Clinical trial NCT02753075: A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.
Official title: A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-04-27
Enrollment: 240
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: 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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
timeFrame: Baseline, Week 8
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
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: