Back to resultsAnti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers
Primary Purpose
ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE
PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE
Sponsored by
About this trial
This is an interventional treatment trial for ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS
Eligibility Criteria
Inclusion Criteria:
- Age group 15-30 years.
- Subjects who have not received periodontal therapy within preceding 1year.
- Heavy calculus formers with simplified calculus index score 1.5-3 .
Exclusion Criteria:
- Age group 15-30 years.
- Subjects who have not received periodontal therapy within preceding 1year.
- Heavy calculus formers with simplified calculus index score 1.5-3 .
Sites / Locations
- Government Dental College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS PRESCRIBED AND SUBJECTS WERE EVALUATED AT 3MONTH AND 6 MONTHS
PLACEBO DENTRIFICE WITHOUT PYROPHOSPATE WAS PRESCRIBED AND SUBJECTS WERE EVALUATED AT 3MONTH AND 6 MONTHS
Outcomes
Primary Outcome Measures
simplied calulus index.
Secondary Outcome Measures
Full Information
NCT ID
NCT02738541
First Posted
April 11, 2016
Last Updated
April 13, 2016
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02738541
Brief Title
Anti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers
Official Title
Evaluation of Anti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS PRESCRIBED AND SUBJECTS WERE EVALUATED AT 3MONTH AND 6 MONTHS
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
PLACEBO DENTRIFICE WITHOUT PYROPHOSPATE WAS PRESCRIBED AND SUBJECTS WERE EVALUATED AT 3MONTH AND 6 MONTHS
Intervention Type
Drug
Intervention Name(s)
DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE
Other Intervention Name(s)
XTAR
Intervention Description
DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS
Intervention Type
Drug
Intervention Name(s)
PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE
Intervention Description
PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS
Primary Outcome Measure Information:
Title
simplied calulus index.
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age group 15-30 years.
Subjects who have not received periodontal therapy within preceding 1year.
Heavy calculus formers with simplified calculus index score 1.5-3 .
Exclusion Criteria:
Age group 15-30 years.
Subjects who have not received periodontal therapy within preceding 1year.
Heavy calculus formers with simplified calculus index score 1.5-3 .
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
12. IPD Sharing Statement
Learn more about this trial
Anti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers
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