NCT06759896 Comparison Between Protraction Facemask and Upper Braces for Underbite Correction in Growing Children
| NCT ID | NCT06759896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Malaya |
| Condition | Anterior Crossbite |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-07-26 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-07-26 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare the effectiveness of a protraction facemask and upper partial fixed appliance in correcting anterior crossbite in growing children with class III malocclusion. It will also learn about the patients perceptions of these treatments. The main questions it aims to answer are: i. What is the rate of success in achieving anterior crossbite correction with the protraction facemask and upper partial fixed appliance? ii. Are there any significant differences in the dental, skeletal and soft tissue outcomes between the two treatment groups? iii. What are the patient's perceptions associated with each treatment modality received. iv. What is the incidence of adverse effects or complications and breakages associated with each treatment modality? Participants will be randomly assigned to one of two groups: 1) protraction facemask; or 2) upper partial fixed appliance. After investigators decide which group participants will be in, investigators will take some standard records for the study before starting the treatment. These records include: 1. Making moulds of their teeth to create study models 2. Taking a side-view X-ray of their head (called a lateral cephalometric radiograph) Additionally, the participant will need to fill out a quick 5-minute survey called the Child Perceptions Questionnaire 8-10 (CPQ8-10). It has 25 short questions. The participant will do this survey at four different times: 1) before starting the treatment; 2) 3 months into the treatment; 3) 6 months into the treatment; and 4) after the treatment is done. Investigators will set up appointments for the treatment based on the type assigned. Once the treatment starts, investigators will see the participant every six weeks until it is finished. If the participant gets a protraction facemask, investigators will put a fixed expander appliance in the mouth at the palate. Investigators will teach them how to activate the appliance once a day for seven days. Afterwards, the participant will use the protraction facemask with elastics connecting the appliance in the mouth and the protraction facemask. The participant must wear it for 14 hours a day, at night. If the participants gets an upper fixed partial appliance, investigators will bond upper fixed appliances in the mouth. Investigators will teach the child how to clean the appliance and their mouth to avoid any potential problems or side effects during the treatment.
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
Contact & Investigator
Nur Farisya S Dr Nur Farisya Shamsuddin, Master of Oral Science
✉ farisya87@gmail.com📞 +60102586961
Nur Farisya S Dr Nur Farisya Shamsuddin, Master in Oral Science
PRINCIPAL INVESTIGATOR
Faculty of Dentistry, Universiti Malaya
Frequently Asked Questions
Who can join the NCT06759896 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 10 Years, studying Anterior Crossbite. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06759896 currently recruiting?
Yes, NCT06759896 is actively recruiting participants. Contact the research team at farisya87@gmail.com for enrollment information.
Where is the NCT06759896 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia.
Who is sponsoring the NCT06759896 clinical trial?
NCT06759896 is sponsored by University of Malaya. The principal investigator is Nur Farisya S Dr Nur Farisya Shamsuddin, Master in Oral Science at Faculty of Dentistry, Universiti Malaya. The trial plans to enroll 24 participants.