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

NCT03741309 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/Ph.D/5/2016-2017N
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dentinal Hypersensitivity

Keywords

dentinal hypersensitivity; visual analog scale

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group I

ACTIVE COMPARATOR

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

Other: 5% fluorocalcium phosphosilicate dentifrice

Group II

SHAM COMPARATOR

dentifrice containing Calcium sodium phosphosilicate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .

Other: Calcium sodium phosphosilicate

Group III

PLACEBO COMPARATOR

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

Other: Placebo dentrifice

Interventions

5% fluorocalcium phosphosilicate dentifrice OTHER

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

Group I

Calcium sodium phosphosilicate OTHER

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

Group II

Placebo dentrifice OTHER

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

Group III

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead
• Group Pharma: collaborator

Study Sites (1)

Department of Periodontics, GDCRI Bangalore

Bangalore, Karnataka, 560002, India

Location

Study Officials

• Avani R Pradeep, MDS

  GDCRI, Bangalore, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and Professor

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 14, 2018
• Study Start: December 20, 2017
• Primary Completion: February 16, 2018
• Study Completion: February 24, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

IN (1)