Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients

to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients

Study Overview

• Status: Completed
• Conditions: Class III Malocclusion
• Intervention / Treatment: Device: facemask

Detailed Description

A randomized controlled clinical trial was adopted in this study. A total of 20 growing Class III patients were selected from patients seeking orthodontic treatment. The participants were recruited from the department of Orthodontics at Faculty of Dentistry, Mansoura University. No active advertisement was used for participant recruitment, and instead, a convenience sample was formed. Prior to participating in the study, the purpose of the study was explained to the parents of the children and informed consents and assents were obtained according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry, Mansoura University

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Mohamed Adel Raghib

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Growing patients with age ranged between 8-13 years old.
• Patients should have examination: Class III malocclusion due to maxillary retrusion as verified by clinical and radiographic examination; SNA <79 and ANB angle < -1.
• Good likelihood of recall availability.

Exclusion Criteria:

• Vertical skeletal mal relationship.
• History of previous orthodontic/orthopedic treatment.
• Bad habits that may jeopardize the appliance.
• Patients with systemic diseases
• Congenital deformities such as cleft lip and/or palate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palatal protraction; Palatal plate assisted with facemask	Device: facemask; Fixation of miniplates by four screws in the maxilla and protraction by using facemask
Active Comparator: Buccal protraction; Buccal plate assisted with facemask	Device: facemask; Fixation of miniplates by four screws in the maxilla and protraction by using facemask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cephalometric radiographs	cephalometric radiographs were analyzed and the amount of maxillary protraction, the dentoskeletal as well the soft tissue changes were evaluated	12 month

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: M04020822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No