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

Plaque, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098976
• Other study ID #: UDDS-Pedo-02-2023
• Status: Completed
• Phase: N/A
• Start date: September 25, 2022
• Est. completion date: January 22, 2023

Study information

• Verified date: October 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 22, 2023
• Est. primary completion date: January 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Plaque, Dental

Intervention

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.
• 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).

Locations

Country	Name	City	State
Syrian Arab Republic	Faculty of Dentistry, Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First assessment time: one day before the commencement of the trial. Second assessment time: four months after the commencement of orthodontic treatment