NCT06935032

Brief Summary

This study aimed to evaluate the changes in mandibular and cervical soft tissues in Class II patients with mandibular retrognathia treated with the Twin Block appliance, compared to skeletal Class I patients without functional treatment, using profile photographs and cephalometric films. Sixteen patients with Class II Division 1, fifteen with Class II Division 2, and fifteen with skeletal Class I malocclusion were included. Measurements were performed at the beginning of treatment and after functional therapy. In the Class II Div 1 group, most parameters showed significant reductions, except for neck length and jaw tip contour. In the Class II Div 2 group, only the Sm-E plane measurement remained unchanged, while the control group showed minimal changes. Between-group comparisons indicated significant improvements in cervicomental angle, lip-jaw-throat angle, and other lower face soft tissue parameters, especially in Class II Division 1 patients. The findings suggest that Twin Block therapy effectively improves both skeletal and soft tissue profiles, with more pronounced soft tissue enhancement in Class II Division 1 cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

April 4, 2025

Last Update Submit

April 11, 2025

Conditions

Mandibular Retrognathism

Keywords

: Functional appliancessoft tissue change

Outcome Measures

Primary Outcomes (1)

  • Patients treated with the Twin Block appliance

    The changes in certain angular (degrees) and linear (millimeters) measurements may be considered favorable for the mandibular soft tissues.

    12 month

Study Arms (3)

Class II Division I malocclusion caused by mandibular retrognathia

EXPERIMENTAL

Class II Division I patients treated with the Twin Block appliance

Device: Twin block appliance

Class II Division II malocclusion caused by mandibular retrognathia

EXPERIMENTAL

Class II Division II patients treated with the Twin Block appliance

Device: Twin block appliance

Skeletal Class I patients

EXPERIMENTAL

Class I patients who received fixed treatment

Other: Fixed orthodontic treatment

Interventions

Twin block applianceDEVICE

An appliance that facilitates forward positioning of the mandible and soft tissues

Class II Division I malocclusion caused by mandibular retrognathiaClass II Division II malocclusion caused by mandibular retrognathia
Fixed orthodontic treatmentOTHER

Patients undergoing orthodontic treatment with fixed appliances

Skeletal Class I patients

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • having Class II malocclusion caused by mandibular retrognathia (ANB \> 4°, SNB\<78°),
  • exhibiting horizontal and/or normal growth pattern (SN-GoGn=32 ±6),
  • having profile photographs and cephalometric radiographs taken in the NHP (using the self-balance method one of the dynamic approaches for determining NHP)15,
  • not requiring rapid maxillary expansion,
  • not having increased initial lower incisor inclination on lateral cephalometric radiographs,
  • Class II Division 2 patients presenting with ≥4 mm deepbite and the absence of any prior upper incisor protrusion methods,
  • the control group individuals were required to have a skeletal Class I pattern (ANB angle between 0-4°) without any dental deficiencies.

You may not qualify if:

  • previous orthodontic treatment,
  • presence of craniofacial anomalies involving the jaw and/or teeth,
  • severe facial asymmetry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (1)

  • Malkoc S, Demir A, Uysal T, Canbuldu N. Angular photogrammetric analysis of the soft tissue facial profile of Turkish adults. Eur J Orthod. 2009 Apr;31(2):174-9. doi: 10.1093/ejo/cjn082. Epub 2008 Dec 8.

    PMID: 19064675RESULT

Study Officials

  • Seda Sağoğlu

    Konya Necmettin Erbaka University Faculty of Dentistry

    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
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant / Principal Investigator

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 18, 2025

Study Start

November 25, 2021

Primary Completion

June 28, 2023

Study Completion

July 24, 2023

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)