Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Dentin Sensitivity

Treatments: Drug: Potassium nitrate and sodium fluoride; Drug: Standard fluoride dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT02226562

RH02492 (Other Identifier)

202196

Details and patient eligibility

About

The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.

Enrollment: 191 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants in good general health, 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 four, non-adjacent teeth.

  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 participant 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.
• In the 8 weeks prior to screening use of an oral care product indicated for the relief of DH.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

191 participants in 2 patient groups

Potassium nitrate and sodium fluoride

Experimental group

Description:

3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride

Treatment:

Drug: Potassium nitrate and sodium fluoride

Standard fluoride dentifrice

Other group

Description:

Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)

Treatment:

Drug: Standard fluoride dentifrice