Evaluation of the Effectiveness of Different Toothbrushes in Children

December 15, 2023 updated by: Marmara University

Evaluating the Effectiveness of Different Toothbrushes in Children

Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared.

Study design: Experimental study

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush.

Subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. Parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. Clinical examination of each participant was carried out by the principal investigator. Assessments were done pre- and post-brushing using the "Silness and Löe Plaque Index" (PI), Gingival Index (GI), and the Simplified Oral Hygiene Index (OHI-S). Plaque indices were expressed as means and standard deviations (SD). Within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p < 0.05 was considered statistically significant.

Study Type

Interventional

Enrollment (Estimated)

120

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
    • İstanbul
      • Maltepe, İstanbul, Turkey
        • Recruiting
        • Marmara University
        • Contact:
        • Principal Investigator:
          • Betül Kargül, Prof.
        • Sub-Investigator:
          • Başak Durmuş, Prof.
        • Sub-Investigator:
          • Ecem Akbeyaz Şivet, Dr.
        • Sub-Investigator:
          • Hilal Niyazoğlu, Dt.
        • Sub-Investigator:
          • Neslihan Atmaca, Dt.

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy children aged 2-12.
  • Children without systemic disease or developmental dental anomalies.
  • Children not undergoing orthodontic treatment.
  • Children with no decay on the labial surfaces of upper anterior incisors.
  • Patients or their parents accepting participation in the treatment.

Exclusion Criteria:

  • Children with decay on the labial surfaces of upper anterior incisors.
  • Children undergoing orthodontic treatment.
  • Children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control group
A control group will be formed using a manual brush with a classic head.
Device: standart manual toothbrush
Device on plaque removal efficacy
Experimental: study group
A study group will be formed using a 360-degree bristle brush.
Device: 360 degree toothbrush
Device on plaque removal efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
Time Frame: 2 weeks
Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.
2 weeks

Collaborators and Investigators

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

Sponsor

Marmara 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)

November 20, 2023

Primary Completion (Estimated)

December 20, 2023

Study Completion (Estimated)

January 20, 2024

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27.11.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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