Study of The Effects of Mandibular Advancement Aligners in Treating Children With Class II Division 1 Malocclusion

February 11, 2026 updated by: University of Malaya

Effects of Mandibular Advancement Aligners in Growth Modification of Class II Division 1 Malocclusion: A Randomised Controlled Trial

The goal of this clinical trial is to learn the effects of Mandibular Advancement Aligner in growth modification of children with Class II Division 1 malocclusion. It will also learn about the psychosocial impact of the participants during the process. The main questions it aims to answer are:

Is there a difference in the skeletal, dental and soft tissue effects of treatments using the mandibular advancement (MA) aligners?

What is the patient's perception on the treatment outcome and is there any difference between the group treated with the mandibular advancement (MA) aligners and the control group?

Is there any tooth movements can be assess during the treatments using the mandibular advancement (MA) aligners?

Participants will:

Participants will be randomly assigned to three groups: mandibular advancement (MA) aligners with vertical bite opening, mandibular advancement (MA) aligners without vertical bite opening, and twin-block appliances.

The intervention groups will receive specific instructions on how to wear the appliance accordingly.

The trial will span an estimated 6 months for each sample, during which monthly follow-up visits will be carried out to monitor the changes and compliance of the appliance.

The primary outcome measures include the measurements in the lateral cephalometric, changes in the intraoral assessment, and questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • Faculty of dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cervical Vertebrae Maturity: CS3-CS4 (Growing participants)
  • Chronological age: 10-14 years old (Female), 12-16 years old (Male)
  • Average or reduced lower anterior facial height (LAFH<57%)
  • Mild to moderate skeletal Class II (4°<ANB<9°)
  • Retrognathic mandible (SNB<78°)
  • Increased overjet (7mm≤OJ≤11mm)
  • Increased overbite by more than 30%
  • Molar relationship by more than ½ unit Class II bilaterally
  • Mild to moderate crowding

Exclusion Criteria:

  • Participant with an anterior open bite
  • Participant with syndromic dentofacial anomalies
  • Participant with a previous history of orthodontic intervention
  • Participant with signs and symptoms of temporomandibular disorder
  • Participant with severe facial asymmetry (Deviation ≥4mm)
  • Not being consented to by both parents and participants
  • Poor quality of pre-treatment Lateral Cephalometric records
  • Participant with mental or physical disabilities affecting the ability to wear an appliance

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mandibular Advancement Aligner with bite opening
Active intervention, AngelAlign A6 system
Device: Mandibular Advancement Aligner
Device use as growth modification in children with Class II Division 1 malocclusion. The twin-block appliance have been used for a long time, whereas in recent years the aligner technology have come out with new design of the Mandibular Advancement Aligner.
Experimental: Mandibular Advancement Aligner without bite opening
Active intervention, Graphy system
Device: Mandibular Advancement Aligner
Device use as growth modification in children with Class II Division 1 malocclusion. The twin-block appliance have been used for a long time, whereas in recent years the aligner technology have come out with new design of the Mandibular Advancement Aligner.
Experimental: Twin-block appliance
Control group for the intervention
Device: Mandibular Advancement Aligner
Device use as growth modification in children with Class II Division 1 malocclusion. The twin-block appliance have been used for a long time, whereas in recent years the aligner technology have come out with new design of the Mandibular Advancement Aligner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the skeletal, dentoalveolar, and soft tissue after 6 months as assessed by Lateral Cephalometric values
Time Frame: From enrollment to the end of treatment at 6 months
Comparing the value of linear and angular measurements of Lateral Cephalometric at baseline and after 6 months.
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in the participants' perceptions of oral health-related quality of life in Class II Division 1 malocclusion treatment at 6 months as assessed by the score of CPQ11-14 questionnaire.
Time Frame: From enrollment to the end of treatment at 6 months
The score of CPQ11-14 is as follows: "never" = 1, "hardly ever" = 2, "sometimes" = 3, "fairly often" = 4, and "very often" = 5.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Study Chair: Wey Mang Chek, Associate Prof, Faculty of Dentistry, Universiti Malaya
  • Study Director: Nurul Aliaa Ahmad Fauzi, Dr, Faculty of Dentistry, Universiti Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2024

Primary Completion (Actual)

October 20, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF CD 2421/0057 (P)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to participant information was restricted to research team members directly involved in data collection, analysis, and management. Furthermore, any published or disseminated findings were presented in aggregate form to prevent the identification of individual participants. Before the data collection, participants were informed about the confidentiality measures in place and were required to provide informed consent for their participation, including the use and storage of their data. Compliance with data protection regulations and ethical guidelines was ensured throughout the study to safeguard the confidentiality and privacy of the participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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