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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]

None

Universal Trial Number (UTN)

U1111-1145-4130

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Root resorption

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Iraq

State/province [1]

Sulaymaniyah

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sulaimani /College of Dentistry

Country [1]

Iraq

Primary sponsor type

University

Name

University of Sulaimani /College of Dentistry

Country

Iraq

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

1) Assisstant prof. Fadil Abdulla Karim the head of the committee of College of Dentistry University of Sulaymaniy

Ethics committee address [1]

University of Sulaimani /College of Dentistry/postcode 46001
fadil.kareem@univsul.edu.iq

Ethics committee country [1]

Iraq

Date submitted for ethics approval [1]

03/03/2019

Approval date [1]

12/03/2019

Ethics approval number [1]

Summary

Brief summary

This study will be done on Kurdish patients aged between 18-25 in the College of Dentistry University of Sulaimani to find out the presence of root resorption after the correction of upper anterior crowding by two different types of 2D lingual orthodontic bracket systems (single and double slots). Volumetric root planned to be assessed by evaluating the patients CBCT before and after completion of orthodontic treatment phases in the same manner by applying MIMICS (Materialise NV, Leuven, Belgium) which is an acronym for Materialise Interactive Medical Image Control System and VR Mesh (VirtualGrid, Bellevue City, WA) software. Also, we will compare the two different systems of 2D lingual orthodontic brackets  we will use in the retraction of the upper anterior teeth and to see if there is a relation between the type of tooth movement and the presence of root resorption. 
Also we plan to compare between VR Mesh and 3 Matic softwares regarding their accuracy to assess the volume of the tooth.

Trial website

Public notes

Contacts

Principal investigator

Name

A/Prof Tara Ali Rasheed

Address

University of Sulaimani/College of Dentistry Mitterrand Street. Sulaimani/Iraq P.O.Box 374

Country

Iraq

Phone

+9647701528496

Fax

tara.rasheed@univsul.edu.iq

Contact person for public queries

Name

Aram Ahmed Mohammed

Address

Iraq/ Sulaymaniyah Sulaymaniyah teaching hospital Mitterrand Street. Postcode 46001 P.O.Box Sulaymaniyah/Iraq 374

Country

Iraq

Phone

+9647701525394

Fax

kakarash1967@hotmail.com

Contact person for scientific queries

Name

Aras Maruf Rauf

Address

University of Sulaimani/College of Dentistry Mitterrand Street Postcode 46001

Country

Iraq

Phone

+9647702419930

Fax

aras.rauf@univsul.edu.iq

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:
• Available to who make research in this feild.

Conditions for requesting access:
• -

What individual participant data might be shared?

• The datas which evaluating the volume of root resorption through three dimension assessment.

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

• Available for the comparison purposes.

When can requests for individual participant data be made (start and end dates)?

From:
The datas will be available after two years from the date of publications.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• tara.rasheed@univsul.edu.iq

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5470	Statistical analysis plan			tara.rasheed@univsul.edu.iq		Study-related document.docx
6248	Informed consent form			tara.rasheed@univsul.edu.iq		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.

Trial Review

Documents added manually

Documents added automatically