- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924350
The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH)
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bristol, United Kingdom, BS1 2LY
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consent: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged 18-65 years inclusive
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination. b) Absence of any condition that would impact on the participants safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
- At Visit 1 (Screening): a) Self-reported history of DH lasting more than six months but not more than 10 years. b) Minimum of 20 natural teeth. c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: -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 [Lobene, 1986] and a clinical Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response) mobility of ≤1, -Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
- At Visit 2, Baseline (Pre-treatment):Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:-Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2)
- Teeth which meet the EAR, MGI and mobility inclusion criteria and none of the dentition exclusion criteria at Screening should be assessed by tactile stimulus at Visit 2. Those teeth which meet the required tactile threshold (Yeaple ≤ 20g) should then be assessed by evaporative air stimulus. When two teeth that meet the study criteria are identified, no further testing is necessary
Exclusion Criteria:
- A woman who is known to be pregnant or who is intending to become pregnant over the duration of the study
- A woman who is breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Participation in study 205084
- Recent history (within the last year) of alcohol or other substance abuse
- An employee of the sponsor or the study site or members of their immediate family The site for this protocol is the Clinical trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials unit are eligible to participate
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes
- Any condition which, in the opinion of the investigator, causes xerostomia
- Dental prophylaxis within 4 weeks of Screening
- Tongue or lip piercing or presence of dental implants on the selected Test Teeth
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening
- Vital teeth bleaching within 8 weeks of Screening
- Desensitizing treatment within 8 weeks of Screening (professional sensitivity treatments and non-dentifrice sensitivity treatments)
- 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, 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 of exposed dentine
- Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
- Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs
- Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline
- Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia
- Any participants who, in the judgment of the investigator, should not participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Test dentifrice containing stannous fluoride
All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice.
Participants brushed their teeth for 3 days twice daily (morning /evening).
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Supervised direct application (Day 0): Participants applied a pea-sized dose of test dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment. Supervised brushing (Day 0, before leaving the site) and Home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed each of the 2 qualifying test teeth first, followed by their whole mouth for at least 60 sec. Participants were permitted to rinse with 5 mL tap water (room temperature) for 5 sec. maximum after brushing on supervised brushing (Day 0) and were also permitted to rinse with tap water after brushing on home use (3 days). |
Active Comparator: Control dentifrice containing sodium monofluorophosphate
All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice.
Participants brushed their teeth for 3 days twice daily (morning /evening).
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Supervised direct application (Day 0): participants applied a pea-sized dose of control dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment. Supervised brushing (Day 0, before leaving the site) and home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed their whole mouth thoroughly for at least 60 sec. Participants were permitted to rinse with 5mL tap water (room temperature) for 5 sec. maximum after brushing in supervised brushing on Day 0 and were also permitted to rinse with tap water after brushing on home use (3 days). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Schiff Sensitivity Score on Day 3
Time Frame: Baseline, Day 3
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The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 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 reduction in Schiff Sensitivity score indicates improvement in sensitivity.
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Baseline, Day 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline (Day 0 Pre-treatment) in Schiff Sensitivity Score on Day 0 (After 60 Seconds of Single Direct Application)
Time Frame: At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0
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The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 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 reduction in Schiff Sensitivity score indicates improvement in sensitivity.
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At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0
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Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3
Time Frame: At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3
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The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10gram (g) and raised in increments of 10g until the tactile threshold or maximum force was 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 were recorded as the tactile threshold.
Higher tactile threshold means less sensitive tooth.
At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
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At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 207212
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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