Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001740189
Ethics application status
Approved
Date submitted
12/09/2019
Date registered
9/12/2019
Date last updated
22/06/2021
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of low level laser in treating anterior open bite
Scientific title
Evaluating the effectiveness of low level laser in improving the early treatment of the skeletal anterior open bite using fixed posterior bite block
Secondary ID [1] 299259 0
None
Universal Trial Number (UTN)
U1111-1240-1083
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior open bite 314398 0
Condition category
Condition code
Oral and Gastrointestinal 312733 312733 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
36 eligible patients with open Anterior bite in 8-10 years old children will be randomly divided into 3 groups:
Posterior bite block with low-level laser, arm 1
Posterior bite block, arm 2
Untreated controlled group, arm 3
The nature of the treatment and the study were explained to the parents, and signed consent was obtained.
Each participant will be assigned to one treatment group.
Cephalometric radiographs were obtained before (T1) and immediately after appliance removal (T2).
In treatment groups, the bite-blocks ( small clear acrylic (plastic) blocks) will be cemented to the teeth until at least an overbite of 1mm was reached and will be followed for 9 months.
The untreated controlled group will be followed for 9 months.
The application of posterior bite block and low-level laser will be done by an experienced investigator and the intervention will be delivered in the faculty of dentistry at Damascus University.
Patients in the laser group received a LLL dose from an 830-nm wavelength Ga-Al-As semiconductor laser device with energy of 4 J/point.
A visual examination will be performed every month after the treatment to identify and assess the anterior open bite.
Intervention code [1] 315549 0
Treatment: Devices
Comparator / control treatment
No treatment group.
Control group
Active

Outcomes
Primary outcome [1] 321371 0
The time that was required to treat anterior open bite.
The measure will be done by an experienced investigators and will be calculated between the period of the application of posterior bite block and an 1 mm of overbite reached.
lateral cephalometric radiographs were studied before the application of the device (T1), (T2) after the Overbite becomes 1 mm.
Timepoint [1] 321371 0
(t1): Baseline, after application of posterior block bite
(t2): 1 mm of overbite reached for a maximum of 2 years,
Secondary outcome [1] 374783 0
Cephalometric evaluation
The measure will be done by an experienced investigators and will be calculated between the period of the application of posterior bite block and an 1mm of over bite reached.
Twenty landmarks were identified on each cephalogram
Lateral cephalometric radiographs were studied before the application of the device (T1), (T2) after the Overbite becomes 1mm,
taken before (T1) and after (T2) treatment. Treatment and
normal growth changes between T1 and T2 were evaluated
by 7 angular and 13 linear measurements
Timepoint [1] 374783 0
(T`1): Before the application of posterior bite block.
(T2): After removing posterior bite block immediately.

Eligibility
Key inclusion criteria
- children between 8 and 10 years of age.
- fully erupted maxillary and mandibular incisors,
- a 1 mm (minimum) anterior open bite,
- free of all systematic and developmental disorders
- no previous orthodontic treatment.
Minimum age
8 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- children with systematic or developmental disorders
- children with bad oral health
- children with previous orthodontic treatment
- children with posterior crossbite

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation for children will be done using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be performed by using SPSS for
Windows release 16.0 (SPSS Inc., Chicago, IL, USA).
Chronological ages and treatment periods of the groups
will be compared with one-way analysis of variance
(ANOVA). Homogeneity of the variances will be tested with
Levene’s test. A paired-sample t test will be used to evaluate
treatment-induced changes within each group. Intergroup
comparisons of the cephalometric measurements will be performed by ANOVA, and the post hoc Tukey test will be used to perform multiple comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2020
Actual
1/01/2020
Date of last participant enrolment
Anticipated
29/02/2020
Actual
29/02/2020
Date of last data collection
Anticipated
1/06/2020
Actual
1/06/2020
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 21856 0
Syrian Arab Republic
State/province [1] 21856 0
Damasucs

Funding & Sponsors
Funding source category [1] 303794 0
University
Name [1] 303794 0
Damascus University
Country [1] 303794 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damasucs University
Address
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
Country
Syrian Arab Republic
Secondary sponsor category [1] 303917 0
None
Name [1] 303917 0
Address [1] 303917 0
Country [1] 303917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304314 0
Ethical and Scientific Committee of dental research, Damascus University,
Ethics committee address [1] 304314 0
Ethics committee country [1] 304314 0
Syrian Arab Republic
Date submitted for ethics approval [1] 304314 0
20/04/2019
Approval date [1] 304314 0
20/05/2019
Ethics approval number [1] 304314 0

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

Contacts
Principal investigator
Name 96502 0
Dr Amjad Hasan
Address 96502 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 96502 0
Syrian Arab Republic
Phone 96502 0
+963988365439
Fax 96502 0
Email 96502 0
[email protected]
Contact person for public queries
Name 96503 0
Amjad Hasan
Address 96503 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 96503 0
Syrian Arab Republic
Phone 96503 0
+963988365439
Fax 96503 0
Email 96503 0
[email protected]
Contact person for scientific queries
Name 96504 0
Amjad hasan
Address 96504 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 96504 0
Syrian Arab Republic
Phone 96504 0
+963988365439
Fax 96504 0
+963988365439
Email 96504 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
undecided IPD sharing reason


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4734Study protocol  [email protected]
4735Informed consent form  [email protected]
4736Ethical approval  [email protected]



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.