Protocol summary

Study aim
This study aimed to assess and compare the positional and dimensions changes in the Temporomandibular Joint disc resulting from various class II correctors before and after correcting the class II molar relation using MRI.
Design
Randomized, triple-blinded clinical trial of three groups of 13 patients in a single center
Settings and conduct
All patients, and who did data income analysis and statistician are unaware of grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria were set: 1. Clinical manifestation of a retrognathic mandible, as determined by cephalometric study, with an ANB angle larger than 4֯, due to the retrognathic mandible [SNB angle < 78◦] 2. Permanent dentition with angle Class II division 1 malocclusion with no missing or history of extraction. 3. Patients without history of TMJ dislocation or pain. 4. No history of orthodontic treatment. 5. Complete treatment records [cephalometric and panoramic X-ray, photography, and digital study models]. 6. Absence of transverse pre-treatment discrepancy. 7. Non-extraction treatment strategy and Class I occlusal relationship following treatment. 8. Cervical vertebrae maturation stages 4,5, and/or 6 in healthy pro-pubertal patients [17]. Patients having a history of trauma or TMJ operations, severe TMDs, systemic issues such as pregnancy, former orthodontic treatment, claustrophobia, or dental appliances or restorations that could have compromised patient safety during an MRI scan were not included in the study.
Intervention groups
the patients were allocated into three groups of 13 individuals each: Power scope 2[American Orthodontics], SARA-Sabagh Advanced Repositioning Appliance [Forestadent, Germany], CS-2000® Niti spring class II corrector [Dyna flex].
Main outcome variables
position and dimension of the articular disc, position of condyle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211003052655N1
Registration date: 2024-04-25, 1403/02/06
Registration timing: retrospective

Last update: 2024-04-25, 1403/02/06
Update count: 0
Registration date
2024-04-25, 1403/02/06
Registrant information
Name
Rebin Ali
Name of organization / entity
Hawler Medical University
Country
Iraq
Phone
+964 66 128 4932
Email address
rebin.amin@hmu.edu.krd
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-13, 1401/12/22
Expected recruitment end date
2024-01-15, 1402/10/25
Actual recruitment start date
2023-03-13, 1401/12/22
Actual recruitment end date
2024-01-15, 1402/10/25
Trial completion date
2024-01-15, 1402/10/25
Scientific title
Positional and Dimensional Tmj Changes Following the Use of Different Class II Correctors in a Sample of Erbil City [Randomized Clinical Trial]
Public title
Effect of different class II correctors on the TMJ
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical manifestation of a retrognathic mandible, as determined by cephalometric study, with an ANB angle larger than 4֯, due to the retrognathic mandible [SNB angle < 78◦] Permanent dentition with angle Class II division 1 malocclusion with no missing or history of extraction. Patients without history of TMJ dislocation or pain. No history of orthodontic treatment. Complete treatment records [cephalometric and panoramic X-ray, photography, and digital study models]. Absence of transverse pre-treatment discrepancy. Non-extraction treatment strategy and Class I occlusal relationship following treatment. Cervical vertebrae maturation stages 4,5, and/or 6 in healthy pro-pubertal patients
Exclusion criteria:
Patients having a history of trauma or TMJ operations, severe TMDs, systemic issues such as pregnancy, former orthodontic treatment, claustrophobia, or dental appliances or restorations that could have compromised patient safety during an MRI scan were not included in the study.
Age
From 15 years old to 23 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 39
More than 1 sample in each individual
Number of samples in each individual: 3
three groups of 13 individuals each: Power scope 2[American Orthodontics], SARA-Sabagh Advanced Repositioning Appliance [Forestadent, Germany], CS-2000® Niti spring class II corrector [Dyna flex].
Actual sample size reached: 13
Randomization (investigator's opinion)
Randomized
Randomization description
The study participants will be randomly assigned to different groups using an online randomization strategy developed by online software available on the website. https://www.graphpad.com/quickcalcs/. The allocation ratio will be determined as 1:1:1. The researchers involved in the study will be unaware of the group assignment. Following the initial clinical and radiological assessment, the patients will beallocated into three groups of 13 individuals each: Power scope 2[American Orthodontics], SARA-Sabagh Advanced Repositioning Appliance [Forestadent, Germany], CS-2000® Niti spring class II corrector [Dyna flex].
Blinding (investigator's opinion)
Triple blinded
Blinding description
Three groups of patients don't know which type of device will be used and the person who will do analysis of investigation and also who will do statistical analysis, are unaware of the randomization of groups.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Hawler medical university
Street address
Brayati
City
Erbil
Postal code
44001
Approval date
2023-01-16, 1401/10/26
Ethics committee reference number
HMU D.22

Health conditions studied

1

Description of health condition studied
Skeletal Class II malocclusion wirh retrognathic mandible
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device

Primary outcomes

1

Description
Disc size and width, position and dimensional change of disc, position of condyle
Timepoint
before placement and one day after correction of the class II molar relationship
Method of measurement
Magnetic resonance Imaging

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Powerscope 2 (American Orthodontics) class II corrector
Category
Treatment - Devices

2

Description
Intervention group: CS-2000 (Dyna flex) class II corrector
Category
Treatment - Devices

3

Description
Intervention group: SARA (Sabbagh Advanced Repositioning Appliance) Forestadent Class II corrector
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthodontic Department, College of Dentistry, Hawler Medical University
Full name of responsible person
Rebin Ali MohammedAmeen
Street address
Brayati
City
Erbil
Postal code
44001
Phone
+964 750 446 5638
Email
rebin.amin@hmu.edu.krd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hawler Medical University
Full name of responsible person
Ethic committee of Hawler medical university
Street address
Brayati
City
Erbil
Postal code
44001
Phone
+964 750 475 8098
Email
asmaaqasm@hmu.edu.krd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hawler Medical University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
hawler Medical University
Full name of responsible person
Rebin Ali Mohammedameen
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Brayati
City
Erbil
Province
Erbil
Postal code
44001
Phone
+964 750 128 4932
Email
rebin.amin@hmu.edu.krd

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hawler Medical University
Full name of responsible person
Rebin Ali Mohammedameen
Position
Lecturer/ Hawler Medical University
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Brayati
City
Erbil
Province
Erbil
Postal code
44001
Phone
+964 750 128 4932
Email
rebin.amin@hmu.edu.krd

Person responsible for updating data

Contact
Name of organization / entity
Hawler Medical University
Full name of responsible person
Ethic committee of Hawler medical university
Position
Lecturer, PhD student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Brayati
City
Erbil
Province
Erbil
Postal code
44001
Phone
+964 66 128 4932
Fax
Email
rebin.amin@hmu.edu.krd

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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