Comparison Of The Effects Of Clear Aligners And Twinblock Appliances In Functional Treatment Of Class II Malocclusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bezmialem Vakif University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Cephalometric Measurements (mm and degrees) After Functional Appliance Therapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 14 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Clear Aligner Group
Mandibular advancement with clear aligners
Intervention: Invisalign Clear Aligners (Device)
Twinblock Group
Mandibular Advancement with Twinblock Functional Appliance
Intervention: Twinblock Functional Appliance (Device)
Outcomes
Primary Outcomes
Change from Baseline in Cephalometric Measurements (mm and degrees) After Functional Appliance Therapy
Time Frame: Baseline 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 Therapy
Time Frame: Baseline 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.
Secondary Outcomes
No secondary outcomes reported