Clinical trial NCT02226562: Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Official title: A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentin Sensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change From Baseline in Schiff Sensitivity Score at Week 8
timeFrame: Baseline to 8 week
Secondary outcomes:
measure: Mean Change From Baseline in Schiff Sensitivity Score at Week 4
timeFrame: Baseline to 4 week
measure: Mean Change From Baseline in Tactile Threshold at Week 8
timeFrame: Baseline to 8 week
measure: Mean Change From Baseline in Tactile Threshold at Week 4
timeFrame: Baseline to 4 week
measure: Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8
timeFrame: Baseline to 8 week
measure: Mean Change From Baseline in VRS at Week 4
timeFrame: Baseline to 4 week
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.