Clinical trial NCT03072719: The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity
Official title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dentine Hypersensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.


Eligibility criteria: Inclusion

* Demonstrates understanding of the study and willingness to participate
* Aged at least 18 to 65 years
* Understands and is willing, able and likely to comply with all study procedures and restrictions
* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
* Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
* Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars)
* At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥ 2) at baseline

Exclusion

* Pregnant or breast-feeding women
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
* Recent history (within the last year) of alcohol or other substance abuse
* An employee of the sponsor or the study site or members of their immediate family
* 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 xerostomia
* Dental prophylaxis within 4 weeks of screening
* Tongue or lip piercing or presence of dental implants
* Professional desensitising treatment within 12 weeks of screening
* Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
* Teeth bleaching within 12 weeks of screening
* Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening
* Tooth 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 of exposed dentine
* Sensitive tooth not expected to respond to treatment with an over-the counter dentifrice in the opinion of the investigator.
* Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients)
* Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain
* Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
* Daily doses of a medication which, in the opinion of the investigator, causes xerostomia
* Individuals who require antibiotic prophylaxis for dental procedures
* Any participant who, in the judgment of the investigator, should not participate in the study.

Primary outcomes:
measure: Change From Baseline in Schiff Sensitivity Score on Day 14
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3
timeFrame: Baseline, post first brushing (after 5 minutes) and Day 3
measure: Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14
timeFrame: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Parkinson CR, Hughes N, Hall C, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity. Am J Dent. 2016 Feb;29(1):25-32.