Clinical trial NCT06098976: 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
Overall status: COMPLETED
Phase: NA
Conditions: Plaque, Dental
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Orthodontic Plaque Index
timeFrame: First assessment time: one day before the commencement of the trial. Second assessment time: four months after the commencement of orthodontic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Faculty of Dentistry, Damascus University
Study officials:
affiliation: gmmn2012@gmail.com
name: Nada Bshara, DDS MSc PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.