Tooth Position Anomalies
Conditions
Keywords
Myofunctional appliance, Myobrace., Twin-block, Cl II div I malocclusion
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).
Detailed description
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.
Interventions
DEVICEMyofunctional appliance
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
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
1. Growing children who need myofunctional appliance. 2. Cl II div. 1 malocclusion. 3. No previous orthodontic or orthopaedic treatments.
Exclusion criteria
1. Patients with systemic involvement. 2. Congenital malformations such as cleft lip and palate. 3. Facial deformities. 4. Finger sucking habit will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dentoskeletal changes | T1 at the start of treatment and T2 at the end of treatment around 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue changes | T1 at the start of treatment and T2 at the end of treatment around 9 months | 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. |
| Patient satisfaction | At the end of treatment (around 9 months) | 3.Patient satisfaction with both appliances will be investigated using a questionnaire at the end of the study (around 9 months) |
Countries
Iraq
Contacts
Primary ContactMushriq Abid
Backup ContactMushriq Abid
Outcome results
None listed