Clinical trial NCT02371616: Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Official title: A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentine Sensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.

Detailed description: A single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after 4 and 8 weeks twice daily treatment.

Eligibility criteria: Inclusion Criteria:

* subjects in good general health with no clinically significant/ relevant abnormalities of 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) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment
* 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:

* subjects 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+C60
* scaling or root planing 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: Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
timeFrame: At Baseline and Week 8
Secondary outcomes:
measure: Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4
timeFrame: At Baseline and Week 4
measure: Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
timeFrame: At Baseline, Week 4 and Week 8
measure: Change From Baseline in Tactile Threshold at Week 4 and Week 8
timeFrame: At Baseline, Week 4 and Week 8
Other outcomes:
Locations:
city: Ellesmere Port
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Maldon
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Wirral
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: