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Completed

NCT Number: NCT03741309

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

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.

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Key information

Conditions

Dentinal Hypersensitivity

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Periodontics, GDCRI Bangalore

Bangalore, Karnataka, 560002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5% fluorocalcium phosphosilicate dentifrice

Other

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

Calcium sodium phosphosilicate

Other

Calcium sodium phosphosilicatand VAS score assessed at Baseline, 2weeks, 6 weeks.

Placebo dentrifice

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Collaborators

  • Group Pharma

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2018
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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