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Clinical Trials/CTRI/2025/03/083579
CTRI/2025/03/083579Not yet recruitingNot Applicable

Comparison of the effectiveness of two different toothpastes formulation in the reduction of plaque and gingival inflammation among 6-12 years old children -A randomized controlled trial

self1 site in 1 country60 target enrollmentStarted: April 30, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
self
Enrollment
60
Locations
1
Primary Endpoint
improvement in Plaque , gingival bleeding and ph
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The study is a randomised , double blind, parallel group, multicentre trial, comparing the efficacy of two toothpastes formulations with controlled group in plaque  control and gingival bleeding in children from aged 6years to 12 years. The salivary ph of this children will also be assessed. The primary outcome measures the antiplaque efficacy , reduction in gingival bleeding and salivary ph. The evaluation will be assessed in baseline, 7thday, 21st days.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Investigator Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Healthy participants without any systemic condition.
  • •participants without any oral prophylaxis procedure from 6 months.

Exclusion Criteria

  • •medically compromised children Periodontally compromised children.

Outcomes

Primary Outcomes

improvement in Plaque , gingival bleeding and ph

Time Frame: improvement in Plaque , gingival bleeding and ph in baseline , 4th week, 8thweek

Secondary Outcomes

  • improvement in salivary ph(baseline , 7thday , 21st day.)

Investigators

Sponsor
self
Sponsor Class
Research institution and hospital

Study Sites (1)

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