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Completed

NCT Number: NCT07420270

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

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.

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Key information

Conditions

Treatment Growth Modification Malocclusion Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Kuala Lumpur, 50603, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    Comparing the value of linear and angular measurements of Lateral Cephalometric at baseline and after 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.

    Time frame: From enrollment to the end of treatment at 6 months

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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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