Comparing two methods for correcting underbites in children
Comparison Between Protraction Facemask and Upper Partial Fixed Appliance for Early Class III Intervention: a Randomized Controlled Trial
This study is testing two different ways to fix underbites in kids aged 7 to 10 to see which method works better and how the kids feel about it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 7 Years to 10 Years |
| Sex | All |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Kuala Lumpur, Kuala Lumpur) |
| Trial ID | NCT06759896 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of a protraction facemask and an upper partial fixed appliance in correcting anterior crossbite in growing children with class III malocclusion. Participants aged 7 to 10 years will be randomly assigned to one of the two treatment groups. The study will assess the success rates of each method, differences in dental and skeletal outcomes, patient perceptions, and any adverse effects associated with the treatments. Comprehensive orthodontic assessments and imaging will be conducted to evaluate the results.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 10 years with anterior crossbite and class III malocclusion.
Not a fit: Patients with cleft lip and palate, craniofacial syndromes, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for correcting underbites in children, leading to improved dental health and quality of life.
How similar studies have performed: Previous studies have shown varying success rates for similar orthodontic interventions, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age group between 7 to 10 years 2. Three or four incisors in crossbite 3. Positive overbite 4. Class III skeletal with ANB equal to or less than 0 or retrusive maxilla 5. Amount of crowding equal to or less than 4 mm 6. Good oral hygiene Exclusion Criteria: 1. Cleft lip and palate and/or craniofacial syndrome 2. Patients with syndromes or medical condition 3. Subjects involved in any other orthodontic trials 4. A maxilla-mandibular planes angle greater than 35 degree 5. Previous history of TMJ signs or symptoms 6. Lack of consent
Where this trial is running
Kuala Lumpur, Kuala Lumpur
- Faculty of Dentistry, Universiti Malaya — Kuala Lumpur, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Nur Farisya S Dr Nur Farisya Shamsuddin, Master in Oral Science — Faculty of Dentistry, Universiti Malaya
- Study coordinator: Nur Farisya S Dr Nur Farisya Shamsuddin, Master of Oral Science
- Email: farisya87@gmail.com
- Phone: +60102586961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.