A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/29/2018 |
| Start Date: | September 8, 2015 |
| End Date: | December 18, 2015 |
A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
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.
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.
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
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