Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000524695
Ethics application status
Approved
Date submitted
3/03/2023
Date registered
19/05/2023
Date last updated
19/05/2023
Date data sharing statement initially provided
19/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dental plaque removal around orthodontic braces in adolescents
Scientific title
Dental Water Jet efficacy in plaque removal around orthodontic braces in adolescents: A randomized controlled trial
Secondary ID [1] 309125 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 329220 0
Condition category
Condition code
Infection 326180 326180 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 326506 326506 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1; the dental Water Jet. The patients were taught by a dentist how to clean their teeth with the Water Jet device before starting the dental cleaning procedures at the baseline visit. 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. Cleaning procedure was done for one time. Participants use a conventional toothbrush with anti-plaque toothpaste.
Group 2; the orthodontic toothbrush. The patients were taught to use the modified vertical method, and the patient brushed the teeth of the upper and lower jaws using orthodontic toothbrushes, and anti-plaque toothpaste.
Intervention code [1] 325575 0
Treatment: Devices
Comparator / control treatment
Control group; conventional 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 for one time, and anti-plaque toothpaste.
Control group
Active

Outcomes
Primary outcome [1] 334054 0
The level of oral hygiene was assessed by a dental examination in patients undergoing fixed orthodontic treatment. It was assessed according to Orthodontic Plaque Score and there was severe plaque accumulation.
Timepoint [1] 334054 0
After brushing.
Secondary outcome [1] 419202 0
The dental plaque accumulation was assessed using the Orthodontic Plaque Index (OPI).
Timepoint [1] 419202 0
after brushing

Eligibility
Key inclusion criteria
1. Healthy children.
2. Children aged 11 to 15 years.
3. Patients undergoing fixed orthodontic treatment
Minimum age
11 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Special health care needs (SHCN) patients.
2. Patients with low manual dexterity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study participants were randomly allocated into three groups using randomization online software; http://www.randomization.com.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study participants were randomly allocated into three groups using randomization online software; http://www.randomization.com.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/10/2022
Date of last participant enrolment
Anticipated
Actual
15/02/2023
Date of last data collection
Anticipated
Actual
15/02/2023
Sample size
Target
45
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 25308 0
Syrian Arab Republic
State/province [1] 25308 0
Damascus

Funding & Sponsors
Funding source category [1] 313328 0
University
Name [1] 313328 0
Damascus University
Country [1] 313328 0
Syrian Arab Republic
Primary sponsor type
Individual
Name
Mawia Karkoutly
Address
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 315072 0
Individual
Name [1] 315072 0
Nada Bshara
Address [1] 315072 0
Nada Bshara, Damascus University, Mazzeh Highway, Damascus, Syria
Country [1] 315072 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312551 0
Damascus University
Ethics committee address [1] 312551 0
Ethics committee country [1] 312551 0
Syrian Arab Republic
Date submitted for ethics approval [1] 312551 0
Approval date [1] 312551 0
28/09/2022
Ethics approval number [1] 312551 0
2358

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125058 0
Dr Mawia Karkoutly
Address 125058 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 125058 0
Syrian Arab Republic
Phone 125058 0
+963992647528
Fax 125058 0
Email 125058 0
[email protected]
Contact person for public queries
Name 125059 0
Mawia Karkoutly
Address 125059 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 125059 0
Syrian Arab Republic
Phone 125059 0
+963992647528
Fax 125059 0
Email 125059 0
[email protected]
Contact person for scientific queries
Name 125060 0
Mawia Karkoutly
Address 125060 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 125060 0
Syrian Arab Republic
Phone 125060 0
+963992647528
Fax 125060 0
Email 125060 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Reviewers/Editors

Conditions for requesting access:
• -

What individual participant data might be shared?
• Demographic data

What types of analyses could be done with individual participant data?
• Descriptive

When can requests for individual participant data be made (start and end dates)?
From:
After the requesting date and available for 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• via website (https://zenodo.org/)

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.