Last updated: 11/07/2018 12:37:02
A study in dentinal hypersensitivity (DH) participants to assess the efficacy of an occluding dentifrice.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief from Dentinal Hypersensitivity
Trial description: This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 against a Placebo Oral Rinse at Week 8
Timeframe: Baseline, Week 8
Secondary outcomes:
Change from Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
Timeframe: Baseline, Week 8
Change from Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Timeframe: Baseline, Week 4
Change from Baseline in Tactile Threshold (gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
Timeframe: Baseline, Week 4
Change from Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8
Timeframe: Baseline, Week 8
Change from Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
Timeframe: Baseline, Week 4
Change from Baseline in VRS of two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
Timeframe: Baseline, Week 8
Interventions:
Device: Experimental Oral Rinse 1
Device: Experimental Oral Rinse 2
Other: Placebo Oral Rinse
Drug: Fluoride toothpaste
Enrollment:
240
Observational study model:
Not applicable
Primary completion date:
2015-18-12
Time perspective:
Not applicable
Clinical publications:
https://doi.org/10.1016/j.jdent.2017.12.004
Medical condition
Dentin Sensitivity
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2015 to December 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon oral examination
- Pre-existing self reported and clinically diagnosed tooth sensitivity
- Participants with a known or suspected intolerance or hypersensitivity to study products
- Presence of chronic debilitating disease which could affect study outcomes
Inclusion and exclusion criteria
Inclusion criteria:
- Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon oral examination
- Pre-existing self reported and clinically diagnosed tooth sensitivity
- At screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
- At baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)
Exclusion criteria:
- Participants with a known or suspected intolerance or hypersensitivity to study products
- Presence of chronic debilitating disease which could affect study outcomes
- Any condition which is causing dry mouth
- Use of an oral care product indicated for the relief of dentine hypersensitivity
- Participation in a DH treatment study in the 8 weeks prior to screening
- Taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
- Require antibiotic prophylaxis for dental procedures
- Dental prophylaxis within 4 weeks of screening
- Treatment of periodontal disease within 12 months of screening
- Scaling or root planning within 3 months of screening
- Tooth bleaching within 8 weeks of screening
- Active caries or periodontitis
- Partial dentures, orthodontic appliances or dental implants which could affect study outcomes
- Pregnant and breast-feeding females
- Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth with exposed dentine but with deep, defective or facial restorations; teeth used as abutments for fixed or removable partial dentures; teeth with full crowns or veneers, orthodontic bands or cracked enamel; sensitive teeth with contributing aetiologies other than erosion, abrasion or recession
Trial location(s)
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2015-18-12
Actual study completion date
2015-18-12
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
Additional information
Not applicable
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