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Fixed Versus Conventional Twin Block Appliances for Skeletal Class II Malocclusion

Dentoskeletal and Condylar Evaluation of Skeletal Class II Malocclusion by Fixed Twinblock Appliance Versus Conventional Twin Block Appliance Cone Beam Computed Tomography Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07687927
Enrollment
20
Registered
2026-07-07
Start date
2023-11-08
Completion date
2025-12-24
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Retrognathia, Skeletal Class II Malocclusion

Keywords

Twin Block Appliance, Mandibular Advancement, Functional Appliance, Cone Beam Computed Tomography, Temporomandibular Joint, Growing Patients, Class II Malocclusion

Brief summary

This study compares two types of dental appliances a fixed Twin Block appliance and a conventional (removable) Twin Block appliance used to treat a bite problem called skeletal Class II malocclusion in growing children and teenagers. In this condition, the lower jaw is positioned further back than the upper jaw. Both appliance types work by guiding the lower jaw forward during growth. The study uses 3D imaging (cone beam computed tomography, or CBCT) before and after treatment to measure how each appliance affects the bones of the jaw, the teeth, the soft tissue profile of the face, and the jaw joint (temporomandibular joint). The goal is to determine whether the fixed or the conventional version of the appliance produces better treatment outcomes.

Detailed description

This comparative clinical study evaluates the skeletal, dentoalveolar, soft-tissue, and condylar/temporomandibular joint (TMJ) effects of fixed versus conventional Twin Block appliances in growing patients diagnosed with skeletal Class II malocclusion due to mandibular retrognathia. Participants were allocated to receive treatment with either a fixed or a conventional (removable) Twin Block appliance. Pre-treatment and post-treatment cone beam computed tomography (CBCT) scans were obtained to assess sagittal jaw relationships, mandibular advancement, dentoalveolar changes (including overjet and overbite correction), soft-tissue profile changes, and condylar position/remodeling within the glenoid fossa, including TMJ disc space measurements. Outcomes between the two appliance groups were compared to evaluate differences in skeletal and dental effects, as well as any differences in condylar/TMJ adaptation associated with each appliance design.

Interventions

DEVICEConventional Twin Block Appliance

A removable functional appliance consisting of upper and lower acrylic occlusal bite blocks used to advance the mandible and correct skeletal class II malocclusion in growing patients

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Two parallel groups: fixed Twin Block appliance versus conventional Twin Block appliance.

Eligibility

Sex/Gender
MALE
Age
11 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

1. Growing male patients (as judged from clinical examination and confirmed later by (CVM) 2. Skeletal class II with retrognathic mandible. 3. Healthy compliant and motivated patient. 4. No Previous orthodontic treatment. 5. No Severe facial asymmetry determined by clinical or radiographic examination. 6. No Systemic diseases that may affect the treatment results. 7. No tmj disorders.

Exclusion criteria

1. Previous orthodontic treatment. 2. Poor oral hygiene. 3. Severe facial asymmetry determined by clinical or radiographic examination. 4. Systemic disease that may affect the treatment results. 5. TMJ disorders.

Design outcomes

Primary

MeasureTime frameDescription
Change in Sagittal Skeletal Relationship (ANB Angle)Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)Measured using cone beam computed tomography (CBCT), the ANB angle reflects the anteroposterior relationship between the maxilla and mandible. Pre-treatment and post-treatment values will be compared between the fixed and conventional Twin Block appliance groups to assess skeletal correction of Class II malocclusion.

Secondary

MeasureTime frameDescription
Change in Sagittal Skeletal Relationship (ANB Angle)Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)Measured using cone beam computed tomography (CBCT), the ANB angle reflects the anteroposterior relationship between the maxilla and mandible. Pre-treatment and post-treatment values will be compared between the fixed and conventional Twin Block appliance groups to assess skeletal correction of Class II malocclusion.
Change in Condylar Position and TMJ Disc SpaceMeasured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)Measured using cone beam computed tomography (CBCT), condylar position within the glenoid fossa will be assessed by evaluating anterior, superior, and posterior joint spaces. TMJ disc space measurements will also be recorded to evaluate condylar remodeling and adaptation. Pre-treatment and post-treatment values will be compared between the fixed and conventional Twin Block appliance groups.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026