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Search / Trial NCT06759896

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

Launched by UNIVERSITY OF MALAYA · Dec 29, 2024

Trial Information

Current as of July 12, 2025

Recruiting

Keywords

Randomized Controlled Trial Anterior Crossbite

ClinConnect Summary

This clinical trial is looking at two different treatments to help correct underbites, also known as anterior crossbites, in children aged 7 to 10 years. The treatments being compared are a protraction facemask and an upper partial fixed appliance. The main goals of the study are to see how effective each treatment is in fixing the bite, how patients feel about the treatments, and if there are any side effects or complications. To participate, children must have specific dental conditions, such as having a certain number of teeth in crossbite and good oral hygiene. Those with certain medical conditions or previous dental issues may not be eligible.

If a child joins the study, they will be randomly assigned to one of the two treatment groups and will start by having some basic records taken, like molds of their teeth and an X-ray. Throughout the treatment, they will be asked to fill out a short survey about their experience at different times. Depending on the assigned treatment, the child might need to wear a facemask for 14 hours a day or have fixed appliances placed on their teeth. Regular check-ups will be scheduled to monitor progress and help with any questions. This study not only aims to find out which treatment works better but also how children feel about their treatment journey.

Gender

ALL

Eligibility 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

About University Of Malaya

The University of Malaya, a premier research institution in Malaysia, is dedicated to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a commitment to excellence in research and education, the University collaborates with leading healthcare professionals and researchers to explore cutting-edge treatments and interventions. Its clinical trial programs focus on various health challenges, aiming to translate scientific discoveries into practical applications that benefit diverse populations. By fostering a multidisciplinary approach, the University of Malaya continues to contribute significantly to the global medical research landscape.

Locations

Kuala Lumpur, , Malaysia

Patients applied

0 patients applied

Trial Officials

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

Principal Investigator

Faculty of Dentistry, Universiti Malaya

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported