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Clinical Trials/NCT03741309
NCT03741309
Completed
Phase 2

Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate and to a Placebo on Dentinal Hypersensitivity : a Randomized Clinical Trial

Government Dental College and Research Institute, Bangalore1 site in 1 country131 target enrollmentDecember 20, 2017

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Dentinal Hypersensitivity
Sponsor
Government Dental College and Research Institute, Bangalore
Enrollment
131
Locations
1
Primary Endpoint
Visual Analogue Scale score for Dentinal Hypersensitivity
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing calcium sodium phosphosilicate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Detailed Description

A total of 131 subjects were divided into 3 groups randomly. Group I was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group II was given the dentifrice containing calcium sodium phosphosilicate and group III was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

Registry
clinicaltrials.gov
Start Date
December 20, 2017
End Date
February 24, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Government Dental College and Research Institute, Bangalore
Responsible Party
Principal Investigator
Principal Investigator

Dr. A R Pradeep

Head and Professor

Government Dental College and Research Institute, Bangalore

Eligibility Criteria

Inclusion Criteria

  • The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4.

Exclusion Criteria

  • Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.

Outcomes

Primary Outcomes

Visual Analogue Scale score for Dentinal Hypersensitivity

Time Frame: Change in VAS score from Baseline to 6 weeks

Based on a 10-cm VAS score which was used to measure tooth sensitivity, a pain-free response was allotted a score of zero whereas a score of 10 was given to subjects with excruciating pain or discomfort.

Study Sites (1)

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