Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance

NCT ID: NCT06589206

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-30

Brief Summary

The aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed.

Detailed Description

Twin block appliance is the gold standard for the treatment of skeletal class II patients with deficient mandible. Yet, it has some drawbacks as proclination of the mandibular incisors, development of posterior open bite and the unesthetic appearance. Many modifications in twin block A new design were made to overcome the previous problems, as adding incisor capping, Clasps, sagittal blocks, and esthetic twin block appliances. In the current trial A new design of esthetic twin block appliance with sagittal blocks is investigated and the post treatment skeletal, dental, and soft tissue, TMJ, and upper airway size will be assessed and compared to the changes associated with the conventional design of twin block. Moreover, patient satisfaction with the appliance will be assessed with both appliances.

Conditions

Growth Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional twin block

Growing patients with class II skeletal discrepancy due to mandibular deficiency will be treated with the conventional design of twin block previously introduced by Clark.

Group Type: ACTIVE_COMPARATOR

modified design of twin block

Intervention Type: OTHER

Vacuum formed twin block appliance with sagittal blocks

Vacuum formed twin block appliance with sagittal blocks

Growing patients with class II skeletal discrepancy due to mandibular deficiency will be treated with a modified design of twin block formed of vacuum sheets with sagittal blocks.

Group Type: EXPERIMENTAL

modified design of twin block

Intervention Type: OTHER

Vacuum formed twin block appliance with sagittal blocks

Interventions

modified design of twin block

Vacuum formed twin block appliance with sagittal blocks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• skeletal class II deficient mandible
• Class II molar and canine relation
• male growing patients CVM 2,3 age range 10-14
• normal vertical growth pattern
• ANB > 4
• mild to moderate crowding

Exclusion Criteria

• Previous orthodontic treatment.
• Craniofacial syndrome.
• Periodontal disease.
• Extracted first permanent molars.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aml Saeed Mohamed Abdel qader

Lecturer Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3444

Identifier Type: -

Identifier Source: org_study_id