who has had dental prophylaxis within 4 weeks of Screening.
  • Participant who has had a teeth bleaching procedure within 8 weeks of Screening.
  • Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening.
  • Participant who has had scaling or root planning within 3 months of Screening.
  • Participant with gross periodontal disease.
  • Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
  • Participant with a tongue or lip piercing.
  • Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator, would impact study outcomes.
  • Participant with multiple dental implants which, in the opinion of the investigator, would impact study outcomes.
  • Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.

  • SPECIFIC DENTITION EXCLUSIONS FOR 'TEST TEETH':

    1. Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening.
    2. Tooth with exposed dentine but with deep, defective or facial restorations.
    3. Tooth with full crown or veneer.
    4. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator, would impact study outcomes.
    5. Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentine.
    6. Sensitive tooth not expected to benefit from use of a sensitivity toothpaste in the opinion of the investigator
  • Participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, antidepressants, mood-altering and anti-inflammatory drugs).
  • AT VISIT 1 (Screening):

Participant who has taken antibiotics in the 2 weeks prior to the Screening visit.

- AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the Baseline visit, during the acclimatisation period.

  • Participant who is taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
  • Participant who requires antibiotic prophylaxis for dental procedures.
  • Participant who has previously been enrolled in this study.
  • Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Sites / Locations

  • Bristol Dental School, University of Bristol

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Other

Arm Label

Test Product

Comparator 1

Comparator 2

Negative Control

Arm Description

Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product is a combination toothpaste of 3% methyl vinyl ether/maleic anhydride co-polymer (PVM/MA) + 5% Potassium Nitrate (KNO3). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); Participants will be permitted to rinse with water post-brushing.

Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 toothpaste is containing 3% PVM/MA. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.

Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 toothpaste is containing 5% KNO3. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.

Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control is regular fluoride toothpaste. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.

Outcomes

Primary Outcome Measures

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 millimeter (mm) coronal to gingival margin from a distance of approximately 1 centimeter(cm). Participant response to the stimulus will be evaluated using the Schiff sensitivity scale,an examiner-based index scored immediately following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus,considers stimulus to be painful,requests discontinuation of the stimulus.Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement.Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to the gingival margin from a distance of approximately 1 cm. Participant response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to the gingival margin from a distance of approximately 1 cm. Participant response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to the gingival margin from a distance of approximately 1 cm. Participant response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to the gingival margin from a distance of approximately 1 cm. Participant response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)
Number of eligible teeth will be identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.

