U Shaped Toothbrush in Removing Plaque in Children

May 23, 2024 updated by: Damascus University

Evaluating the Effectiveness of a U-shaped Toothbrush in Removing Plaque In Pre-school Children

The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.

Children accepted in the study will be randomly divided into two groups:

The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the effectiveness U-shaped toothbrush in removing plaque and improving oral health. Children were randomly assigned to one of the following groups:

Group A: children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.

Group B: children in this group will use a U-shaped brush first to clean their teeth then will use a traditional brush later The plaque will be assessed by a blinded evaluator using the Turesky Modified Quigley Hein index (TMQH) in both groups at 4 different times(T0): before brush (T1): after brush (T2): a week after use (T3): a month of use The toothbrush will be changed after one month of use.

Study Type

Interventional

Enrollment (Actual)

30

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

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:

Medically free children. Complete temporary occlusion (no missing temporary teeth). The parents' approval for the child to enter the study.

Exclusion Criteria:

Children with limited ability to communicate. Children with motor disabilities.

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: Traditional toothbrush group
Children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.
Other: Traditional toothbrush group
Children in this group will use a traditional brush with a traditional toothpaste first to clean their teeth then after 30 days they will use a U shaped brush with a traditional toothpaste for another 30 days.
Experimental: U shaped toothbrush group
children in this group will use a U-shaped brush first to clean their teeth then will use traditional brush later
Other: U shaped toothbrush group
Children in this group will use a U shaped brush with a traditional toothpaste first to clean their teeth then after 30 days they will use a traditional brush with a traditional toothpaste for another 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing in plaque index
Time Frame: Plaque index will be measured before brushing (T0) and after brushing in both groups on the first day (T1), a week after use (T2), and after a month of use (T3) with each toothbrush
0 No plaque,1 Isolated flecks of plaque at the gingival margin, 2 A continuous band of plaque up to 1mm at the gingival margin, 3 Plaque greater than 1mm in width and covering up to one third of the tooth surface, 4 Plaque covering from one thirds to two thirds of the tooth surface, and 5 Plaque covering more than two thirds of the tooth surface
Plaque index will be measured before brushing (T0) and after brushing in both groups on the first day (T1), a week after use (T2), and after a month of use (T3) with each toothbrush

Collaborators and Investigators

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

Sponsor

Damascus 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)

February 1, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-02-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

only with contacting the main researcher

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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