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Anti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers

Sponsor
Government Dental College and Research Institute, Bangalore (Other)
Overall Status
Completed
CT.gov ID
NCT02738541
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
6
Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to determine the anti-calculus effect of dentrifice containing 5% sodium pyrophosphate and potassium pyrophosphate in a triple-mask placebo controlled randomized clinical trial.

Condition or Disease Intervention/Treatment Phase
  • Drug: DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE
  • Drug: PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of Anti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1

DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS PRESCRIBED AND SUBJECTS WERE EVALUATED AT 3MONTH AND 6 MONTHS

Drug: DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE
DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS
Other Names:
  • XTAR

    		•
    Placebo Comparator: Group 2

    PLACEBO DENTRIFICE WITHOUT PYROPHOSPATE WAS PRESCRIBED AND SUBJECTS WERE EVALUATED AT 3MONTH AND 6 MONTHS

    Drug: PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE
    PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS

    Outcome Measures

    Primary Outcome Measures

    1. simplied calulus index. [Baseline to 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Age group 15-30 years.

    2. Subjects who have not received periodontal therapy within preceding 1year.

    3. Heavy calculus formers with simplified calculus index score 1.5-3 .

    Exclusion Criteria:

    1. Age group 15-30 years.

    2. Subjects who have not received periodontal therapy within preceding 1year.

    3. Heavy calculus formers with simplified calculus index score 1.5-3 .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Government Dental College and Research Institute Bangalore Karnataka India 560002

    Sponsors and Collaborators

    • Government Dental College and Research Institute, Bangalore

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. A R Pradeep, Professor & Head, Department of Periodontology, Government Dental College and Research Institute, Bangalore
    ClinicalTrials.gov Identifier:
    NCT02738541
    Other Study ID Numbers:
    • GDCRI/ACM/PG/PhD/2/2014-2015FN
    First Posted:
    Apr 14, 2016
    Last Update Posted:
    Apr 14, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Calculi

    Study Results

    No Results Posted as of Apr 14, 2016