The Effectiveness of the Water Jet Device in Removing Dental Plaque Around Orthodontic Braces in Adolescents

October 22, 2023 updated by: Damascus University

Dental Plaque Removal Around Orthodontic Braces in Adolescents by Water Jet Device Versus Manual Toothbrush: A Randomized Controlled Trial

The aim of this study was to evaluate the effectiveness of the water jet in removing dental plaque around the orthodontic braces in adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this randomized controlled trial was to evaluate the effectiveness of the water jet in removing dental plaque around the orthodontic braces compared to manual toothbrush in adolescents. The null hypothesis was that no significant difference would be noted between the Water Jet and manual toothbrush in removing dental plaque around the orthodontic braces. Such studies provide another dental care tools for maintaining oral hygiene among orthodontic patients.

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:

  1. Healthy children.
  2. Children aged 11 to 15 years.
  3. Children who did not receive any fluoride treatment in the dental clinic.
  4. Patients who had orthodontic braces at least on the anterior segment of the upper and lower jaws.

Exclusion Criteria:

1. Special Health Care Needs (SHCN) patients.

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
Experimental: Water Jet
The patients were taught how to clean their teeth with the Water Jet device (Water Jet, JollyDent, Damascus, Syria) before starting the dental cleaning procedures. Special heads for patients undergoing orthodontic treatment provided by the company were used with each device. The patient applied the Water Jet device on each tooth separately for 10 seconds starting from the upper jaw to the lower jaw.
Device: Water Jet
The water jet works by directing a stream of water towards the gap between your teeth. The stream of water helps to loosen and remove plaque and food particles stuck in this area.
Active Comparator: Manual toothbrush
Manual toothbrush: The patients were taught to use the modified vertical method, and the patient brushed the teeth of the upper and lower jaws using traditional toothbrushes (Diamond, JolleyDent, Damascus, Syria), and anti-plaque toothpaste (Elgydium, UniPharma Co., Ltd, Ashrafiyat Sahnaya, Syria).
Device: Manual toothbrush
Manual toothbrush: The patients were taught to use the modified vertical method, and the patient brushed the teeth of the upper and lower jaws using traditional toothbrushes (Diamond, JolleyDent, Damascus, Syria), and anti-plaque toothpaste (Elgydium, UniPharma Co., Ltd, Ashrafiyat Sahnaya, Syria).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Orthodontic Plaque Index
Time Frame: First assessment time: one day before the commencement of the trial. Second assessment time: four months after the commencement of orthodontic treatment

The plaque accumulation is measured using the Orthodontic Plaque Index (OPI) Dental plaque is going to be disclosed using a disclosing solution (Mira-2-Ton®, Hager & Werken GmbH & Co. KG, Duisburg, Germany) after the last brushing then immediately after cleansing.

The dentition is divided into sextants, and the highest score of plaque accumulation per sextant is going to be assigned. The OPI for a patient was determined by calculating the average.
First assessment time: one day before the commencement of the trial. Second assessment time: four months after the commencement of orthodontic treatment

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Study Chair: Nada Bshara, DDS MSc PhD, gmmn2012@gmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 25, 2022

Primary Completion (Actual)

January 22, 2023

Study Completion (Actual)

January 22, 2023

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-02-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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