Actively Recruiting

Phase Not Applicable
Age: 7Years - 10Years
All Genders
Healthy Volunteers
ID06759896

Comparison of Protraction Facemask and Upper Partial Fixed Appliance for Correcting Underbite in Growing Children with Class III Malocclusion

Led by University of Malaya · Updated on 2025-01-06

24

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Comparison Between Protraction Facemask and Upper Braces for Underbite Correction in Growing Children

Who Can Participate

Age: 7Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 7 and 10 years
  • Three or four front teeth in crossbite
  • Positive overbite
  • Class III skeletal with ANB value equal to or less than 0 or retrusive maxilla
  • Crowding of teeth equal to or less than 4 mm
  • Good oral hygiene
Not Eligible

You will not qualify if you...

  • Cleft lip and palate and/or craniofacial syndrome
  • Any syndrome or medical condition
  • Participation in other orthodontic trials
  • Maxilla-mandibular planes angle greater than 35 degrees
  • Previous temporomandibular joint (TMJ) signs or symptoms
  • Lack of consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia, 50603

Actively Recruiting

Loading map...

Research Team

N

Nur Farisya S Dr Nur Farisya Shamsuddin, Master of Oral Science

L

Lau MN Associate Professor Dr Lau May Nak, Master in Orthodontics

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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/27564126