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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).
It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: Myobrace appliance will be used while, and group two Twin-block appliances will be used. Cephalometric x-ray will be taken before starting the treatment (T1) and at the end of treatment (T2) at 9 months. The effectiveness of the two appliances will be assessed and measured comparing the difference in the cephalometric X-ray before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myobrace group | Experimental | Myobrace appliance will be used for children who have Cl.II div.a malocclusion |
|
| Twin-block group | Experimental | Twin-block appliance will be used for children who have Cl.II div.a malocclusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofunctional appliance | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue changes | 2. Soft tissue changes using cephalometric radiographs including different angular measurement such as E-line and nasolabial angle (comparing the changes in the photographs at the beginning of the treatment and at the end of the treatment. | T1 at the start of treatment and T2 at the end of treatment around 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mushriq Abid | Contact | 7718800706 | 00964 | mushriq.abid@codental.uobaghdad.edu.iq |
| Mushriq Abid | Contact | mushriqfawzi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry-University of Baghdad | Recruiting | Baghdad | Al-Rusafa | 01110 | Iraq |
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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.
| Patient satisfaction |
3.Patient satisfaction with both appliances will be investigated using a questionnaire at the end of the study (around 9 months) |
| At the end of treatment (around 9 months) |
| College of Dentisry-University of Baghdad | Recruiting | Baghdad | Iraq |
|