NCT07454694

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

August 25, 2025

Last Update Submit

March 2, 2026

Conditions

Class II MalocclusionMandibular Retrognathism

Keywords

Class II malocclusionTwinblockclear alignersmandibular advancement

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Cephalometric Measurements (mm and degrees) After Functional Appliance Therapy

    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.

    Baseline and after completion of functional appliance therapy (approximately 7-13 months)

  • Change from Baseline in Mandibular Bone Fractal Dimension Values After Functional Appliance Therapy

    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.

    Baseline and after completion of functional appliance therapy (approximately 7-13 months)

Study Arms (2)

Clear Aligner Group

EXPERIMENTAL

Mandibular advancement with clear aligners

Device: Invisalign Clear Aligners

Twinblock Group

EXPERIMENTAL

Mandibular Advancement with Twinblock Functional Appliance

Device: Twinblock Functional Appliance

Interventions

Invisalign Clear AlignersDEVICE

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.

Clear Aligner Group
Twinblock Functional ApplianceDEVICE

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.

Twinblock Group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Ezgi Sunal Akturk, Assistant Professor

    Saglik Bilimleri Universitesi

    STUDY CHAIR

  • Gokmen Kurt, Professor

    Bezmialem Vakif University

    STUDY CHAIR

  • Ahsen Irem Toktas, Research Assistant

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

March 6, 2026

Study Start

August 1, 2023

Primary Completion

July 22, 2025

Study Completion

August 1, 2025

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

TU(1)