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Modified Versus Clear Twin Block for Skeletal Class II Malocclusion

NCT07608406 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-27

No results posted yet for this study

Summary

This study aims to evaluate the effectiveness of a modified Twin Block appliance compared to a conventional clear Twin Block appliance in the treatment of skeletal Class II malocclusion caused by mandibular retrusion in growing patients.

This is a two-arm randomized controlled clinical trial including patients aged 10-13 years diagnosed with skeletal Class II malocclusion. Participants will be randomly allocated into two equal groups.

Skeletal, dental, and soft tissue changes will be assessed using lateral cephalometric analysis and cone-beam computed tomography (CBCT). Additionally, temporomandibular joint (TMJ) health, pain perception, and functional tolerance will be evaluated using standardized clinical indices and patient-reported outcome measures.

The study aims to compare the modified appliance with the conventional design in terms of skeletal improvement, TMJ safety, and patient acceptance.

Conditions

  • Skeletal Class II Malocclusion

Interventions

DEVICE

Modified Twin Block Appliance

A modified Twin Block functional appliance incorporating progressive mandibular advancement and lower lip pads designed to modify muscular activity and enhance mandibular growth. The appliance is used for the treatment of skeletal Class II malocclusion due to mandibular retrusion in growing patients.

DEVICE

Conventional Clear Twin Block Appliance

A conventional clear Twin Block functional appliance used for correction of skeletal Class II malocclusion in growing patients. The appliance acts by posturing the mandible forward to stimulate functional and skeletal adaptation.

Sponsors & Collaborators

  • University of Aleppo

    lead OTHER

Principal Investigators

  • Abdulmalek Majanni, PhD · Faculty of Dentistry, University of Aleppo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608406 on ClinicalTrials.gov