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CompletedNCT03738514Updated Nov 13, 2018

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

A Phase 2 interventional study of 5% fluorocalcium phosphosilicate dentifrice and 5% potassium nitrate dentifrice 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 2018-11-13.

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

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2017, registered Nov 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
120
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 potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Read the detailed description

A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group 2 was given the dentifrice containing potassium nitrate and group 3 was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

02

Conditions studied

  • Dentinal Hypersensitivity

Keywords

  • Dentinal Hypersensitivity
  • Visual Analogue Score
03

In context

Lead sponsor

Government Dental College and Research Institute, Bangalore is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

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

Study arms

  • Active comparator
    Group 1

    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 2

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

    Other: 5% potassium nitrate dentifrice

  • Placebo comparator
    Group 3

    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

  • Other5% potassium nitrate dentifrice

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

  • OtherPlacebo dentrifice

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

06

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 12 weeks

07

Study locations

1 site
  • Department of Periodontics, GDCRI Bangalore
    Bangalore, Karnataka 560002, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03738514
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 13, 2018
Start date
Dec 22, 2017
Primary completion
Feb 9, 2018
Completion
Feb 22, 2018
Last update
Nov 13, 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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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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