Actively Recruiting

Phase Not Applicable
Age: 7Years - 10Years
All Genders
Healthy Volunteers
NCT06759896

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

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

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.

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

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia, 50603

Actively Recruiting

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Research Team

N

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

CONTACT

L

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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