Effectiveness of Modified Functional Appliance With Expander

Class II Malocclusion Clinical Trial

Official title:

A Modified Removable Orthodontic Appliance for Maxillary Expansion and Treatment of Class II Malocclusion: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06116500
• Other study ID #: 664422
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: June 9, 2024

Study information

• Verified date: October 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: June 9, 2024
• Est. primary completion date: May 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• Modified twin block appliance with expander
These appliances are myofunctional appliance used for treating class II division growing adolescents.
• Conventional twin block appliance with expander
These appliances are myofunctional appliances used for treating class II division growing adolescents.

Locations

Country	Name	City	State
Iraq	University of Baghdad, Collage of Dentistry	Baghdad	Al-Rusafa, Bab Al-moadham

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anteroposterior skeletal changes	Skeletal changes using cephalometric radiographs including different angular measurements to estimate the changes between dental bases before and after treatment.	T0 (before treatment), T1 (at end of the study) around 6-9 months
Primary	Vertical skeletal changes	Skeletal changes using cephalometric radiographs including different linear measurements to estimate the changes between dental bases before and after treatment.	T0 (before treatment), T1 (at end of the study) around 6-9 months.
Secondary	Soft tissue change	Measurements using cephalometric radiographs including different angular measurements to estimate the soft tissue changes before and after treatment.	T0 (before treatment), T1 (at end of the study) around 6-9 months
Secondary	Dentoalveolar changes	Measurements using cephalometric radiographs include different angular measurements to estimate the changes between teeth before and after treatment.	T0 (before treatment), T1 (at end of the study) around 6-9 months
Secondary	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.	T0 (before treatment), T1 (at end of the study) around 6-9 months.
Secondary	Patient satisfaction from the appliance	Patient satisfaction with both appliances will be estimated using a questionnaire at the middle of treatment.	around 4 months.