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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03741309
Other study ID # GDCRI/ACM/PG/Ph.D/5/2016-2017N
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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