Class II Malocclusion
Conditions
Keywords
twin block, thermoplastic material, clear expander,, adolescent, clinical trial
Brief summary
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.
Detailed description
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).
Interventions
DEVICEModified twin block appliance with expander
These appliances are myofunctional appliance used for treating class II division growing adolescents.
DEVICEConventional twin block appliance with expander
These appliances are myofunctional appliances used for treating class II division growing adolescents.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
In the study, data collection and measurement will be conducted with the investigator. However, it won't be possible to blind the operator (investigator) due to the appliance design/shape difference, making the study single-blinded. Each patient will not know which type of twin block appliance will be used for them.
Intervention model description
The patients will be treated with twin block appliance
Eligibility
Sex/Gender
ALL
Age
10 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients' age at the start of treatment: at growth spurt \[in stage 2 (Acceleration) - 3 (Transition) of cervical vertebral maturation\]. 2. Skeletal and dental relationships: skeletal class II with normal maxilla and retrognathic mandible. Moderate to severe dental class II division 1 malocclusion with overjet ≥ 8 mm. 3. Horizontal/normal growth pattern. 4. Convex profile with decreased or normal lower facial height (clinically and radiographically). 5. Well-aligned/mild crowding of maxillary and mandibular dental arches. 6. Good oral health free from caries and periodontal problems at the start of treatment.
Exclusion criteria
1. Patients with vertical growth pattern or backward mandibular rotation tendency. 2. Patients with open bite 3. Patients with obvious facial asymmetry. 4. Patients with orofacial clefting. 5. Patients with bad oral habits. 6. Active periodontal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anteroposterior skeletal changes | T0 (before treatment), T1 (at end of the study) around 6-9 months | Skeletal changes using cephalometric radiographs including different angular measurements to estimate the changes between dental bases before and after treatment. |
| Vertical skeletal changes | T0 (before treatment), T1 (at end of the study) around 6-9 months. | Skeletal changes using cephalometric radiographs including different linear measurements to estimate the changes between dental bases before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue change | T0 (before treatment), T1 (at end of the study) around 6-9 months | Measurements using cephalometric radiographs including different angular measurements to estimate the soft tissue changes before and after treatment. |
| Dentoalveolar changes | T0 (before treatment), T1 (at end of the study) around 6-9 months | Measurements using cephalometric radiographs include different angular measurements to estimate the changes between teeth before and after treatment. |
| Study model evaluation | T0 (before treatment), T1 (at end of the study) around 6-9 months. | The scanned upper study model will be used to calculate the amount of expansion before and at the end of the study. |
| Patient satisfaction from the appliance | around 4 months. | Patient satisfaction with both appliances will be estimated using a questionnaire at the middle of treatment. |
Countries
Iraq
Outcome results
None listed