Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000427976
Ethics application status
Approved
Date submitted
25/01/2020
Date registered
31/03/2020
Date last updated
30/07/2021
Date data sharing statement initially provided
31/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of vibration on accelerating orthodontic treatment
Scientific title
Evaluation of high frequency vibration effect on orthodontic tooth movement in patients requiring canine retraction
Secondary ID [1] 300303 0
Nil known
Universal Trial Number (UTN)
U1111-1246-5947
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the rate of orthodontic tooth movement 315903 0
Condition category
Condition code
Oral and Gastrointestinal 314175 314175 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
in order to investigate accelerating tooth movement ,participant will be instructed to use an electric toothbrush with vibrating head (90 HZ) at home on the buccal side of the experimental upper canine for 5 minutes 3 times a day for 3 months. The adherence will be monitored through mobile phone application.
Intervention code [1] 316578 0
Treatment: Devices
Comparator / control treatment
the study is a split mouth design
the control side will receive regular orthodontic treatment without using any mean of acceleration
Control group
Active

Outcomes
Primary outcome [1] 322556 0
the difference in the rate of canine retraction between intervention and control sides
the measurements will be carried out on the digital photographs of the casts using AudaxCeph
Timepoint [1] 322556 0
to create orthodontic casts an alginate impression will be taken immediately before starting canine retraction and every 30 days.
Secondary outcome [1] 378924 0
Nil
Timepoint [1] 378924 0
Nil

Eligibility
Key inclusion criteria
patients seeking orthodontic treatment and requiring the extraction of upper first premolars with good oral hygiene
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
any medical problems that affect orthodontic tooth movement
missing any permanent maxillary teeth
poor oral hygiene

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2020
Actual
27/04/2020
Date of last participant enrolment
Anticipated
Actual
25/05/2020
Date of last data collection
Anticipated
Actual
1/03/2021
Sample size
Target
20
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 22238 0
Syrian Arab Republic
State/province [1] 22238 0
Damascus

Funding & Sponsors
Funding source category [1] 304724 0
University
Name [1] 304724 0
Damascus University
Country [1] 304724 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria PO Box 30621
Country
Syrian Arab Republic
Secondary sponsor category [1] 305039 0
None
Name [1] 305039 0
Address [1] 305039 0
Country [1] 305039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305150 0
Ethical and scientific committee of dental research of Damascus University
Ethics committee address [1] 305150 0
Ethics committee country [1] 305150 0
Syrian Arab Republic
Date submitted for ethics approval [1] 305150 0
11/04/2018
Approval date [1] 305150 0
07/05/2018
Ethics approval number [1] 305150 0

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

Contacts
Principal investigator
Name 99406 0
Dr Nour Bustati
Address 99406 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria PO Box 30621
Country 99406 0
Syrian Arab Republic
Phone 99406 0
+963992810651
Fax 99406 0
Email 99406 0
[email protected]
Contact person for public queries
Name 99407 0
Nour Bustati
Address 99407 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria PO Box 30621
Country 99407 0
Syrian Arab Republic
Phone 99407 0
+963992810651
Fax 99407 0
Email 99407 0
[email protected]
Contact person for scientific queries
Name 99408 0
Nour Bustati
Address 99408 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria PO Box 30621
Country 99408 0
Syrian Arab Republic
Phone 99408 0
+963992810651
Fax 99408 0
Email 99408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.