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

Primary Purpose

Dentinal Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
5% fluorocalcium phosphosilicate dentifrice
5% potassium nitrate dentifrice
Placebo dentrifice
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentinal Hypersensitivity focused on measuring Dentinal Hypersensitivity, Visual Analogue Score

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Periodontics, GDCRI Bangalore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2018
Last Updated
November 9, 2018
Sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
Group Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03738514
Brief Title
Comparison of Efficacy of 5% Fluorocalcium Phosphosilicate Dentifrice and Potassium Nitrate Dentifrice on Dentinal Hypersensitivity
Official Title
Comparison Of Efficacy Of Dentifrice Containing 5% Fluorocalcium Phosphosilicate With Dentifrice Containing Potassium Nitrate And Placebo On Dentinal Hypersensitivity: A Triple Masked Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
February 9, 2018 (Actual)
Study Completion Date
February 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
Group Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentinal Hypersensitivity
Keywords
Dentinal Hypersensitivity, Visual Analogue Score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
dentifrice containing 5% fluorocalcium phospho silicate prescribed and VAS score assessed at Baseline, 2 weeks, 6 weeks.
Arm Title
Group 2
Arm Type
Sham Comparator
Arm Description
dentifrice containing 5% potassium nitrate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .
Arm Title
Group 3
Arm Type
Placebo Comparator
Arm Description
dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .
Intervention Type
Other
Intervention Name(s)
5% fluorocalcium phosphosilicate dentifrice
Intervention Description
dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks
Intervention Type
Other
Intervention Name(s)
5% potassium nitrate dentifrice
Intervention Description
5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo dentrifice
Intervention Description
placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks
Primary Outcome Measure Information:
Title
Visual Analogue Scale score for Dentinal Hypersensitivity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avani R Pradeep, MDS
Organizational Affiliation
GDCRI, Bangalore, INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontics, GDCRI Bangalore
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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