NCT06759896

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

Recruiting now NA Last updated 6 January 2025

What this trial tests

NA trial testing Protraction facemask in Anterior Crossbite in 24 participants. Currently enrolling.

Timeline

26 July 2024

Primary endpoint
30 December 2025

30 December 2025

Quick facts

Lead sponsor	University of Malaya
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	26 July 2024
Primary completion	30 December 2025
Estimated completion	30 December 2025
Sites	1 location across Malaysia

Drugs / interventions tested

• Protraction facemask
• Upper partial fixed appliance

Conditions studied

• Anterior Crossbite — all drugs for Anterior Crossbite →
• Class III Malocclusion in Growing Patients — all drugs for Class III Malocclusion in Growing Patients →

Sponsor

University of Malaya

Who can join

Adults 7 to 10, any sex, with Anterior Crossbite or Class III Malocclusion in Growing Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.