Effectiveness of Modified Functional Appliance With Expander

Sponsor

University of Baghdad (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06116500

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Class II Malocclusion	Device: Modified twin block appliance with expander Device: Conventional twin block appliance with expander	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The patients will be treated with twin block applianceThe patients will be treated with twin block appliance

Masking:

Single (Participant)

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 9, 2023

Anticipated Primary Completion Date :

May 9, 2024

Anticipated Study Completion Date :

Jun 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Modified twin block appliance with expander group For 24 patients with class II division malocclusion in their growing stages, using a 2 mm biocompatible and rigid PET-G thermoforming material to create two clear appliances for each patient. The material will be adapted separately on maxillary and mandibular casts using a pressure molding vacuum machine. Then, the appliances will be trimmed and finished and transferred to the articulator with the aid of a pre-existing working wax bite. The ramps will be made of cold cure acrylic on the thermoplastic sheets. Next, the expansion screw will be placed in the midline of the maxillary cast, and the maxillary appliance will be split midpalatally to fit the patient's individual needs.	Device: Modified twin block appliance with expander These appliances are myofunctional appliance used for treating class II division growing adolescents. Device: Conventional twin block appliance with expander These appliances are myofunctional appliances used for treating class II division growing adolescents.
Experimental: Conventional twin block appliance with expander group For 24 patients in a growing stage with class II division 1 malocclusion, these appliances will consist of removable maxillary and mandibular appliances. These will have a labial bow, Adam's clasps on the first molars, ball end clasps with incisal capping and expansion screw. The inclined bite blocks (ramps) will act as a guide to move the mandible forward.	Device: Modified twin block appliance with expander These appliances are myofunctional appliance used for treating class II division growing adolescents. Device: Conventional twin block appliance with expander These appliances are myofunctional appliances used for treating class II division growing adolescents.

Arm

Intervention/Treatment

Experimental: Modified twin block appliance with expander group

For 24 patients with class II division malocclusion in their growing stages, using a 2 mm biocompatible and rigid PET-G thermoforming material to create two clear appliances for each patient. The material will be adapted separately on maxillary and mandibular casts using a pressure molding vacuum machine. Then, the appliances will be trimmed and finished and transferred to the articulator with the aid of a pre-existing working wax bite. The ramps will be made of cold cure acrylic on the thermoplastic sheets. Next, the expansion screw will be placed in the midline of the maxillary cast, and the maxillary appliance will be split midpalatally to fit the patient's individual needs.

Device: Modified twin block appliance with expander

These appliances are myofunctional appliance used for treating class II division growing adolescents.

Device: Conventional twin block appliance with expander

These appliances are myofunctional appliances used for treating class II division growing adolescents.

Experimental: Conventional twin block appliance with expander group

For 24 patients in a growing stage with class II division 1 malocclusion, these appliances will consist of removable maxillary and mandibular appliances. These will have a labial bow, Adam's clasps on the first molars, ball end clasps with incisal capping and expansion screw. The inclined bite blocks (ramps) will act as a guide to move the mandible forward.

Device: Modified twin block appliance with expander

These appliances are myofunctional appliance used for treating class II division growing adolescents.

Device: Conventional twin block appliance with expander

These appliances are myofunctional appliances used for treating class II division growing adolescents.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients' age at the start of treatment: at growth spurt [in stage 2 (Acceleration) - 3 (Transition) of cervical vertebral maturation].
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.
Horizontal/normal growth pattern.
Convex profile with decreased or normal lower facial height (clinically and radiographically).
Well-aligned/mild crowding of maxillary and mandibular dental arches.
Good oral health free from caries and periodontal problems at the start of treatment.