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Completed

NCT Number: NCT06098976

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

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

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Key information

Conditions

Plaque, Dental Dental Deposits Dental Plaque Stomatognathic Diseases Tooth Diseases

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Special Health Care Needs (SHCN) patients.

Treatment and study plan

Water Jet

Device

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.

Manual toothbrush

Device

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).

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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