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

Class III Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06452368
• Other study ID #: M04020822
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: June 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 20, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Device:
• facemask
Fixation of miniplates by four screws in the maxilla and protraction by using facemask

Locations

Country	Name	City	State
Egypt	Mohamed Adel Raghib	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cephalometric radiographs	cephalometric radiographs were analyzed and the amount of maxillary protraction, the dentoskeletal as well the soft tissue changes were evaluated	12 month