Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluorides; Fluorophosphate; Tin Fluorides

Criteria

Inclusion Criteria:

• Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.

• Participants with minimum of 20 natural teeth.

• At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.

1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.

2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.

3. Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.

Exclusion Criteria:

• 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 dry mouth.

• Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.

• Participant using of a desensitising dentifrice within 6 weeks of screening