Secondary Outcome Measures

Change From Baseline in Schiff Sensitivity Score at Day 3, 14, 28, 56
Evaporative air sensitivity will be assessed on the facial surfaces of teeth by directing 1 second application of air from dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin and from distance of approximately 1 cm. Participant response to stimulus will be evaluated using Schiff sensitivity scale following administration of evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates improvement. Adjusted mean change from baseline will be derived from analysis of covariance (ANCOVA) model which included treatment as a factor and baseline Schiff sensitivity score as a covariate with change from baseline as dependent variable.
Change From Baseline in Tactile Threshold at Day 3, 14, 28, 56
Tactile sensitivity will be assessed for eligible teeth using constant pressure probe (Yeaple probe). The probe tip will be placed perpendicular to facial surface of tooth and drawn slowly across exposed dentine. After each application, participant will be asked whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gives two consecutives 'yes' responses will be recorded as the tactile threshold (g). At Baseline, the maximum force will be 20g; at all subsequent visits,80g. If no sensitivity will be found at the upper limit, the tactile threshold will be recorded as >20 g (Baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement. Adjusted mean change from baseline will be derived from ANCOVA model which included treatment as factor and baseline tactile sensitivity as covariate with change from baseline as dependent variable.
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Day 3, 14, 28, 56
All participants will score question No. 7 to 9 ([Q7: On a scale of 1 to 10 how intense are the sensations?] section 1 of DHEQ on a scale of 1 to 10, where 1=not at all intense and 10=Worst imaginable, [Q8: On a scale of 1 to 10 how bothered are you by any sensations?] section 1 of DHEQ on a scale of 1 to 10, where 1=not at all bothered and 10=Extremely bothered, [Q 9: On a scale of 1 to 10 how well you can tolerate the sensations?] section 1 of DHEQ on a scale of 1 to 10, where 1=Can easily tolerate and 10=Can't tolerate at all). Section 1 asks questions about participant's sensitive teeth and the impact it has on participant's everyday life.
Change From Baseline in Mean Score of DHEQ Total Score (Section 2 Question 1-15) at Day 3, 14, 28, 56
All participants will score 15 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 is having questions about the ways in which the sensations in the teeth affected participants in daily life. Total score will be derived from the sum of scores in single domains: Restrictions (Section 2, Q1-3), Adaptation (Section 2, Q4-6), Social Impact (Section 2, Q7 to 9), Emotional Impact (Section 2, Q10 to 12), and Identity (Section 2, Q13 to 15).
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (Section 2 Questions 1 to 3)
All participants will score 3 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: It takes a long time to finish some foods and drinks because of sensations, and Q3: There have been times when I have had problems eating ice cream because if these sensations.
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (Section 2 Questions 4 to 6)
All participants will score 3 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q4: I have to change the way I eat or drink certain things, Q5: I have to be careful how I breathe on a cold day, Q6: When eating some foods I have made sure they don't touch certain teeth.
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (Section 2 Questions 7 to 9)
All participants will score 3 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q7: Because of sensations I take longer than others to finish meal, Q8: I have to be careful what I eat when I am with others because of sensation in my teeth, Q9: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (Section 2 Questions 10 to 12)
All participants will score 8 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q10: I have been anxious that something I eat or drink might cause sensations in my teeth, Q11: The sensations in my teeth have been irritating, Q12: The sensations in my teeth have been annoying.
Change From Baseline in Mean DHEQ Score of Domain - Identity (Section 2 Questions 13 to 15)
All participants will score 3 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q13: Having these sensations in my teeth makes me feel old, Q14: Having these sensations in my teeth makes me feel damaged, Q15: Having these sensations in my teeth makes me feel as though I am unhealthy.
Mean Numeric Rating Scale (NRS) Score at Baseline, Day 3, 14, 28, 56
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a participant selects the number (0-10) that best reflects the intensity of the discomfort caused by their sensitivity. Where 0 = no discomfort and 10 = worst discomfort imaginable.
Change From Baseline in Mean NRS Score at Day 3, 14, 28, 56
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a participant selects the number (0-10) that best reflects the intensity of the discomfort caused by their sensitivity. Where 0 = no discomfort and 10 = worst discomfort imaginable.

Full Information

First Posted
February 8, 2022
Last Updated
October 14, 2022
Sponsor
HALEON
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1. Study Identification

Unique Protocol Identification Number
NCT05243745
Brief Title
Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth
Official Title
An 8-week, Randomised, Controlled, Examiner-Blind, Proof of Principle Study Investigating the Ability of a 3% Methyl Vinyl Ether/Maleic Anhydride Co-Polymer (PVM/MA) + 5% Potassium Nitrate (KNO3) Combination Toothpaste to Protect From Dentine Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
October 3, 2022 (Actual)
Study Completion Date
October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HALEON

