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

NCT06759896 | Recruiting DMC

• 1 other identifier: DF CD 2419/0055 (P)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 1.Making moulds of their teeth to create study models
2. 2.Taking a side-view X-ray of their head (called a lateral cephalometric radiograph)

Conditions

Anterior Crossbite; Class III Malocclusion in Growing Patients

Keywords

Randomized controlled trial; anterior crossbite

Outcome Measures

Primary Outcomes (6)

• 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

  Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months

• 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.

  Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months

• 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

  Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months

• 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

  Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months

• Soft tissue changes

  From lateral cephalometric • Nasolabial angle (°) - an improvement in naso labial angle near to 90 - 110 degree shows good treatment outcome

  Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months

• Soft tissue changes

  From lateral cephalometric * Upper lip to E-line (in millimetres) - a decrease in millimetres to E-line shows good treatment outcome, less retrusive upper lips * Lower lip to E-line (in millimetres) - an improvement near to average value shows good treatment outcome (Milimetres can be increase or decrease depends on patients biting with mandibular displacement or not), averagely position lower lips

  Before start treatment (issue appliance) and the end of treatment (after debond appliance) at 6 months to 9 months

Secondary Outcomes (2)

• Patients perception

  From issuance appliance date to the end of treatment at 3 months, 6 months and after appliance removal

• Adverse effects

  From issuance appliance date to the end of treatment at 3 months, 6 months and after appliance removal

Study Arms (2)

Arm 1 - Protraction facemask

ACTIVE COMPARATOR

Patients assigned to Arm 1 will utilize the Petit protraction facemask, in conjunction with a rapid maxillary expansion (RME).

Device: Protraction facemask

Arm 2 - Upper partial fixed appliance

ACTIVE COMPARATOR

Patient allocated in Arm 2 will use upper partial fixed appliance / 2 by 4 appliance on their for upper incisors and molar band on upper 1st molars

Device: Upper partial fixed appliance

Interventions

Protraction facemask DEVICE

Patients 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.

Arm 1 - Protraction facemask

Upper partial fixed appliance DEVICE

Upper 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) .

Arm 2 - Upper partial fixed appliance

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Amount of crowding equal to or less than 4 mm
• Good oral hygiene

You may not qualify if:

• 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
• Previous history of TMJ signs or symptoms
• Lack of consent

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (1)

• Mandall N, Cousley R, DiBiase A, Dyer F, Littlewood S, Mattick R, Nute SJ, Doherty B, Stivaros N, McDowall R, Shargill I, Worthington HV. Early class III protraction facemask treatment reduces the need for orthognathic surgery: a multi-centre, two-arm parallel randomized, controlled trial. J Orthod. 2016 Sep;43(3):164-75. doi: 10.1080/14653125.2016.1201302.

  PMID: 27564126 BACKGROUND

Related Links

• A leaflet from British Orthodontic Society website

Study Officials

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

  Faculty of Dentistry, Universiti Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+60102586961; farisya87@gmail.com

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

CONTACT

+60126117566; minalau@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: A randomized controlled trial with 2 arm parallel

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 6, 2025
• Study Start: July 26, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)