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

NCT ID: NCT02738541

Last Updated: 2016-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

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

Group Type ACTIVE_COMPARATOR

DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE

Intervention Type DRUG

DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS

Group 2

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

Group Type PLACEBO_COMPARATOR

PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE

Intervention Type DRUG

PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS

Interventions

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DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE

DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS

Intervention Type DRUG

PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE

PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS

Intervention Type DRUG

Other Intervention Names

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XTAR

Eligibility Criteria

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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 .
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role lead

Responsible Party

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Dr. A R Pradeep

Professor & Head, Department of Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Government Dental College and Research Institute

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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GDCRI/ACM/PG/PhD/2/2014-2015FN

Identifier Type: -

Identifier Source: org_study_id

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