Clinical Trial

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

Completed
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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.
Trial Details
NCT Number NCT07420270
Lead Sponsor University of Malaya
Conditions Treatment, Growth Modification
Enrollment 21 participants
Start Date 2024-07-04
Primary Completion 2025-10-20 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-19