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

NCT07420270 | Completed

• 1 other identifier: DF CD 2421/0057 (P)
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment; Growth Modification

Keywords

Class II Division 1 malocclusion; Mandibular advancement aligners; Twin Block appliance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 6 months

Study Arms (3)

Mandibular Advancement Aligner with bite opening

EXPERIMENTAL

Active intervention, AngelAlign A6 system

Device: Mandibular Advancement Aligner

Mandibular Advancement Aligner without bite opening

EXPERIMENTAL

Active intervention, Graphy system

Device: Mandibular Advancement Aligner

Twin-block appliance

EXPERIMENTAL

Control group for the intervention

Device: Mandibular Advancement Aligner

Interventions

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.

Mandibular Advancement Aligner with bite opening; Mandibular Advancement Aligner without bite opening; Twin-block appliance

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (7)

• 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.

  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.

  PMID: 12970656 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.

  PMID: 37831020 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.

  PMID: 39275829 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.

  PMID: 38375387 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.

  PMID: 40008555 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.

  PMID: 33719479 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Wey Mang Chek, Associate Prof

  Faculty of Dentistry, Universiti Malaya

  STUDY CHAIR

• Nurul Aliaa Ahmad Fauzi, Dr

  Faculty of Dentistry, Universiti Malaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: February 19, 2026
• Study Start: July 4, 2024
• Primary Completion: October 20, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)