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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06452368
Other study ID # M04020822
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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