Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate on Dentinal Hypersensitivity

Phase 2

Completed

• Conditions: Dentinal Hypersensitivity
• Interventions: Other: Placebo dentrifice; Other: 5% fluorocalcium phosphosilicate dentifrice; Other: Calcium sodium phosphosilicate

• Registration Number: NCT03741309
• 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 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.

Study Timeline

• Study Start: 2017-12-20
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-24
• Status Verified: 2018-11
• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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 III	Placebo dentrifice	dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks.
Group I	5% fluorocalcium phosphosilicate dentifrice	dentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks.
Group II	Calcium sodium phosphosilicate	dentifrice containing Calcium sodium phosphosilicate 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 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.

Trial Locations

Locations (1)

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