Completed

Mandibular Soft Tissue Changes in Class II Malocclusion with Twin Block Appliance

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What is being tested

Twin block appliance

+ Fixed orthodontic treatment

DeviceOther
Who is being recruted

From 11 to 14 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2021
See protocol details

Summary

Principal SponsorKonya Necmettin Erbakan Üniversitesi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 25, 2021

Actual date on which the first participant was enrolled.

This study looks at how using a specific dental device, called the Twin Block appliance, affects the soft tissues in the jaw and neck area of patients with a particular type of dental misalignment known as Class II malocclusion and mandibular retrognathia. The focus is on young patients who are still growing and have been treated at a university's orthodontics department. The study aims to understand how this appliance can change the appearance and structure of the lower jaw and neck, which might help improve dental treatments for similar conditions in the future. This research is important as it could lead to better treatment strategies for growing children with jaw alignment issues. Participants in the study received the Twin Block appliance treatment for a year, while a control group received standard orthodontic treatment. Researchers took profile photos and X-ray images of the participants at the start and after one year to measure changes in the jaw and neck area. They used digital tools to assess specific angles and distances related to facial structure. The study involved 46 individuals divided into different groups based on their dental condition. Statistical methods were used to analyze the data and ensure the results are reliable. This comprehensive approach helps determine exactly how the Twin Block appliance impacts jaw and neck tissues during growth.

Official TitleEvaluation of Mandibular Soft Tissue Changes in Patients Using Functional Appliances
NCT06935032
Principal SponsorKonya Necmettin Erbakan Üniversitesi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 11 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
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,

Show More Criteria

3 exclusion criteria prevent from participating
previous orthodontic treatment,

presence of craniofacial anomalies involving the jaw and/or teeth,

severe facial asymmetry

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Class II Division I patients treated with the Twin Block appliance

Group II

Experimental
Class II Division II patients treated with the Twin Block appliance

Group III

Experimental
Class I patients who received fixed treatment

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Necmettin Erbakan University

Konya, Turkey (Türkiye)Open Necmettin Erbakan University in Google Maps
CompletedOne Study Center