Study of The Effects of Mandibular Advancement Aligners in Treating Children With Class II Divisi… (NCT07420270) | Clinical Trial Compass
CompletedNot Applicable
Study of The Effects of Mandibular Advancement Aligners in Treating Children With Class II Division 1 Malocclusion
Malaysia21 participantsStarted 2024-07-04
Plain-language 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.
Who can participate
Age range
11 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the skeletal, dentoalveolar, and soft tissue after 6 months as assessed by Lateral Cephalometric values
Timeframe: From enrollment to the end of treatment at 6 months