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

April 13, 2016 updated by: Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Government Dental College and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
simplied calulus index.
Time Frame: Baseline to 6 months
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Government Dental College and Research Institute, Bangalore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDCRI/ACM/PG/PhD/2/2014-2015FN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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