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

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

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.

Study Overview

• Status: Completed
• Conditions: Dentinal Hypersensitivity
• Intervention / Treatment: Other: 5% fluorocalcium phosphosilicate dentifrice; Other: 5% potassium nitrate dentifrice; Other: Placebo dentrifice

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560002
      • Department of Periodontics, GDCRI Bangalore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; dentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks.	Other: 5% fluorocalcium phosphosilicate dentifrice; dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks
Sham Comparator: Group 2; dentifrice containing 5% potassium nitrate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .	Other: 5% potassium nitrate dentifrice; 5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.
Placebo Comparator: Group 3; dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .	Other: Placebo dentrifice; placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale score for Dentinal Hypersensitivity	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.	Change in VAS score from Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore
• Collaborators: Group Pharma

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): February 9, 2018
• Study Completion (Actual): February 22, 2018

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Dentinal Hypersensitivity; Visual Analogue Score
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: GDCRI/ACM/PG/Ph.D/5/2016-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No