A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance

May 21, 2024 updated by: Mohamed Abdelrhman Shendy Abdelrhman, Al-Azhar University

A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance Randomized Controlled Trial

this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

24

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

    • Nasr City
      • Cairo, Nasr City, Egypt, 002
        • Mohamed Shendy

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

14 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients suffering class I or II with AOB.
  • AOB ranged between 3-7 mm assessed from cephalometry.
  • Patients with excess in posterior dentoalveolar height according to Burrstone .
  • Patients with good oral hygiene and general health.
  • Patients with no previous orthodontic treatment.
  • Good quality of lateral cephalometry.

Exclusion Criteria:

  • Skeletal open bite
  • previous 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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Buccal miniscrews with TPA
active comparator double center
intrusion of molars
Active Comparator: vertical holding appliance
active comparator double center
intrusion of molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of dental
Time Frame: Post-intervention at 6 months
rate of maxillary molar intrusion by cephalometry
Post-intervention at 6 months
amount of skeletal changes
Time Frame: Post-intervention at 6 months
amount of vertical overlap by cephalometry
Post-intervention at 6 months
amount of skeletal changes
Time Frame: Post-intervention at 6 months
amount of mandibular rotation by cephalometry
Post-intervention at 6 months

Collaborators and Investigators

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

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)

April 10, 2022

Primary Completion (Estimated)

October 10, 2024

Study Completion (Estimated)

October 30, 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)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 807/220

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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