A Clinical trial to evaluate the efficacy and comparison of a dentifrice containing Sodium Fluoride; 8% Strontium Acetate, Strontium Acetate (in Herbal Base) and two different Herbal dentifrices in reducing Dentinal Hypersensitivity
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Dabur India Limited
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Reduction of dentin hypersensitivity immediately after a single self-application, as well as after a subsequent twice daily brushing for a period of 6 weeks
Study Overview
Brief Summary
The study was randomized, monocentric, parallel group, open label, four arm trial efficacy study. The duration of treatment was conducted for a period of 6 weeks on subjects and included a total of 4 visits (Baseline, 60 seconds, 3 weeks and 6 weeks). The subjects who satisfy inclusion/exclusion criteria were enrolled after obtaining informed consent. A total of 140 subjects were randomly divided into four experimental groups and ages between 20-60 years (both the ages inclusive) were enrolled in the study. A total of 139 subjects completed the six weeks study period. There was no side effects/ adverse event during the period of the study. The dentin sensitivity assessment was done using the tactile and air blast (Schiff’s Scale) hypersensitivity method.
Instant and lasting relief from dentin hypersensitivity was reported at the end of 6 week study period with test toothpaste A and B but not with toothpaste C and D.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects with dental hypersensitivity complaints.
Exclusion Criteria
- •Subjects who had dental pathology causing pain similar to cervical dentinal hypersensitivity (such as teeth with caries, the presence of orthodontic appliances and restorations and/or the presence of a history of periodontal surgery in the area of the tooth during the previous three months)
- •Subjects who had taken any medication
- •Subjects who received professional treatment with desensitizing agents in the previous six months
- •Subjects who received any treatment in the past 3 months
- •Subjects who were pregnant or lactating
- •Subjects who had any systemic diseases and/or the presence of a vital bleaching history.
Outcomes
Primary Outcomes
Reduction of dentin hypersensitivity immediately after a single self-application, as well as after a subsequent twice daily brushing for a period of 6 weeks
Time Frame: Baseline, 60 seconds, 3 weeks, 6 weeks
Secondary Outcomes
No secondary outcomes reported