Clinical Efficacy in reducing dentinal hypersensitivity of a dentifrice containing 8% strontium acetate in providing instant and lasting relief
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Dabur India Limited
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The test product provides instant relief and long lasting relief
Study Overview
Brief Summary
The study was open label, monocentric, single 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 30 subjects ages between 20-60 years (both the ages inclusive) were enrolled in the study. All the subjects completed the study and no drop outs occurred. There was no side effects/ adverse event during the period of the study.
The test product was found to exhibit instant relief after a single direct topical application and lasting dentinal hypersensitivity relief over a period of 6 weeks twice daily application. Sensitivity was assessed by means of tactile and evaporative stimuli.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- 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
- •1.Subjects who had dental pathology causing pain similar to cervical dentinal hypersensitivity (such as teeth with caries) 2.Subjects with 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) 3.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 30 days 4.Subjects who were pregnant or lactating 5.Subjects who had any systemic diseases and/or the presence of a vital bleaching history.
Outcomes
Primary Outcomes
The test product provides instant relief and long lasting relief
Time Frame: Baseline, 60 seconds, 3 weeks, 6 weeks
Secondary Outcomes
- Overall safety of the Subjects throughout the study period(Baseline, 60 seconds, 3 weeks, 6 weeks)