A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Dentin Sensitivity
- Sponsor
- GlaxoSmithKline
- Enrollment
- 229
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Schiff Sensitivity Score on Day 3
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This single centre, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice
Detailed Description
This will be a single centre, three day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. Dentinal hypersensitivity will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing
Investigators
Eligibility Criteria
Inclusion Criteria
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- •Aged 18-65 years inclusive
- •Understands and is willing, able and likely to comply with all study procedures and restrictions
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination. b) Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
- •Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years
- •Minimum of 20 natural teeth
- •Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR), Tooth with MGI score =0 adjacent to the test area (exposed dentine) only \[Lobene, 1986\] and a clinical mobility of ≤1, Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
- •Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria: Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2)
Exclusion Criteria
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- •Women who are breast-feeding
- •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 (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- •Previous participation in this study
- •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 or Any condition which, in the opinion of the investigator, causes xerostomia
- •Dental prophylaxis within 4 weeks of Screening or Tongue or lip piercing or presence of dental implants
- •Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening and teeth bleaching within 8 weeks of Screening
Outcomes
Primary Outcomes
Change From Baseline in Schiff Sensitivity Score on Day 3
Time Frame: Baseline to Day 3
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
Secondary Outcomes
- Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application(Baseline to 60 seconds post first treatment)
- Change From Baseline in Tactile Threshold Post First Treatment by Direct Application(Baseline to 60 seconds post first treatment)
- Change From Baseline in Tactile Threshold on Day 3(Baseline to Day 3)