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Trial registered on ANZCTR


Registration number
ACTRN12620000495921
Ethics application status
Approved
Date submitted
25/10/2019
Date registered
20/04/2020
Date last updated
20/04/2020
Date data sharing statement initially provided
20/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of root resorption in two types of inner braces by three dimensional radiograph.
Scientific title
Volumetric evaluation of root resorption in single and double slots lingual orthodontic appliances by aid of Cone Beam Computed Tomography and VR Mesh
(A comparative study).
Secondary ID [1] 299627 0
None
Universal Trial Number (UTN)
U1111-1145-4130
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Root resorption 314944 0
Condition category
Condition code
Oral and Gastrointestinal 313291 313291 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the cases selected from patient's came to the college of dentistry in Sulaymaniyah seeking orthodontic treatment according to our inclusion criteria for the affected teeth and the type of malocclusion. We prescribed all the procedures of the work for them and after they agreed they signed up an acceptance letter we prepared it before which describe the risks and difficulties of the work. When we finished all the pre orthodontic preparations we should start bondings of two different 2D lingual bracket systems (single slot DMC and double slots Duet type) on the two different group of patients with equal numbers of male and females. The indirect (bonding by equalized specific thikness) BEST technique will be used for setting up the brackets on the cast of the patient. After setting up the brackets with perfect torque and angulations we will transfer the brackets into patients mouth by aid of special trays that holding the brackets accurately on to the teeth and then we will bond them by composite.
In our work we will try to compare the volume of resorption in pre and post orthodontic treatment through Cone Beam Computed Tomography (CBCT) with restricted filled of view and by the use of Materialise Interactive Medical Image Control System (MIMICS) and VirtualGrid, Bellevue City, WA (VR Mesh) softwares we will compare the amount of tooth movement between the two groups. We should contact all the patients in the university dental clinic for diagnosis, treatment plan and follow up of the patient under supervision of my supervisors. We select the patients randomly from those who visited our college of Dentistry in Sulaymaniyah seeking the treatment of irregularities in their teeth and they prefer esthetic appliances of Dentistry in Sulaymaniyah when they fit our criteria. The first bonding of the brackets take 30-40 minutes but the follow up visits may be 15 minutes duration every 2-3 weeks along the duration of about 1 year.
Intervention code [1] 315900 0
Treatment: Devices
Comparator / control treatment
I will compare two different bracket systems (single and double slots) in their volume of root resorption and we regards the single slot system as a reference bracket system.
Control group
Active

Outcomes
Primary outcome [1] 321784 0
Measuring the volume of root resorption by VR Mesh and 3 Matic softwares after segmentation of single anterior tooth from patient's CBCT that taken by the same device which will be used later in research with the same criteria so we compare pre and post orthodontic CBCT.
Timepoint [1] 321784 0
All patients have 2 sets of CBCT pre and post orthodontic treatments which mean after complete active treatment procedure for about one year.
Secondary outcome [1] 376193 0
Root resorption at the end of treatment compared with amount of tooth movement through VR Mesh softwares by comparing the distance that tooth moves during retraction with the volume of root resorption between the patient to see if there any relation between how long the tooth move to the amount of the root resorption.
Timepoint [1] 376193 0
There are two measurements in two different intervals before and after orthodontic treatment in two different lingual orthodontic techniques (which mean after complete active treatment procedure for about one year).
Secondary outcome [2] 376194 0
The amount of tooth movement in two different lingual bracket systems by super-positioning the two arches (pre and post treatment) from CBCT by VR Mesh softwares.
Timepoint [2] 376194 0
Measured through the pre and post orthodontic treatment CBCT by VR Mesh software (which mean after complete active treatment procedure for about one year).

Eligibility
Key inclusion criteria
1. Adult patients of ages between 18-25 with Angle Class I or half cusp class II molar relation-ship, class II incisor relationship with upper anterior crowding (5-7 mm) that need two first premolar extraction.
2. Not require change in the posterior relationship.
3. No need for arch expansion or molar distalization.
4. Normal lower dental arch without dental irregularities.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with previous evidence of root resorption.
2. Total cusp class II or class III molar relationship.
3. Overjet greater than (6mm).
4. History of trauma or impacted canines.
5. Previous orthodontic treatment.
6. Systemic diseases on medication and pregnant women.
7. Patients with poor oral hygiene, endodonticly treated tooth and / or dental anomalies of a number of teeth.
the two premolar extraction planed to create space for mal aligned teeth.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not available
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not available
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A total number of 36 patients selected to be treated and investigated by the 2 systems of lingual orthodontic appliance (STb and Duet) and then they randomly divided between the 2 systems (by giving odd or eve number to each member in the sample then select the number randomly). lastly we have 18 males and 18 females.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
3/09/2019
Date of last participant enrolment
Anticipated
Actual
23/11/2019
Date of last data collection
Anticipated
5/01/2021
Actual
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 21965 0
Iraq
State/province [1] 21965 0
Sulaymaniyah

Funding & Sponsors
Funding source category [1] 304104 0
University
Name [1] 304104 0
University of Sulaimani /College of Dentistry
Country [1] 304104 0
Iraq
Primary sponsor type
University
Name
University of Sulaimani /College of Dentistry
Address
Iraq/ Sulaymaniyah/ Mitterrand Street
postcode 46001
Country
Iraq
Secondary sponsor category [1] 304714 0
None
Name [1] 304714 0
Address [1] 304714 0
Country [1] 304714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304592 0
1) Assisstant prof. Fadil Abdulla Karim the head of the committee of College of Dentistry University of Sulaymaniy
Ethics committee address [1] 304592 0
Ethics committee country [1] 304592 0
Iraq
Date submitted for ethics approval [1] 304592 0
03/03/2019
Approval date [1] 304592 0
12/03/2019
Ethics approval number [1] 304592 0

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

Contacts
Principal investigator
Name 97510 0
A/Prof Tara Ali Rasheed
Address 97510 0
University of Sulaimani/College of Dentistry
Mitterrand Street.
Sulaimani/Iraq P.O.Box 374
Country 97510 0
Iraq
Phone 97510 0
+9647701528496
Fax 97510 0
Email 97510 0
tara.rasheed@univsul.edu.iq
Contact person for public queries
Name 97511 0
Aram Ahmed Mohammed
Address 97511 0
Iraq/ Sulaymaniyah
Sulaymaniyah teaching hospital
Mitterrand Street.
Postcode 46001
P.O.Box Sulaymaniyah/Iraq 374
Country 97511 0
Iraq
Phone 97511 0
+9647701525394
Fax 97511 0
Email 97511 0
kakarash1967@hotmail.com
Contact person for scientific queries
Name 97512 0
Aras Maruf Rauf
Address 97512 0
University of Sulaimani/College of Dentistry
Mitterrand Street
Postcode 46001
Country 97512 0
Iraq
Phone 97512 0
+9647702419930
Fax 97512 0
Email 97512 0
aras.rauf@univsul.edu.iq

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The datas which evaluating the volume of root resorption through three dimension assessment.
When will data be available (start and end dates)?
The datas will be available after two years from the date of publications.
Available to whom?
Available to who make research in this feild.
Available for what types of analyses?
Available for the comparison purposes.
How or where can data be obtained?
tara.rasheed@univsul.edu.iq


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5470Statistical analysis plan  tara.rasheed@univsul.edu.iq 378613-(Uploaded-25-10-2019-22-53-06)-Study-related document.docx
6248Informed consent form  tara.rasheed@univsul.edu.iq 378613-(Uploaded-19-12-2019-22-56-33)-Study-related document.docx



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.