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

Sponsor
Al-Azhar University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05489302
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease Intervention/Treatment Phase
  • Device: Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol.
  • Device: Maxillary skeletal expander with protraction face mask with conventional protocol
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 20, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jan 20, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. amount of maxillary protraction [6 months]

    protraction of maxilla using CBCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mohamed Shendy Cairo Nasr City Egypt 002

Sponsors and Collaborators

  • Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Abdelrhman Shendy Abdelrhman, lecturer, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05489302
Other Study ID Numbers:
  • 828/220
First Posted:
Aug 5, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Abdelrhman Shendy Abdelrhman, lecturer, Al-Azhar University
Expansion
maxillary protraction
class III

Study Results

No Results Posted as of Aug 10, 2022