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This proof of principle (PoP) study will evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity.
Detailed Description
This will be a PoP, single centre, 8-week, randomised, controlled, examiner blind, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth) clinical study in healthy participants with sensitive teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Product
Arm Type
Experimental
Arm Description
Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product is a combination toothpaste of 3% methyl vinyl ether/maleic anhydride co-polymer (PVM/MA) + 5% Potassium Nitrate (KNO3). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); Participants will be permitted to rinse with water post-brushing.
Arm Title
Comparator 1
Arm Type
Active Comparator
Arm Description
Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 toothpaste is containing 3% PVM/MA. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.
Arm Title
Comparator 2
Arm Type
Active Comparator
Arm Description
Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 toothpaste is containing 5% KNO3. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.
Arm Title
Negative Control
Arm Type
Other
Arm Description
Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control is regular fluoride toothpaste. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.
Intervention Type
Other
Intervention Name(s)
3% PVM/MA + 5% KNO3 Combination
Intervention Description
Toothpaste containing 3% PVM/MA + 5% KNO3 as combination will be used as test product.
Intervention Type
Other
Intervention Name(s)
3% PVM/MA only
Intervention Description
Toothpaste containing 3% PVM/MA only will be used as comparator 1 product.
Intervention Type
Other
Intervention Name(s)
5% KNO3 Only
Intervention Description
Toothpastes containing 5% KNO3 only will be used as comparator 2 product.
Intervention Type
Other
Intervention Name(s)
Regular Fluoride
Intervention Description
Toothpaste containing regular fluoride will be used as negative control.
Primary Outcome Measure Information:
Title
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Description
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 millimeter (mm) coronal to gingival margin from a distance of approximately 1 centimeter(cm). Participant response to the stimulus will be evaluated using the Schiff sensitivity scale,an examiner-based index scored immediately following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus,considers stimulus to be painful,requests discontinuation of the stimulus.Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement.Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Baseline (Day 0)
Title
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
Description
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to the gingival margin from a distance of approximately 1 cm. Participant response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Day 3
Title
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
Description
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to the gingival margin from a distance of approximately 1 cm. Participant response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Day 14
Title
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
Description
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to the gingival margin from a distance of approximately 1 cm. Participant response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Day 28
Title
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
Description
Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to the gingival margin from a distance of approximately 1 cm. Participant response to the stimulus will be evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Day 56
Title
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
Description
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Baseline (Day 0)
Title
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
Description
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Day 3
Title
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
Description
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Day 14
Title
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
Description
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Day 28
Title
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
Description
Tactile sensitivity will be assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe).The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses will be recorded as the tactile threshold (g).At Baseline, the maximum force will be 20 g;at all subsequent visits, 80 g.If no sensitivity will be found at the upper limit, the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Mean will be calculated once by selecting two test teeth which are located in different quadrants of mouth.
Time Frame
Day 56
Title
Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)
Description
Number of eligible teeth will be identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame
Baseline (Day 0)
Title
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
Description
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame
Day 3
Title
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
Description
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame
Day 14
Title
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
Description
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame
Day 28
Title
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
Description
Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Change From Baseline in Schiff Sensitivity Score at Day 3, 14, 28, 56
Description
Evaporative air sensitivity will be assessed on the facial surfaces of teeth by directing 1 second application of air from dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin and from distance of approximately 1 cm. Participant response to stimulus will be evaluated using Schiff sensitivity scale following administration of evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates improvement. Adjusted mean change from baseline will be derived from analysis of covariance (ANCOVA) model which included treatment as a factor and baseline Schiff sensitivity score as a covariate with change from baseline as dependent variable.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Tactile Threshold at Day 3, 14, 28, 56
Description
Tactile sensitivity will be assessed for eligible teeth using constant pressure probe (Yeaple probe). The probe tip will be placed perpendicular to facial surface of tooth and drawn slowly across exposed dentine. After each application, participant will be asked whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gives two consecutives 'yes' responses will be recorded as the tactile threshold (g). At Baseline, the maximum force will be 20g; at all subsequent visits,80g. If no sensitivity will be found at the upper limit, the tactile threshold will be recorded as >20 g (Baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement. Adjusted mean change from baseline will be derived from ANCOVA model which included treatment as factor and baseline tactile sensitivity as covariate with change from baseline as dependent variable.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Day 3, 14, 28, 56
Description
All participants will score question No. 7 to 9 ([Q7: On a scale of 1 to 10 how intense are the sensations?] section 1 of DHEQ on a scale of 1 to 10, where 1=not at all intense and 10=Worst imaginable, [Q8: On a scale of 1 to 10 how bothered are you by any sensations?] section 1 of DHEQ on a scale of 1 to 10, where 1=not at all bothered and 10=Extremely bothered, [Q 9: On a scale of 1 to 10 how well you can tolerate the sensations?] section 1 of DHEQ on a scale of 1 to 10, where 1=Can easily tolerate and 10=Can't tolerate at all). Section 1 asks questions about participant's sensitive teeth and the impact it has on participant's everyday life.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Mean Score of DHEQ Total Score (Section 2 Question 1-15) at Day 3, 14, 28, 56
