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

Primary Purpose

Plaque, Dental

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Water Jet
Manual toothbrush
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plaque, Dental

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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: 1. Special Health Care Needs (SHCN) patients.

Sites / Locations

  • Faculty of Dentistry, Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Water Jet

Manual toothbrush

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in Orthodontic Plaque Index
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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
October 22, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT06098976
Brief Title
The Effectiveness of the Water Jet Device in Removing Dental Plaque Around Orthodontic Braces in Adolescents
Official Title
Dental Plaque Removal Around Orthodontic Braces in Adolescents by Water Jet Device Versus Manual Toothbrush: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 25, 2022 (Actual)
Primary Completion Date
January 22, 2023 (Actual)
Study Completion Date
January 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water Jet
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual toothbrush
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Water Jet
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Manual toothbrush
Intervention Description
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 Outcome Measure Information:
Title
Change in Orthodontic Plaque Index
Description
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.
Time Frame
First assessment time: one day before the commencement of the trial. Second assessment time: four months after the commencement of orthodontic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 1. Special Health Care Needs (SHCN) patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nada Bshara, DDS MSc PhD
Organizational Affiliation
gmmn2012@gmail.com
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Damascus University
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30096429
Citation
Sun F, Ahmed A, Wang L, Dong M, Niu W. Comparison of oral microbiota in orthodontic patients and healthy individuals. Microb Pathog. 2018 Oct;123:473-477. doi: 10.1016/j.micpath.2018.08.011. Epub 2018 Aug 8.
Results Reference
background
PubMed Identifier
14580027
Citation
Hohoff A, Stamm T, Kuhne N, Wiechmann D, Haufe S, Lippold C, Ehmer U. Effects of a mechanical interdental cleaning device on oral hygiene in patients with lingual brackets. Angle Orthod. 2003 Oct;73(5):579-87. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
Results Reference
background
PubMed Identifier
31700567
Citation
Mazzoleni S, De Stefani A, Bordin C, Balasso P, Bruno G, Gracco A. Dental water jet efficacy in the plaque control of orthodontic patients wearing fixed appliance: A randomized controlled trial. J Clin Exp Dent. 2019 Nov 1;11(11):e957-e963. doi: 10.4317/jced.55411. eCollection 2019 Nov.
Results Reference
background
PubMed Identifier
32115117
Citation
Ko-Adams C, Cioffi I, Dufour D, Nainar SMH, Levesque CM, Gong SG. Short-term effects of fixed orthodontic appliance on concentrations of mutans streptococci and persister cells in adolescents. Am J Orthod Dentofacial Orthop. 2020 Mar;157(3):385-391. doi: 10.1016/j.ajodo.2019.04.033.
Results Reference
background
PubMed Identifier
27489605
Citation
Lopatiene K, Borisovaite M, Lapenaite E. Prevention and Treatment of White Spot Lesions During and After Treatment with Fixed Orthodontic Appliances: a Systematic Literature Review. J Oral Maxillofac Res. 2016 Jun 30;7(2):e1. doi: 10.5037/jomr.2016.7201. eCollection 2016 Apr-Jun.
Results Reference
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The Effectiveness of the Water Jet Device in Removing Dental Plaque Around Orthodontic Braces in Adolescents

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