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

Not Applicable

Not yet recruiting

• Conditions: Growth Modification
• Interventions: Other: modified design of twin block

• Registration Number: NCT06589206
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2024-08-24
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-10
• Last Update Submitted: 2024-09-15
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional twin block	modified design of 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.
Vacuum formed twin block appliance with sagittal blocks	modified design of twin block	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.

Primary Outcome Measures

Name	Time	Method
skeletal changes	9 months	changes in SNA, SNB, and ANB angles will be measured before and after treatment
Dental changes	9 months	changes in maxillary and mandibular incisors position and inclination will be assessed before and after treatment

Secondary Outcome Measures

Name	Time	Method
soft tissue changes	9 months	changes in soft tissue A, B, Pog points will be assessed before and after treatment
JMJ changes	9 months	changes in the TMJ morphologic structure will be assessed before and after treatment
Upper airway size	9 months	changes in the Upper airway size will be assessed before and after treatment
patient satisfaction	after one and nine months	patients acceptance of the appliance will be assessed by a questionnaire administered in one to one interview.