A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.

• Status: Completed
• Trial end date: 2015-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluorides

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