Tow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study

January 3, 2022 updated by: Abdallah EL sayed Mohamed Hassan, Al-Azhar University

Comparison of Tow Maxillary Hybrid Expanders -Perpendicular Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study

in this study i will use to different designs of t maxillary hybrid expanders that consists of HYREX supported with tow miniscrews to treat the collapsed maxilla in Yonge adolescents

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

the maxilla is expanded by tow diffrent designs of maxillary hybrid expanders

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Egypt
      • Cairo, Egypt, 11311
        • Al Azhar University

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Medically free male or female patients
  2. Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite.
  3. The patient should have no missing teeth except third molars.
  4. Age ranged from 12 to 18 years old.
  5. The patient should have a good gingival condition.
  6. The patient should have a good periodontal condition.

Exclusion Criteria:

1-hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem.

-

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: group (1)
tow perpendicular miniscrews supported hybrid expanders
Device: hybrid expanders
tow maxillary hybrid expanders supported anteriorly with tow miniscrews
Experimental: group (2)
tow angulated miniscrews supported hybrid expanders
Device: hybrid expanders
tow maxillary hybrid expanders supported anteriorly with tow miniscrews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in maxillary width
Time Frame: 12 weeks following end of treatment
millimeter
12 weeks following end of treatment

Collaborators and Investigators

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

Sponsor

Al-Azhar 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 (Actual)

July 10, 2021

Primary Completion (Anticipated)

June 10, 2023

Study Completion (Anticipated)

October 14, 2023

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 628/3133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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