Back to resultsClinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Primary Purpose
Dentine Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Calcium sodium phosphosilicate
Sodium fluoride
Sodium monofluorophosphate
Sponsored by
About this trial
This is an interventional treatment trial for Dentine Sensitivity
Eligibility Criteria
Inclusion Criteria:
- subjects in good general health with no clinically significant/ relevant abnormalities of oral examination
- pre-existing self reported and clinically diagnosed tooth sensitivity
- at screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment
- at baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)
Exclusion Criteria:
- subjects with a known or suspected intolerance or hypersensitivity to study products
- presence of chronic debilitating disease which could affect study outcomes
- any condition which is causing dry mouth
- use of an oral care product indicated for the relief of dentine hypersensitivity
- participation in a DH treatment study in the 8 weeks prior to screening
- taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
- require antibiotic prophylaxis for dental procedures
- dental prophylaxis within 4 weeks of screening
- treatment of periodontal disease within 12 months of screening+C60
- scaling or root planing within 3 months of screening
- tooth bleaching within 8 weeks of screening
- active caries or periodontitis
- partial dentures, orthodontic appliances or dental implants which could affect study outcomes
- Pregnant and breast-feeding females
- Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth with exposed dentine but with deep, defective or facial restorations; teeth used as abutments for fixed or removable partial dentures; teeth with full crowns or veneers, orthodontic bands or cracked enamel; sensitive teeth with contributing aetiologies other than erosion, abrasion or recession
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test dentifrice
Comparator dentifrice
Arm Description
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium flouride
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Secondary Outcome Measures
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Change From Baseline in Tactile Threshold at Week 4 and Week 8
Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02371616
Brief Title
Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Official Title
A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 29, 2014 (Actual)
Primary Completion Date
December 18, 2014 (Actual)
Study Completion Date
December 18, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.
Detailed Description
A single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after 4 and 8 weeks twice daily treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentine Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test dentifrice
Arm Type
Experimental
Arm Description
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium flouride
Arm Title
Comparator dentifrice
Arm Type
Active Comparator
Arm Description
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate
Intervention Type
Device
Intervention Name(s)
Calcium sodium phosphosilicate
Intervention Description
5% w/w calcium sodium phosphosilicate
Intervention Type
Other
Intervention Name(s)
Sodium fluoride
Intervention Description
1426 ppm fluoride as sodium fluoride
Intervention Type
Other
Intervention Name(s)
Sodium monofluorophosphate
Intervention Description
1426 ppm fluoride as sodium monofluorophosphate
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
Description
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Time Frame
At Baseline and Week 8
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4
Description
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Time Frame
At Baseline and Week 4
Title
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
Description
Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Time Frame
At Baseline, Week 4 and Week 8
Title
Change From Baseline in Tactile Threshold at Week 4 and Week 8
Description
Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Time Frame
At Baseline, Week 4 and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
subjects in good general health with no clinically significant/ relevant abnormalities of oral examination
pre-existing self reported and clinically diagnosed tooth sensitivity
at screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment
at baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)
Exclusion Criteria:
subjects with a known or suspected intolerance or hypersensitivity to study products
presence of chronic debilitating disease which could affect study outcomes
any condition which is causing dry mouth
use of an oral care product indicated for the relief of dentine hypersensitivity
participation in a DH treatment study in the 8 weeks prior to screening
taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
require antibiotic prophylaxis for dental procedures
dental prophylaxis within 4 weeks of screening
treatment of periodontal disease within 12 months of screening+C60
scaling or root planing within 3 months of screening
tooth bleaching within 8 weeks of screening
active caries or periodontitis
partial dentures, orthodontic appliances or dental implants which could affect study outcomes
Pregnant and breast-feeding females
Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth with exposed dentine but with deep, defective or facial restorations; teeth used as abutments for fixed or removable partial dentures; teeth with full crowns or veneers, orthodontic bands or cracked enamel; sensitive teeth with contributing aetiologies other than erosion, abrasion or recession
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ellesmere Port
State/Province
Cheshire
ZIP/Postal Code
CH65 4BW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Maldon
State/Province
Essex
ZIP/Postal Code
CM9 5PN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Wirral
ZIP/Postal Code
CH41 6EY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
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