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

NCT07420270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Treatment
  • Growth Modification

Interventions

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.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Wey Mang Chek, Associate Prof · Faculty of Dentistry, Universiti Malaya

  • Nurul Aliaa Ahmad Fauzi, Dr · Faculty of Dentistry, Universiti Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-04
Primary Completion
2025-10-20
Completion
2025-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07420270 on ClinicalTrials.gov