Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE)

Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE) Alt-RAMEC vs Conventional Rapid Palatal Expansion Randomized Controlled Trial -CBCT Study

The aim of this study of this study is to compare two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion using cone beam computed tomography (CBCT)

Study Overview

• Status: Active, not recruiting
• Conditions: Maxillary Protraction in Class III Adolescent After Using (MSE)
• Intervention / Treatment: Device: Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol.; Device: Maxillary skeletal expander with protraction face mask with conventional protocol

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Nasr City
    • Cairo, Nasr City, Egypt, 002
      • Mohamed Shendy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Class3 Patients suffering maxillary collapse with a skeletal background
• Patients with retrognathic maxilla.
• Patients with anterior cross-bite or incisor end-to-end relationship
• Patients with unilateral or bilateral posterior crossbite.
• Patients with no periodontal disease.
• Patients with good oral hygiene and general health.
• No systemic diseases that may affect bone quality or interfere with orthodontic treatment.
• Patients with no previous orthodontic treatment.

Exclusion Criteria:

• previous orthodontic treatment.
• Craniofacial syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (MSE) Alt-RAMEC protocol	Device: Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol.; The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by Alt-RAMEC protocol.
Active Comparator: (MSE) conventional protocol	Device: Maxillary skeletal expander with protraction face mask with conventional protocol; The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by conventional protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of maxillary protraction	protraction of maxilla using CBCT	6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• Liou EJ, Tsai WC. A new protocol for maxillary protraction in cleft patients: repetitive weekly protocol of alternate rapid maxillary expansions and constrictions. Cleft Palate Craniofac J. 2005 Mar;42(2):121-7. doi: 10.1597/03-107.1.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: maxillary protraction; Expansion; class III
• Other Study ID Numbers: 828/220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Evaluation of two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion

Drug and device information, study documents

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