Description
All participants will score 15 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 is having questions about the ways in which the sensations in the teeth affected participants in daily life. Total score will be derived from the sum of scores in single domains: Restrictions (Section 2, Q1-3), Adaptation (Section 2, Q4-6), Social Impact (Section 2, Q7 to 9), Emotional Impact (Section 2, Q10 to 12), and Identity (Section 2, Q13 to 15).
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (Section 2 Questions 1 to 3)
Description
All participants will score 3 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: It takes a long time to finish some foods and drinks because of sensations, and Q3: There have been times when I have had problems eating ice cream because if these sensations.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (Section 2 Questions 4 to 6)
Description
All participants will score 3 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q4: I have to change the way I eat or drink certain things, Q5: I have to be careful how I breathe on a cold day, Q6: When eating some foods I have made sure they don't touch certain teeth.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (Section 2 Questions 7 to 9)
Description
All participants will score 3 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q7: Because of sensations I take longer than others to finish meal, Q8: I have to be careful what I eat when I am with others because of sensation in my teeth, Q9: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (Section 2 Questions 10 to 12)
Description
All participants will score 8 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q10: I have been anxious that something I eat or drink might cause sensations in my teeth, Q11: The sensations in my teeth have been irritating, Q12: The sensations in my teeth have been annoying.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Mean DHEQ Score of Domain - Identity (Section 2 Questions 13 to 15)
Description
All participants will score 3 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q13: Having these sensations in my teeth makes me feel old, Q14: Having these sensations in my teeth makes me feel damaged, Q15: Having these sensations in my teeth makes me feel as though I am unhealthy.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Mean Numeric Rating Scale (NRS) Score at Baseline, Day 3, 14, 28, 56
Description
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a participant selects the number (0-10) that best reflects the intensity of the discomfort caused by their sensitivity. Where 0 = no discomfort and 10 = worst discomfort imaginable.
Time Frame
Baseline, Day 3, 14, 28, 56
Title
Change From Baseline in Mean NRS Score at Day 3, 14, 28, 56
Description
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a participant selects the number (0-10) that best reflects the intensity of the discomfort caused by their sensitivity. Where 0 = no discomfort and 10 = worst discomfort imaginable.
Time Frame
Baseline, Day 3, 14 , 28 , 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of a signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any study procedures are performed. Participant who is willing and able to comply with scheduled visits, product usage requirements and other study procedures. Participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history, or upon oral examination, that would impact the participant's safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements. Female participant of child-bearing potential and at risk for pregnancy who agrees to use a highly effective method of contraception throughout the study and for at least 5 days after the last use of assigned study product. AT VISIT 1 (Screening): Participant must have a self-reported history of tooth sensitivity lasting more than six months but not more than 10 years. a minimum of 20 natural teeth. a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH; each tooth must meet the following criteria: exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR). MGI score = 0 adjacent to the test area (exposed dentine) only (Lobene et al.,1986) clinical mobility = 0 (Laster et al., 1975) Dentin Hypersensitivity (DH) as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to <= 20 gram (g); Schiff sensitivity score greater than or equal to >= 2). AT VISIT 2 (Baseline): Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre molars) with DH, as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to <= 20 g; Schiff sensitivity score >= 2) at the Screening and Baseline visits. Note: All teeth which meet the eligibility criteria at Screening (Visit 1) should be assessed by tactile and evaporative (air) stimuli at Baseline (Visit 2). The examiner will select two 'test teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both Screening and Baseline. Test teeth should not be adjacent to each other and preferably in different quadrants. Exclusion Criteria: Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family. Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of study entry and/or during study participation. Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. Female participant who is pregnant (as evidenced by a positive urine pregnancy test (UPT) at Screening) or intending to become pregnant during the study. Female participant who is breastfeeding. Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds). Participant who is unwilling or unable to comply with the Lifestyle Considerations. Participant with a recent history (within the last year) of alcohol or other substance abuse. Participant who has participated in another tooth sensitivity study within 8 weeks of Screening. Participant who has used an oral care product indicated for the relief of DH or care of sensitive teeth within 8 weeks of Screening (participants will be required to verbally confirm the name of their current oral care products to enable site staff to verify the absence of known sensitivity ingredients). Participant who has had dental prophylaxis within 4 weeks of Screening. Participant who has had a teeth bleaching procedure within 8 weeks of Screening. Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening. Participant who has had scaling or root planning within 3 months of Screening. Participant with gross periodontal disease. Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy. Participant with a tongue or lip piercing. Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator, would impact study outcomes. Participant with multiple dental implants which, in the opinion of the investigator, would impact study outcomes. Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer. SPECIFIC DENTITION EXCLUSIONS FOR 'TEST TEETH': Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening. Tooth with exposed dentine but with deep, defective or facial restorations. Tooth with full crown or veneer. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator, would impact study outcomes. Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentine. Sensitive tooth not expected to benefit from use of a sensitivity toothpaste in the opinion of the investigator Participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, antidepressants, mood-altering and anti-inflammatory drugs). AT VISIT 1 (Screening): Participant who has taken antibiotics in the 2 weeks prior to the Screening visit. - AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the Baseline visit, during the acclimatisation period. Participant who is taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia. Participant who requires antibiotic prophylaxis for dental procedures. Participant who has previously been enrolled in this study. Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Facility Information:
Facility Name
Bristol Dental School, University of Bristol
City
Bristol
ZIP/Postal Code
BS1 2LY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

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Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth

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