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

NCT02226562 | Completed Phase 2 Results

• 2 other identifiers: 202196RH02492
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Schiff Sensitivity Score at Week 8

  The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.

  Baseline to 8 week

Secondary Outcomes (5)

• Mean Change From Baseline in Schiff Sensitivity Score at Week 4

  Baseline to 4 week

• Mean Change From Baseline in Tactile Threshold at Week 8

  Baseline to 8 week

• Mean Change From Baseline in Tactile Threshold at Week 4

  Baseline to 4 week

• Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8

  Baseline to 8 week

• Mean Change From Baseline in VRS at Week 4

  Baseline to 4 week

Study Arms (2)

Potassium nitrate and sodium fluoride

EXPERIMENTAL

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

Drug: Potassium nitrate and sodium fluoride

Standard fluoride dentifrice

OTHER

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

Drug: Standard fluoride dentifrice

Interventions

Potassium nitrate and sodium fluoride DRUG

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

Potassium nitrate and sodium fluoride

Standard fluoride dentifrice DRUG

Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP

Standard fluoride dentifrice

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
• Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
• Teeth that are determined to be sensitive by the participant following a 1 second air blast to the cervical margin.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (1)

• 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.

  PMID: 30803493 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

potassium nitrate; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 27, 2014
• Study Start: September 2, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 5, 2014
• Last Updated: August 27, 2018
• Results First Posted: August 26, 2015

Record last verified: 2018-07

Locations

US (1)