Study Investigating Efficacy of an Occluding Dentifrice for Dentine Hypersensitivity

Study Overview
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Brief Summary
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This study will investigate the efficacy of an experimental dentifrice containing 0.454% weight/weight (w/w) stannous fluoride in relieving dentine hypersensitivity (DH) after twice daily brushing, over a 2 week treatment period compared with a standard fluoride dentifrice.

Official Title
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Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Other: 0.454% w/w stannous fluoride (1100ppm fluoride)
* Other: 0.76% sodium monofluorophosphate (1000ppm fluoride)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Participant is male or female aged between 18 and 65 years inclusive. Good general and mental health with, in the opinion of the investigator or medically qualified designee. No clinically significant and relevant abnormalities in medical history or upon oral examination. Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements. Self-reported history of dentinal hypersensitivity (DH) lasting more than(>) six months but not > 10 years. Good general oral health, with a minimum of 20 natural teeth. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline. Exclusion Criteria: Women who are pregnant or breast-feeding . 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 two weeks of Baseline. Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts. 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. 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. Recent history (within the last year) of alcohol or other substance abuse. Dental prophylaxis within four weeks of Screening, tongue or lip piercing or presence of dental implants. Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments). Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening. Teeth bleaching within eight weeks of Screening. 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 toothpaste in the opinion of the Investigator. Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening. Individuals who require antibiotic prophylaxis for dental procedures. Any participant who, in the judgment of the investigator, should not participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Dentifrice<br>Participants will be instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants will then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. | Other: 0.454% w/w stannous fluoride (1100ppm fluoride)<br>* Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride)<br>|
| Placebo Comparator: Control Dentifrice<br>Participants will be instructed to apply a full brush head of toothpaste containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants will then brush the whole mouth thoroughly for at least 1 minute. | Other: 0.76% sodium monofluorophosphate (1000ppm fluoride)<br>* Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Schiff Sensitivity Score on Day 14 | Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. | Baseline, Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Schiff Sensitivity Score on Day 7 | Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. | Baseline, Day 7 | 
| Change From Baseline in Tactile Threshold on Day 7 and 14 | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin 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. | Baseline, Day 7 and Day 14 |