Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandibular Advancement Aligner with bite opening | Experimental | Active intervention, AngelAlign A6 system |
|
| Mandibular Advancement Aligner without bite opening | Experimental | Active intervention, Graphy system |
|
| Twin-block appliance | Experimental | Control group for the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular Advancement Aligner | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wey Mang Chek, Associate Prof | Faculty of Dentistry, Universiti Malaya | Study Chair |
| Nurul Aliaa Ahmad Fauzi, Dr | Faculty of Dentistry, Universiti Malaya | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Salek, F., Benyahia, H., & Zaoui, F. (2025). Comparative efficacy of mandibular advancement aligners and conventional orthopedic appliances in treating Class II malocclusion: A systematic review. Discover Medicine, 2. | ||
| 12970656 | Background | O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524. | |
| 37831020 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 26, 2025 | Jan 18, 2026 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008312 | Malocclusion, Angle Class II |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
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 (controlled group).
Not provided
Not provided
Not provided
|
| Background |
| Hosseini HR, Ngan P, Tai SK, Andrews LJ 2nd, Xiang J. A comparison of skeletal and dental changes in patients with a Class II relationship treated with clear aligner mandibular advancement and Herbst appliance followed by comprehensive orthodontic treatment. Am J Orthod Dentofacial Orthop. 2024 Feb;165(2):205-219. doi: 10.1016/j.ajodo.2023.08.015. Epub 2023 Oct 10. |
| 39275829 | Background | He J, Hu L, Yuan Y, Wang P, Zheng F, Jiang H, Li W. Comparison between clear aligners and twin-block in treating class II malocclusion in children: a retrospective study. J Clin Pediatr Dent. 2024 Sep;48(5):125-130. doi: 10.22514/jocpd.2023.070. Epub 2024 Sep 3. |
| 38375387 | Background | Al Subaie H, Alturki G, Alsulaimani F, Ghoneim S, Baeshen H. Assessment of dental, skeletal, and soft tissue changes following mandibular advancement with Invisalign in skeletal Class II. Saudi Dent J. 2024 Jan;36(1):66-71. doi: 10.1016/j.sdentj.2023.09.005. Epub 2023 Sep 14. |
| 40008555 | Background | Ghorbani M, Mousavi SA, Bardideh E, Saeedi P, Shahnaseri S, Shafaee H, Akyalcin S. The Effectiveness of Functional Clear Aligners for Class II Correction in Growing Patients: A Systematic Review and Meta-Analysis. Orthod Craniofac Res. 2025 Aug;28(4):577-592. doi: 10.1111/ocr.12908. Epub 2025 Feb 26. |
| 33719479 | Background | Caruso S, Nota A, Caruso S, Severino M, Gatto R, Meuli S, Mattei A, Tecco S. Mandibular advancement with clear aligners in the treatment of skeletal Class II. A retrospective controlled study. Eur J Paediatr Dent. 2021;22(1):26-30. doi: 10.23804/ejpd.2021.22.01.05. |