An interventional study of Mandibular Advancement Appliance (Invisalign MA) and Activator Appliance in Mandibular Retrognathia, sponsored by Batman University. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Batman University · Not applicable, Interventional, and Treatment
The aim of this study is to compare the effectiveness of two different orthodontic treatment methods used in patients with skeletal Class II malocclusion, a condition in which the lower jaw is positioned backward. Approximately 80% of Class II malocclusions are due to mandibular retrusion. Therefore, functional appliances that stimulate mandibular growth in growing individuals have been widely used in orthodontics for many years.
In recent years, clear aligner systems have become increasingly popular in orthodontic practice. A mandibular advancement feature was recently integrated into these aligners, allowing for simultaneous tooth alignment and forward positioning of the lower jaw. In this study, the newly developed Mandibular Advancement Appliance (MAA), based on clear aligners, will be compared to the traditional functional appliance known as the Activator.
Who Can Participate in the Study? Children with retrusive lower jaws who are in the growth and development period Individuals with no prior orthodontic treatment Patients with specific levels of dental protrusion (overjet) Those with good general health and no contraindications for CBCT imaging What Will the Treatment Process Involve?
Participants will be randomly assigned to one of three groups:
MAA group (clear aligners with mandibular advancement) Activator group (traditional removable appliance) Control group (no treatment, only observation) The active treatment period will last approximately 7-8 months, followed by a retention phase. All patients will be monitored regularly, and strict adherence to appliance use will be expected.
How Will the Outcomes Be Assessed? Before and after the treatment period, participants will undergo cone-beam computed tomography (CBCT) scans to obtain detailed three-dimensional images of the jaws. These images will be analyzed to evaluate volumetric changes. All measurements will be performed by a trained orthodontic specialist using dedicated software.
Potential Benefits for Participants:
Participants will receive close clinical monitoring throughout the study period. The use of advanced imaging technologies may support the development of more effective and individualized treatment plans.
Safety and Confidentiality:
This study has received ethical approval and will be conducted in accordance with relevant data protection and research ethics standards. All personal data will be kept confidential. Written informed consent will be obtained from all participants and/or their legal guardians.
26 studies on the registry are indexed under Micrognathism; 7 are open to participants now.
This study's enrollment of 55 is above the median of 24 across 22 interventional studies indexed under Micrognathism.
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Exclusion Criteria:
Patients receive orthodontic treatment using clear aligners (Invisalign) with integrated mandibular advancement features (MAA). Advancement is performed in 2 mm increments every 8 weeks over \~8 months.
Device: Mandibular Advancement Appliance (Invisalign MA)
Patients receive traditional removable functional appliance therapy (Activator) for \~7 months.
Device: Activator Appliance
Patients receive no orthodontic treatment but are monitored for the same duration as the treatment groups.
Clear aligner system with integrated buccal precision wings to posture the mandible forward. Advancement protocol: 2 mm increments every 8 weeks. Total active treatment duration: \~8.15 months, followed by retention phase. Patients instructed to wear aligners ≥20 h/day, removing only for eating and oral hygiene.
Traditional removable functional appliance fabricated on a standardized bite registration. Patients instructed to wear appliance 24 h/day except during meals and sports. Total active treatment duration: \~7.15 months, followed by retention phase.
Change in mandibular volume (mm³)
Mandibular volume change will be measured using CBCT scans analyzed via Mimics software. The MAA and Activator groups will be compared to evaluate treatment effects.
Time frame: Baseline and post-treatment (~8 months)
Plan to share: No
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Batman University