Comparison Between Protraction Facemask and Upper Braces for Underbite Correction in Growing Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-10
SponsorUniversity of Malaya
About this trial
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
This trial accepts healthy volunteersQualifiers
Age group between 7 to 10 years
Three or four incisors in crossbite
Positive overbite
Class III skeletal with ANB equal to or less than 0 or retrusive maxilla
Disqualifiers
Cleft lip and palate and/or craniofacial syndrome
Patients with syndromes or medical condition
Subjects involved in any other orthodontic trials
A maxilla-mandibular planes angle greater than 35 degree
Trial design
Design model
Parallel
Treatments tested in this trial
Protraction facemask
DevicePatients assigned to intervention 1 will utilize the Petit protraction facemask, in conjunction with a rapid maxillary expansion (RME). This facemask consists of a forehead pad and chin pad linked by a sturdy steel support rod.
Upper partial fixed appliance
DeviceUpper partial fixed appliance / 2 by 4 appliance will be used in this study by using bracket set (119-142 Unitek™ Gemini Bracket MBT™ U/L 5x5 0T-Cuspid 3Hk) with molar bands (3M™ Victory Series™ First Molar Bands) or buccal tubes (3M™ Victory Series™ Superior Fit Buccal Tubes) and upper nickel titanium archwires (3M™ Unitek™ Nitinol Heat-activated Archwire) and upper stainless steel archwires (3M™ Unitek™ Permachrome Standard Archwire) .
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - Protraction facemaskActive comparator 1 intervention
Group B: Arm 2 - Upper partial fixed applianceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Skeletal changes
From Lateral cephalometric 1\. Skeletal changes in unit degree * SNA (°) - an increase at the end of treatment shows good treatment outcome * SNB (°) - no or minimal increase at the end of treatment shows good treatment outcome * ANB (°) - an increase at the end of treatment shows good treatment outcome * MMPA (°) - a minimal increase at the end of treatment is expected but not more than 35 degree shows a good treatment outcome * Upper incisor to maxillary plane angle (°) - an increase at the end of treatment shows good treatment outcome * Lower incisor to mandibular plane angle (°) - no changes or insignificant increase at the end of treatment shows good treatment outcome * Interincisal angle (°) - decrease at the end of treatment shows good treatment outcome
Time frame
Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months2
Skeletal changes
From lateral cephalometric \- Increase or decrease in lower facial height (in percentage). Expected to have an increase after treatment but not more than 55 percent.
Time frame
Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months3
Dental changes
Study model to measure dental changes * Overjet (in milimeter) - an increase OJ at the end of treatment shows good treatment outcome * Overbite (in milimeter/ percentage) - a positive incisal overlap shows good treatment outcome for stability
Time frame
Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months4
Dental changes
Study model to measure canine and molar relationship changes based on British Standard Institution classification (Class I; Class II - 1/4 , 1/2, 3/4 , full ; Class III - 1/4 , 1/2, 3/4 , full) * Canine relationship - an improvement from Class III canine to Class I canine shows good treatment outcome * Molar relationship - an improvement from Class III molar to Class I molar shows good treatment outcome
Time frame
Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 monthsSecondary outcomes
1
Patients perception
Child Perception Questionnaire 8-10 will be used in this study to assess oral health-related quality of life scores for all participants at this time point: * before treatment, * 3 months after treatment * 6 months after treatment (if treatment not yet completed) * post- treatment A reduction/ decrease in the score at the end of treatment shows an improvement in oral health-related quality of life after the treatment is done.
Time frame
From issuance appliance date to the end of treatment at 3 months, 6 months and after appliance removal2
Adverse effects
The number of breakages, injuries or any other adverse effects that happened throughout the treatment time will be recorded
Time frame
From issuance appliance date to the end of treatment at 3 months, 6 months and after appliance removalSponsors and contacts
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Source ClinicalTrials.gov