Effects of Mandibular Advancement Aligners in Growth Modification of Class II Division 1 Malocclusion: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Malaya
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change from Baseline in the skeletal, dentoalveolar, and soft tissue after 6 months as assessed by Lateral Cephalometric values
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Mandibular Advancement Aligner with bite opening
Active intervention, AngelAlign A6 system
Intervention: Mandibular Advancement Aligner (Device)
Mandibular Advancement Aligner without bite opening
Active intervention, Graphy system
Intervention: Mandibular Advancement Aligner (Device)
Twin-block appliance
Control group for the intervention
Intervention: Mandibular Advancement Aligner (Device)
Outcomes
Primary Outcomes
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
- 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)