Plaque Removal by Triple-Headed Manual Toothbrush

January 27, 2025 updated by: Didem OZKAL EMINOGLU, Ataturk University

Evaluation of Plaque Removal by Triple-Headed Manual Toothbrush: A Randomized Controlled Clinical Trial

This randomized controlled trial aimed to determine the effectiveness of a plaque removal by triple-headed manual toothbrush by comparing changes in Rustogi Modifiye Navy Plaque Index.

Participants will be divided into two groups and will be made to brush with different designed toothbrushes.

The researchers will compare the plaque removal efficiency of the brushes by comparing the changes in the plaque index of the intervention and control groups before and after brushing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

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

  • Turkey
      • Erzurum, Turkey, 25240_
        • Ataturk University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age ranging from 18-60 years;
  • a minimum of 12 teeth;
  • participants were wanted to be right-handers when toothbrushing to standardization.

Exclusion Criteria:

  • Patients with systemic illnesses or conditions,
  • smokers and individuals taking any medication that may affect periodontal health were not included in the study.
  • Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standart Manual Toothbrush (SMB)
Conventional toothbrushing with standart manual toothbrush
Procedure: Toothbrushing with standard manual toothbrush
Toothbrushing with tstandard manual toothbrush
Experimental: Triple-Headed Manual Toothbrush (3HB)
Toothbrushing with triple-headed manual toothbrush
Procedure: Toothbrushing with triple-headed manual toothbrush
Toothbrushing with triple-headed manual toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rustogi Modifiye Navy Plaque Index
Time Frame: 1 minute before brushing
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.
1 minute before brushing
Rustogi Modifiye Navy Plaque Index
Time Frame: 1 minute after brushing
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.
1 minute after brushing

Collaborators and Investigators

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

Sponsor

Ataturk University

Investigators

  • Study Director: Didem Özkal Eminoğlu, Ataturk University

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 (Actual)

January 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSA-2023-13318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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