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

Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance for Treatment of Skeletal Class II Growing Patients With Mandibular Deficiency: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Growth Modification
• Intervention / Treatment: Other: modified design of twin block

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: modified design of twin block; Vacuum formed twin block appliance with sagittal blocks
Experimental: 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.	Other: modified design of twin block; Vacuum formed twin block appliance with sagittal blocks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: August 24, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Estimated): September 10, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 15, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: twin block; esthetic twin block; clear twin block; Deficient mandible; Skeletal Class II
• Other Study ID Numbers: 3444

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No