Clinical trial NCT01494649: Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity
Official title: A Pilot Clinical Study Investigating the Efficacy of a Toothpaste in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentinal Sensitivity
Hypersensitivity
Keywords: dentinal
hypersensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 118
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 pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.


Eligibility criteria: Inclusion:

* Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
* Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
* Teeth having a gingival index score of less than or equal to 1
* Teeth with a clinical mobility less than or equal to 1
* sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).

Exclusion:

* Presence of chronic debilitating disease which could affect study outcomes.
* Any condition which 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, or not expected to respond to treatment with an over-the counter dentifrice.
* Daily doses of a medication which could interfere with the perception of pain.
* Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
* Individuals who require antibiotic prophylaxis for dental procedures.

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
timeFrame: Baseline and immediately after treatment administration
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3
timeFrame: Baseline and Day 3
measure: Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14
timeFrame: Baseline and Day 14
measure: Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment
timeFrame: Baseline and immediately after treatment administration
measure: Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3
timeFrame: Baseline and Day 3
measure: Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14
timeFrame: Baseline and Day 14
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: BioSci Research America, Inc.
state: Nevada
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.