Dentoskeletal Changes Expansion Using Invisalign Versus Conventional Expander

June 11, 2023 updated by: Amr Samir Abdo Ibrahim, Al-Azhar University

Evaluation of Dentoskeletal Changes After Expansion Using Invisalign Versus Conventional Expander Prospective Clinical Study

Cbct evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Using cbct for evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander hyrax

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age (12-16)
  • Good oral hygiene
  • Constricted maxilla or moderate crowding

Exclusion Criteria:

  • Patient receive drugs
  • Periodontal diseas
  • Past Orthodontic treatment

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: Conventional expander
Expansion using conventional orthodontic expander(hyrax)
Device: Conventional expander
conventional expander
Experimental: Invisalign
Expansion with Invisalign appliance
Device: Invisalign
Expansion using Invisalign versus conventional expander
Other Names:
  • Hyrax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear amount of midpalatal Suture opening
Time Frame: 4 months
Apperance of Distema , calculate the amount of general space
4 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Study Director: Saleh A Saleh, Professor, Alazhar University
  • Study Director: Mohamad A Salem, Professor, Alazhar University
  • Study Director: Mohsena A Abdarrazik, Lecturer, Alazhar 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 (Estimated)

July 22, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AlazharU ASAIbrahim
  • S.A.Saleh (Registry Identifier: Saleh Anwar Saleh)
  • M.A.Salem (Registry Identifier: Mohamed Ahmad Salem)
  • M.A.Abdarrazik (Registry Identifier: Mohsena Ahmad Abdarrazik)

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.

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