Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients (ALT-RAMEC)

April 19, 2022 updated by: Andrew Wafdy Nan Demian, Cairo University

Intraoral Maxillary Protraction Technique With ALT-RAMEC ( Alternate Rapid Maxillary Expansion and Constriction) Protocol Versus Facemask With Maxillary Expansion in Treating Class III Growing Patients With Maxillary Deficiency: A Randomized Clinical Trial

The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Delivering hybrid expander supported by 2 miniscrews in palate to perform Alt-RAMEC protocol for 9 weeks then intervention group will start protraction using class iii elastics on modified lingual arch with hooks in canine area and 2 miniscrews labially between lower lateral and canine while control group use face mask for protraction of maxilla

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Manial
      • Cairo, Manial, Egypt, 11553
        • Recruiting
        • Faculty of Oral and Dental Medicine - Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female Growing Patient ( CVM2-CVM3 )
  • Skeletal class III (ANB ≤ 0 , A-NV≤ -2 and wits appraisal < -0.3mm)
  • Erupted upper and lower first permanent molars and permanent incisors
  • Reverse overjet up to -4 mm

Exclusion Criteria:

  • History of previous orthodontic treatment
  • Cleft lip/palate patients
  • Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
  • Patients with syndromes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoral Protraction Technique
using intraoral appliance composed of modified lingual arch and miniscrews for indirect anchorage for maxillary protraction after Alt-RAMEC protocol using hybrid expander
Device: Intraoral protraction device
Use of modified lingual arch with indirect anchorage from screws between lower lateral incisor and lower canine to protract maxilla after ALT-RAMEC protocol
Active Comparator: Extraoral Protraction Technique
using facemask for maxillary protraction after ALT-RAMEC protocol
Device: Extraoral protraction device
Facemask which is an extraoral appliance used for maxillary protraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxillary skeletal changes
Time Frame: 8 months
using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA)
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mandibular skeletal changes
Time Frame: 8 months
using lateral cephalometric x-ray to measure mandibular skeletal changes using angular measurements in degrees (SNB)
8 months
Maxillary and Mandibular dental changes
Time Frame: 8 months
using lateral cephalometric x-ray to measure changes using angular measurements in degrees (U1/Palatal plane ,L1/Mandibular plane)
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Andrew Demian, BDS, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ASR1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Orthodontic Appliance Complication

Clinical Trials on Intraoral protraction device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe