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

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ClinicalTrials.gov Identifier: NCT03741309
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Group Pharma
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate and to a Placebo on Dentinal Hypersensitivity : a Randomized Clinical Trial
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : February 16, 2018
Actual Study Completion Date : February 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Calcium

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

Sham Comparator: Group II
dentifrice containing Calcium sodium phosphosilicate prescribed and VAS score assessed at Baseline, 2weeks, 6 weeks .
Other: Calcium sodium phosphosilicate
Calcium sodium phosphosilicatand VAS score assessed at Baseline, 2weeks, 6 weeks.

Placebo Comparator: Group III
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.




Primary Outcome Measures :
  1. Visual Analogue Scale score for Dentinal Hypersensitivity [ Time Frame: Change in VAS score from Baseline to 6 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.



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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.

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): NCT03741309


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

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Responsible Party: Dr. A R Pradeep, Head and Professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT03741309     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/Ph.D/5/2016-2017N
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 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 analog scale

Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents