Treatment for jaw misalignment using a new appliance

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

This study is testing a new jaw appliance to see if it works better than a traditional one for people with a misaligned jaw.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 10 Years to 13 Years
• Sex: All
• Sponsor: Hama University (other)
• Locations: 1 site (Hama)
• Trial ID: NCT05950581 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a Modified Twin-Block Appliance with Clear Plates in treating patients with skeletal Class II malocclusion, characterized by a retracted lower jaw. Participants will be divided into two groups: one receiving the new appliance and the other receiving the traditional Twin-Block Appliance. The study aims to assess changes in skeletal, dental, and soft tissue structures resulting from these interventions. The outcomes will be compared to determine the efficacy of the new treatment approach.

Who should consider this trial

Good fit: Ideal candidates are children aged 10.5 to 13 years with specific skeletal Class II malocclusion characteristics and no prior orthodontic treatment.

Not a fit: Patients with periodontal disease, neuromuscular disorders, or other types of malocclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and comfortable option for correcting jaw misalignment in young patients.

How similar studies have performed: While traditional approaches have been established, the use of clear plates in this context is a novel approach that has not been extensively tested.

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.

Where this trial is running

Hama

• Hama University — Hama, Syria (RECRUITING)

Study contacts

• Principal investigator: ANAS FAKHOURI — Student in Orthodontics, University of Hama Dental School, Hama.
• Study coordinator: Fadi Jnaid

Conditions: Malocclusion, Angle Class II