Last updated: 03/10/2021 06:30:22
Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief from Dentinal Hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief from Dentinal Hypersensitivity
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in Schiff sensitivity score at week 8
Timeframe: Baseline to 8 week
Secondary outcomes:
Mean change from baseline in Schiff sensitivity score at week 4
Timeframe: Baseline to 4 week
Mean change from baseline in tactile threshold at week 8
Timeframe: Baseline to 8 week
Mean change from baseline in tactile threshold at week 4
Timeframe: Baseline to 4 week
Mean change from baseline in Visual Rating Scale (VRS) at week 8
Timeframe: Baseline to 8 week
Mean change from baseline in VRS at week 4
Timeframe: Baseline to 4 week
Interventions:
Drug: Potassium nitrate and sodium fluoride
Drug: Standard fluoride dentifrice
Enrollment:
191
Observational study model:
Not applicable
Primary completion date:
2014-05-12
Time perspective:
Not applicable
Clinical publications:
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
Medical condition
Dentin Sensitivity
Product
SKF46656, potassium nitrate, potassium nitrate/sodium fluoride, sodium fluoride
Collaborators
Not applicable
Study date(s)
September 2014 to December 2014
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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. a) Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. b) Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1. c) 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 location(s)
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2014-05-12
Actual study completion date
2014-05-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity.
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