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Clinical Trials/NCT03738514
NCT03738514
Completed
Phase 2

Comparison Of Efficacy Of Dentifrice Containing 5% Fluorocalcium Phosphosilicate With Dentifrice Containing Potassium Nitrate And Placebo On Dentinal Hypersensitivity: A Triple Masked Randomized Controlled Clinical Trial

Government Dental College and Research Institute, Bangalore1 site in 1 country120 target enrollmentDecember 22, 2017

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Dentinal Hypersensitivity
Sponsor
Government Dental College and Research Institute, Bangalore
Enrollment
120
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 potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Detailed Description

A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group 2 was given the dentifrice containing potassium nitrate and group 3 was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

Registry
clinicaltrials.gov
Start Date
December 22, 2017
End Date
February 22, 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 12 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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