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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738514
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : November 13, 2018
Sponsor:
Collaborator:
Group Pharma
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dentinal Hypersensitivity Other: 5% fluorocalcium phosphosilicate dentifrice Other: 5% potassium nitrate dentifrice Other: Placebo dentrifice Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 22, 2017
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Potassium

Arms and Interventions
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Arm Intervention/treatment
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
dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks
Sham Comparator: Group 2
dentifrice containing 5% potassium nitrate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .
 Other: 5% potassium nitrate dentifrice
5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.
Placebo Comparator: Group 3
dentifrice without the active ingredient prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .
 Other: Placebo dentrifice
placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogue Scale score for Dentinal Hypersensitivity [ Time Frame: Change in VAS score from Baseline to 12 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738514


Locations
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India
Department of Periodontics, GDCRI Bangalore
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore
Group Pharma
Investigators
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Principal Investigator: Avani R Pradeep, MDS GDCRI, Bangalore, INDIA
More Information
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Responsible Party: Dr. A R Pradeep, Head and Professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT03738514    
Other Study ID Numbers: GDCRI/ACM/PG/Ph.D/5/2016-2017
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:
Dentinal Hypersensitivity
Visual Analogue Score
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases