Clinical trial NCT01827670: Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Official title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dentine Hypersensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-04-09
Enrollment: 119
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: Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.


Eligibility criteria: Inclusion Criteria:

* Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
* Participants with minimum of 20 natural teeth.
* At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.

  1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
  2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
  3. Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.

Exclusion Criteria:

* 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 dry mouth.
* Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
* Participant using of a desensitising dentifrice within 6 weeks of screening

Primary outcomes:
measure: Mean Change From Baseline in Schiff Sensitivity Score
timeFrame: Baseline-Week 8
Secondary outcomes:
measure: Mean Change From Baseline in Schiff Sensitivity Score
timeFrame: Baseline-Week 4
measure: Mean Change From Baseline in Tactile Sensitivity
timeFrame: Baseline-Week 8
measure: Mean Change From Baseline in Tactile Sensitivity
timeFrame: Baseline-Week 4
measure: Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)
timeFrame: Baseline-Week 4
measure: Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)
timeFrame: Baseline - Week 8
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Parkinson CR, Jeffery P, Milleman JL, Milleman KR, Mason S. Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial. Am J Dent. 2015 Aug;28(4):190-6.