A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.

Study Overview
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Brief Summary
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This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.

Official Title
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A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Other: Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)
* Other: Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)
* Other: Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )


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. Participants will be 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 wellbeing 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)<br>Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 1 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. | Other: Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)<br>* 1.5% w/w KOX, 0ppm F, pH 7.0<br>|
| Experimental: Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)<br>Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 2 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. | Other: Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)<br>* 2.0% w/w KOX, 45ppm F, pH 4.5<br>|
| Placebo Comparator: Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )<br>Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. | Other: Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )<br>* 0% w/w KOX 0ppm F, pH 4.5<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 at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) | Schiff sensitivity score was assessed by 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. | Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2) | Schiff sensitivity score was assessed by 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. | Baseline and Week 8 | 
| Change From Baseline in Schiff Sensitivity Score at Week 4 | Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using 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 syimulus; 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. | Baseline and Week 4 | 
| Change From Baseline in Tactile Threshold at Week 4 and 8 | Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied 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 without the participant reporting 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 greater the tactile threshold, the less sensitive the tooth. | Baseline, Week 4 and 8 | 
| Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). | Baseline, Week 4 and 8 |