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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2018-02-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dentinal Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

dentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks.

Group Type ACTIVE_COMPARATOR

5% fluorocalcium phosphosilicate dentifrice

Intervention Type OTHER

dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks

Group 2

dentifrice containing 5% potassium nitrate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .

Group Type SHAM_COMPARATOR

5% potassium nitrate dentifrice

Intervention Type OTHER

5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.

Group 3

dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .

Group Type PLACEBO_COMPARATOR

Placebo dentrifice

Intervention Type OTHER

placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks

Interventions

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5% fluorocalcium phosphosilicate dentifrice

dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks

Intervention Type OTHER

5% potassium nitrate dentifrice

5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.

Intervention Type OTHER

Placebo dentrifice

placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes