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CompletedNCT03741309Updated Nov 14, 2018

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

A Phase 2 interventional study of 5% fluorocalcium phosphosilicate dentifrice and Calcium sodium phosphosilicate in Dentinal Hypersensitivity, sponsored by Government Dental College and Research Institute, Bangalore. Completed at 1 site in India. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-14.

Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Dentinal Hypersensitivity

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Keywords

  • dentinal hypersensitivity
  • visual analog scale
03

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
131 participants (actual)

Study arms

  • Active comparator
    Group I

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

    Other: 5% fluorocalcium phosphosilicate dentifrice

  • Sham comparator
    Group II

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

    Other: Calcium sodium phosphosilicate

  • Placebo comparator
    Group III

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

    Other: Placebo dentrifice

Interventions

  • Other5% fluorocalcium phosphosilicate dentifrice

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

  • OtherCalcium sodium phosphosilicate

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

  • OtherPlacebo dentrifice

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

05

What researchers measure

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.

    Time frame: Change in VAS score from Baseline to 6 weeks

06

Study locations

1 site
  • Department of Periodontics, GDCRI Bangalore
    Bangalore, Karnataka 560002, India
07

Registry details

Key details

Study ID
NCT03741309
Lead sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
Group Pharma
Responsible party
Dr. A R Pradeep (Head and Professor, Government Dental College and Research Institute, Bangalore) — Principal investigator
First posted
Nov 14, 2018
Start date
Dec 20, 2017
Primary completion
Feb 16, 2018
Completion
Feb 24, 2018
Last update
Nov 14, 2018

Study contacts

Avani R Pradeep, MDS
principal investigator · GDCRI, Bangalore, INDIA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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