A Comparison of the Effectiveness of Two Types of Myofunctional Appliances
1 other identifier
interventional
30
1 country
2
Brief Summary
A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2021
CompletedFirst Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2024
CompletedNovember 28, 2023
November 1, 2023
2.8 years
April 26, 2022
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dentoskeletal changes
Evaluation of dentoskeletal and soft tissue changes following the treatment of growing children with myobrace and twin block appliances. Using cephalometric analysis to measure the angles including dental angles such as inter-incisal angle, in addition to skeletal angles such as SNA,SNB and ANB angles.
T1 at the start of treatment and T2 at the end of treatment around 9 months
Secondary Outcomes (2)
Soft tissue changes
T1 at the start of treatment and T2 at the end of treatment around 9 months
Patient satisfaction
At the end of treatment (around 9 months)
Study Arms (2)
Myobrace group
EXPERIMENTALMyobrace appliance will be used for children who have Cl.II div.a malocclusion
Twin-block group
EXPERIMENTALTwin-block appliance will be used for children who have Cl.II div.a malocclusion
Interventions
Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance
Eligibility Criteria
You may qualify if:
- Growing children who need myofunctional appliance.
- Cl II div. 1 malocclusion.
- No previous orthodontic or orthopaedic treatments.
You may not qualify if:
- Patients with systemic involvement.
- Congenital malformations such as cleft lip and palate.
- Facial deformities.
- Finger sucking habit will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
College of Dentistry-University of Baghdad
Baghdad, Al-Rusafa, 01110, Iraq
College of Dentisry-University of Baghdad
Baghdad, Iraq
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinding to treatment allocation is possible only for the outcomes assessor because the clinicians could know the intervention. All the trial documents will be labeled with the study ID number, which be used for participant identification and data collection without unmasking the allocation group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 26, 2022
First Posted
May 12, 2022
Study Start
September 10, 2021
Primary Completion
July 10, 2024
Study Completion
August 10, 2024
Last Updated
November 28, 2023
Record last verified: 2023-11