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Comparison Of The Effects Of Clear Aligners And Twinblock Appliances In Functional Treatment Of Class II Malocclusion

Comparison Of The Effects Of Clear Aligners And Twinblock Appliances In Functional Treatment Of Class II Malocclusion

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07454694
Enrollment
34
Registered
2026-03-06
Start date
2023-08-01
Completion date
2025-08-01
Last updated
2026-03-06

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

Conditions

Class II Malocclusion, Mandibular Retrognathism

Keywords

Class II malocclusion, Twinblock, clear aligners, mandibular advancement

Brief summary

This prospective clinical study aimed to compare the skeletal and dentofacial effects of Twin Block (TWB) and clear aligners with mandibular advancement, and to evaluate mandibular trabecular bone changes through fractal analysis (FA).

Detailed description

A total of 34 patients with dentoskeletal Class II malocclusion were included in the study: 16 patients in the Invisalign® Mandibular Advancement (MA) group and 18 patients in the TWB group .Panoramic and lateral cephalometric radiographs were obtained at baseline(T0) and after functional treatment(T1). Skeletal, dental, and soft tissue structures were evaluated on the pretreatment and posttreatment radiographs using cephalometric analysis, while trabecular bone architecture was assessed by fractal analysis.

Interventions

DEVICEInvisalign Clear Aligners

Functional appliances are used for mandibular advancement in the treatment of mandibular retrognathia in orthodontics. The Twinblock is a conventional functional appliance, and nowadays mandibular advancement can also be achieved with clear aligners. In this study, these two appliances were used.

DEVICETwinblock Functional Appliance

Functional appliances are used for mandibular advancement in the treatment of mandibular retrognathia in orthodontics. The Twinblock is a conventional functional appliance, and nowadays mandibular advancement can also be achieved with clear aligners. In this study, these two appliances were used.

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* Patients with Angle Class II molar and canine relationship * Overjet greater than 6 mm * Patients in the growth spurt period

Exclusion criteria

* History of orthodontic treatment * Missing teeth * Patients in mixed dentition period * Systemic diseases affecting growth or bone metabolism

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Cephalometric Measurements (mm and degrees) After Functional Appliance TherapyBaseline and after completion of functional appliance therapy (approximately 7-13 months)Cephalometric measurements will be evaluated on lateral cephalometric radiographs using a customized analysis derived from Steiner, McNamara, Tweed, Ricketts, and Arnett analyses. A total of 47 skeletal, dental, airway, hyoid, and soft tissue parameters will be assessed. Linear measurements will be recorded in millimeters (mm) and angular measurements in degrees. Landmarks will be manually identified on digital lateral cephalometric radiographs.
Change from Baseline in Mandibular Bone Fractal Dimension Values After Functional Appliance TherapyBaseline and after completion of functional appliance therapy (approximately 7-13 months)Fractal dimension values will be calculated using the box-counting method on panoramic radiographs (mandibular condyle, angulus, and corpus) and lateral cephalometric radiographs (symphysis). Fractal dimension is a unitless numerical value used to evaluate trabecular bone complexity. Higher values indicate greater trabecular complexity, whereas lower values indicate reduced trabecular structure.

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIREzgi Sunal Akturk, Assistant Professor

Saglik Bilimleri Universitesi

STUDY_CHAIRGokmen Kurt, Professor

Bezmialem Vakif University

PRINCIPAL_INVESTIGATORAhsen Irem Toktas, Research Assistant

Bezmialem Vakif University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026