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Search / Trial NCT05950581

Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates

Launched by HAMA UNIVERSITY · Jul 10, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for children and adolescents with a specific type of dental misalignment called Skeletal Class II malocclusion, where the lower jaw is positioned further back than the upper jaw. The trial will compare the effects of a modified twin-block appliance that uses clear plates to traditional fixed braces. Researchers want to see how well this new device works in changing the shape of the jaw and teeth, as well as any effects on the surrounding soft tissues.

To participate in this study, children aged 10.5 to 13 years who have not had any previous orthodontic treatment and meet specific dental criteria related to their jaw alignment may be eligible. Participants must be willing to wear a removable appliance and must not have any other major dental or health issues. Throughout the study, participants will receive the new treatment and will be monitored to assess how their dental and facial structure changes over time. This trial is currently recruiting participants, and it aims to provide valuable insights into new approaches for correcting jaw alignment issues in young patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • - Patients with mixed dentition at age 10.5-13 years.
  • The patient has Skeletal class II malocclusion caused by mandibular retraction ANB \> 5, 8 mm \>O.J\> 5 mm, SNB\<78, angle (NSAr) ≥ ° 125 and normal placement of the upper jaw.
  • The patient is willing to accept treatment with a removable device.
  • No previous orthodontic treatment
  • the growth model is within the normal or horizontal maxillary opening angle of 30 \>MM or angle of 400 \> Björk
  • patients do not have an upper alveolar dental protrusion.
  • Exclusion Criteria:
  • -Patients with periodontal disease.
  • patients with a neuromuscular disorder.
  • patients of class I or III of malocclusion.
  • Patients with temporomandibular joint disorder.
  • Patients with Skeletal open bite.
  • Patients with poor oral and gingival health
  • the presence of a unilateral or bilateral posterior crossbite.
  • patients who have upper jaw stenosis and need to be prepared by expansion before functional treatment.
  • any patient who does not meet one or more of the Inclusion criteria will be removed from the study.

About Hama University

Hama University is a leading academic institution dedicated to advancing medical research and clinical trials aimed at improving healthcare outcomes. With a commitment to innovation and excellence, the university collaborates with multidisciplinary teams of researchers, clinicians, and industry partners to develop and evaluate novel therapies and treatment protocols. Hama University’s clinical trial efforts are characterized by rigorous scientific methodology, ethical standards, and a focus on patient-centered outcomes, positioning it as a pivotal contributor to the advancement of medical knowledge and the enhancement of community health.

Locations

Hama, , Syrian Arab Republic

Patients applied

0 patients applied

Trial Officials

Rabab Alsabbagh,, DDS MSc PhD

Study Director

Professor of Orthodontics, University of Hama Dental School, Hama, Syria.

ANAS FAKHOURI

Principal Investigator

Student in Orthodontics, University of Hama Dental School, Hama.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported