Early class III protraction facemask treatment reduces the need for orthognathic surgery: a multi-centre, two-arm parallel randomized, controlled trial.
Nicky Mandall, Richard Cousley, Andrew DiBiase...
https://pubmed.ncbi.nlm.nih.gov/27564126Actively Recruiting
Led by University of Malaya · Updated on 2025-01-06
24
Participants Needed
1
Research Sites
74 weeks
Total Duration
Researchers are evaluating the effectiveness of two orthodontic treatments—the protraction facemask and the upper partial fixed appliance—in correcting anterior crossbite in children aged 7 to 10 years with class III malocclusion. The study aims to compare success rates in correcting the crossbite, differences in dental, skeletal, and soft tissue outcomes, patient perceptions of each treatment, and the incidence of any adverse effects or appliance breakages. Participants are randomly assigned to receive either the protraction facemask combined with rapid maxillary expansion or the upper partial fixed appliance. The protraction facemask includes a forehead and chin pad connected by a steel rod, worn with elastics for 14 to 16 hours daily, typically at night, while the upper partial fixed appliance uses specific brackets, molar bands, and archwires to correct the bite. Treatment lasts approximately 6 to 9 months with checkups every six weeks. Before treatment, study models and lateral cephalometric X-rays are taken to assess skeletal and soft tissue structures. Participants will complete a Child Perceptions Questionnaire at four points: before treatment, and at 3, 6, and 9 months into treatment, to capture their experiences. Researchers will monitor skeletal, dental, and soft tissue changes from treatment start to end. After treatment, appliances are removed without retainers, as corrected overjet is considered stable. The entire study includes assessments, treatments, and follow-ups over about 9 months.
CONDITIONS
Comparison Between Protraction Facemask and Upper Braces for Underbite Correction in Growing Children
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Total: 1 location
1
Faculty of Dentistry, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
Actively Recruiting
N
Nur Farisya S Dr Nur Farisya Shamsuddin, Master of Oral Science
L
Lau MN Associate Professor Dr Lau May Nak, Master in Orthodontics
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nicky Mandall, Richard Cousley, Andrew DiBiase...
https://pubmed.ncbi.nlm.nih.gov/27564126