Comparison of Efficacy of 5% Fluorocalcium Phosphosilicate Dentifrice and Potassium Nitrate Dentifrice on Dentinal Hypersensitivity

Phase 2

Completed

• Conditions: Dentinal Hypersensitivity
• Interventions: Other: Placebo dentrifice; Other: 5% fluorocalcium phosphosilicate dentifrice; Other: 5% potassium nitrate dentifrice

• Registration Number: NCT03738514
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

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.

Study Timeline

• Study Start: 2017-12-22
• Primary Completion: 2018-02-09
• Study Completion: 2018-02-22
• Status Verified: 2018-11
• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Study First Posted: 2018-11-13
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	Placebo dentrifice	dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .
Group 1	5% fluorocalcium phosphosilicate dentifrice	dentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks.
Group 2	5% potassium nitrate dentifrice	dentifrice containing 5% potassium nitrate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale score for Dentinal Hypersensitivity	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.

Trial Locations

Locations (1)

Department of Periodontics, GDCRI Bangalore; 🇮🇳 Bangalore, Karnataka, India