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

NCT ID: NCT02226562

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-02
• Study Completion Date: 2014-12-05

Brief Summary

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.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Potassium nitrate and sodium fluoride

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

Group Type: EXPERIMENTAL

Potassium nitrate and sodium fluoride

Intervention Type: DRUG

3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride

Standard fluoride dentifrice

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

Group Type: OTHER

Standard fluoride dentifrice

Intervention Type: DRUG

Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP

Interventions

Potassium nitrate and sodium fluoride

3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride

Intervention Type: DRUG

Standard fluoride dentifrice

Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Fort Wayne, Indiana, United States

Countries

United States

References

Hall C, Sufi F, Milleman JL, Milleman KR. Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity: An 8-week randomized controlled study. J Am Dent Assoc. 2019 Mar;150(3):204-212. doi: 10.1016/j.adaj.2018.10.023.

Reference Type: DERIVED

PMID: 30803493 (View on PubMed)

Other Identifiers

RH02492

Identifier Type: OTHER

Identifier Source: secondary_id

202196

Identifier Type: -

Identifier Source: org_study_id