Effects of Skeletally Anchored Maxillary Expander Via Two Approaches of Microosteoperforations

June 22, 2022 updated by: Amgad Ragab Alawady kaoah, Al-Azhar University

Dento-skeletal Effects of Skeletally Anchored Maxillary Expander Assisted With Two Approaches of Microosteoperforations

study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Dento-skeletal effects of skeletally anchored maxillary expander assisted with two approaches of microosteoperforations.

Study Type

Interventional

Enrollment (Anticipated)

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
        • Al-Azhar univesity

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

18 years to 22 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients should satisfy the following criteria:-

    1. An age range from 18-22.
    2. Transverse maxillary deficiency.
    3. Crossbite (unilateral or bilateral)
    4. No previous orthodontic treatment.
    5. Good oral and general health.
    6. No systemic disease/ medication that could interfere with OTM.

Exclusion Criteria:

  1. History of systemic and medical illness.
  2. History of extraction of permanent teeth.
  3. Previos orthodontic treatment.
  4. Poor oral hygiene or periodontally compromised patient.
  5. Patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.

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
Active Comparator: skeletal expander with microosteoperforation in mid palatine
group1.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture
Device: skeletally anchored maxillary expander
used from day one and activated two times per day for two weeks
Other Names:
  • mini implant assisted rapid palatine expander
Active Comparator: skeletal expander with microosteoperforation in mid palatine and buccally
group2.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture and buccally
Device: skeletally anchored maxillary expander
used from day one and activated two times per day for two weeks
Other Names:
  • mini implant assisted rapid palatine expander

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skeletally transverse measurement
Time Frame: from start of treatment until study completion an average of 1 year
using cone beam computed tomography
from start of treatment until study completion an average of 1 year
dentolinear measurement
Time Frame: from start of treatment until study completion an average of 1 year
using cone beam computed tomography
from start of treatment until study completion an average of 1 year
dentoangular measurement
Time Frame: from start of treatment until study completion an average of 1 year
using cone beam computed tomography
from start of treatment until study completion an average of 1 year

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)

May 20, 2022

Primary Completion (Anticipated)

April 20, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 798/1901

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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