NCT06098976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

March 20, 2023

Last Update Submit

October 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Water Jet

EXPERIMENTAL

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

Manual toothbrush

ACTIVE COMPARATOR

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

Interventions

Water JetDEVICE

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.

Water Jet

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).

Manual toothbrush

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • \. Special Health Care Needs (SHCN) patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Damascus University

Damascus, Syria

Location

Related Publications (5)

  • 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.

    PMID: 30096429BACKGROUND
  • 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.

    PMID: 14580027BACKGROUND
  • 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.

    PMID: 31700567BACKGROUND
  • 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.

    PMID: 32115117BACKGROUND
  • 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.

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Nada Bshara, DDS MSc PhD

    gmmn2012@gmail.com

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

October 25, 2023

Study Start

September 25, 2022

Primary Completion

January 22, 2023

Study Completion

January 22, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations