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

NCT03738514 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/Ph.D/5/2016-2017
• Study Type: interventional
• Target: 120
• 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 potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Conditions

Dentinal Hypersensitivity

Keywords

Dentinal Hypersensitivity; Visual Analogue Score

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 12 weeks

Study Arms (3)

Group 1

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 2

SHAM COMPARATOR

dentifrice containing 5% potassium nitrate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .

Other: 5% potassium nitrate dentifrice

Group 3

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 1

5% potassium nitrate dentifrice OTHER

5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.

Group 2

Placebo dentrifice OTHER

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

Group 3

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 9, 2018
• First Posted: November 13, 2018
• Study Start: December 22, 2017
• Primary Completion: February 9, 2018
• Study Completion: February 22, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

IN (1)