An interventional study of Mandibular Advancement Aligner in Treatment and Growth Modification, sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to participants aged 11 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
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.
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's enrollment of 21 is below the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
Active intervention, AngelAlign A6 system
Device: Mandibular Advancement Aligner
Active intervention, Graphy system
Device: Mandibular Advancement Aligner
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.
Change from Baseline in the skeletal, dentoalveolar, and soft tissue after 6 months as assessed by Lateral Cephalometric values
Comparing the value of linear and angular measurements of Lateral Cephalometric at baseline and after 6 months.
Time frame: From enrollment to the end of treatment at 6 months
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.
The score of CPQ11-14 is as follows: "never" = 1, "hardly ever" = 2, "sometimes" = 3, "fairly often" = 4, and "very often" = 5.
Time frame: From enrollment to the end of treatment at 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
Ran from Jul 2024 to primary completion in Oct 2025, 15 months.
Of 86 non-industry interventional studies with no phase under Malocclusion, Angle Class II, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's 15 months is close to that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 11 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class II →