This clinical trial compares the effectiveness of a myofunctional appliance that uses a clear and modified twin block appliance with an expander made from 2mm biocompatible polyethylene terephthalate modified with Glycol thermoplastic material with a conventional twin block appliance with an expander. The trial will be conducted on adolescent patients with class II division 1.
In a multicenter single-blinded randomized clinical trial study with two-arm parallel groups, a computer random generator will develop a simple randomization with an equal allocation ratio (1:1) and without stratification. The investigator will initially assess the patients for eligibility to be included in the study. Those who will meet the inclusion criteria, the parents will be informed about the nature of the study verbally to get the initial approval for participation. Then they will be provided with the patient information sheet and consent form. According to the sample size calculation, 48 patients will be recruited (24 for each group), and impressions and lateral cephalometric radiography will be taken before treatment and bite registration then the appliance inserted, and the patient will be checked every two weeks for expansion and every four weeks for overjet recording. The treatment will be continuing for 6 months to take final records. The collected data will include cephalometric evaluation, clinical evaluation, scanned upper model evaluation, and finally patient satisfaction from the appliance. Data will be analyzed using Statistical Package for Social Sciences for Windows, version 26.0 including descriptive statistic (number, mean, and standard deviation), Reliability statistic (interclass correlation coefficient), and Inferential statistics (independent samples t-test).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
These appliances are myofunctional appliance used for treating class II division growing adolescents.
These appliances are myofunctional appliances used for treating class II division growing adolescents.
University of Baghdad, Collage of Dentistry
Baghdad, Al-Rusafa, Bab Al-moadham, Iraq
Anteroposterior skeletal changes
Skeletal changes using cephalometric radiographs including different angular measurements to estimate the changes between dental bases before and after treatment.
Time frame: T0 (before treatment), T1 (at end of the study) around 6-9 months
Vertical skeletal changes
Skeletal changes using cephalometric radiographs including different linear measurements to estimate the changes between dental bases before and after treatment.
Time frame: T0 (before treatment), T1 (at end of the study) around 6-9 months.
Soft tissue change
Measurements using cephalometric radiographs including different angular measurements to estimate the soft tissue changes before and after treatment.
Time frame: T0 (before treatment), T1 (at end of the study) around 6-9 months
Dentoalveolar changes
Measurements using cephalometric radiographs include different angular measurements to estimate the changes between teeth before and after treatment.
Time frame: T0 (before treatment), T1 (at end of the study) around 6-9 months
Study model evaluation
The scanned upper study model will be used to calculate the amount of expansion before and at the end of the study.
Time frame: T0 (before treatment), T1 (at end of the study) around 6-9 months.
Patient satisfaction from the appliance
Patient satisfaction with both appliances will be estimated using a questionnaire at the middle of treatment.
Time frame: around 4 months.
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