NCT02738541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

April 11, 2016

Last Update Submit

April 13, 2016

Conditions

ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS

Outcome Measures

Primary Outcomes (1)

  • simplied calulus index.

    Baseline to 6 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

PLACEBO COMPARATOR

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

Drug: PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE

Interventions

DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATEDRUG

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

Also known as: XTAR
Group 1
PLACEBO DENTRIFICE WITHOUT PROPHOSPHATEDRUG

PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS

Group 2

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Head, Department of Periodontology

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 14, 2016

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

IN(1)