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

Dentinal Hypersensitivity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741309
• Other study ID #: GDCRI/ACM/PG/Ph.D/5/2016-2017N
• Status: Completed
• Phase: Phase 2
• Start date: December 20, 2017
• Est. completion date: February 24, 2018

Study information

• Verified date: November 2018
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: February 24, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentinal Hypersensitivity
• Hypersensitivity

Intervention

Other:
• 5% fluorocalcium phosphosilicate dentifrice
dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks.
• Calcium sodium phosphosilicate
Calcium sodium phosphosilicatand VAS score assessed at Baseline, 2weeks, 6 weeks.
• Placebo dentrifice
placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.

Locations

Country	Name	City	State
India	Department of Periodontics, GDCRI Bangalore	Bangalore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore	Group Pharmaceuticals Ltd,Bangalore,India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 6 weeks