Back to resultsA Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Oral Rinse 1
Experimental Oral Rinse 2
Placebo Oral Rinse
Fluoride toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon 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) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
- 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:
- Participants 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
- Scaling or root planning 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Experimental Oral Rinse 1
Experimental Oral Rinse 2
Placebo Oral Rinse
Arm Description
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks.
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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.
Secondary Outcome Measures
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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 in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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 in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.
Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.
Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain). A reduction in the score is indicative of an improvement in sensitivity.
Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02753075
Brief Title
A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.
Official Title
A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 8, 2015 (undefined)
Primary Completion Date
December 1, 2015 (Actual)
Study Completion Date
December 18, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Oral Rinse 1
Arm Type
Experimental
Arm Description
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks.
Arm Title
Experimental Oral Rinse 2
Arm Type
Experimental
Arm Description
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
Arm Title
Placebo Oral Rinse
Arm Type
Placebo Comparator
Arm Description
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Experimental Oral Rinse 1
Intervention Description
Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5
Intervention Type
Device
Intervention Name(s)
Experimental Oral Rinse 2
Intervention Description
Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5
Intervention Type
Other
Intervention Name(s)
Placebo Oral Rinse
Intervention Description
Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5
Intervention Type
Drug
Intervention Name(s)
Fluoride toothpaste
Intervention Description
Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
Primary Outcome Measure Information:
Title
Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
Description
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
Description
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Description
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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.
Time Frame
Baseline, Week 4
Title
Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
Description
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.
Time Frame
Baseline, Week 4
Title
Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8
Description
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
Description
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain). A reduction in the score is indicative of an improvement in sensitivity.
Time Frame
Baseline, Week 4
Title
Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
Description
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon 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) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
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:
Participants 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
Scaling or root planning 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
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
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A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.
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