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

ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738541
• Other study ID #: GDCRI/ACM/PG/PhD/2/2014-2015FN
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2016
• Last updated: April 13, 2016
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS
• Calculi

Intervention

Drug:
• DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE
DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS
• PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE
PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	simplied calulus index.		Baseline to 6 months	No