AzTrials
AzTrials

TreatmentNCT07420270

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

A study testing Mandibular Advancement Aligner in people with Treatment and Growth Modification, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 11 to 16 years
Conditions the study is for
Treatment, Growth Modification
What is being tested?
Mandibular Advancement Aligner
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteMalaysia
Study dates
4 Jul 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)
Show all 9Show fewer
  • Increased overbite by more than 30%
  • Molar relationship by more than ½ unit Class II bilaterally
  • Mild to moderate crowding

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Faculty of Dentistry

    Kuala Lumpur, Kuala Lumpur, 50603

Other trials in Malaysia

About this study

Official title: Effects of Mandibular Advancement Aligners in Growth Modification of Class II Division 1 Malocclusion: A Randomised Controlled Trial

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?

Read more

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.

Being tested
Mandibular Advancement Aligner
Keywords
Class II Division 1 malocclusion, Mandibular advancement aligners, Twin Block appliance
Medical subject headings
Malocclusion, Angle Class II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mandibular Advancement AlignerDevice

    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.

Study groups in NCT07420270
Study groupRoleWhat they receive
Mandibular Advancement Aligner with bite openingExperimentalActive intervention, AngelAlign A6 system
Receives: Device: Mandibular Advancement Aligner
Mandibular Advancement Aligner without bite openingExperimentalActive intervention, Graphy system
Receives: Device: Mandibular Advancement Aligner
Twin-block applianceExperimentalControl group for the intervention
Receives: Device: Mandibular Advancement Aligner

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of treatment at 6 months

Secondary outcomes (1)

  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.

    The score of CPQ11-14 is as follows: "never" = 1, "hardly ever" = 2, "sometimes" = 3, "fairly often" = 4, and "very often" = 5.

    Measured: From enrollment to the end of treatment at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start4 Jul 2024
  3. Primary completion20 Oct 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07420270
Sponsor's protocol ID
DF CD 2421/0057 (P)
Status last verified
Jul 2024
First submitted
11 Jan 2026
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

  • 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.

    PubMed 12970656

  • 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.

    PubMed 37831020

  • 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.

    PubMed 39275829

  • 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.

    PubMed 38375387

  • 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.

    PubMed 40008555

  • 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.

    PubMed 33719479

Questions about this trial

What is this clinical trial studying?

A study testing Mandibular Advancement Aligner in people with Treatment and Growth Modification, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the skeletal, dentoalveolar, and soft tissue after 6 months as assessed by Lateral Cephalometric values (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07420270, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in