NCT07420270

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 11 Years – 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-04
• Primary completion: 2025-10-20
• Completion: 2025-12-31
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Malaysia