Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics

May 26, 2023 updated by: Mahmoud Salah Mahmoud Ali Nassar, Al-Azhar University

Evaluation of Root Resorption Following Different Mandibular Incisors Intrusive Mechanics : A Randomized Clinical Trial

Evaluation of root resorption following different mandibular incisors intrusive mechanics : A randomized clinical trial

Study Overview

Study Type

Interventional

Enrollment (Estimated)

21

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

      • Cairo, Egypt
        • 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 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient will be included in this study if has:

    • An age range between 12 and 16 years.
    • Deep overbite with excessive curve of Spee of more than 5mm
    • Over erupted lower incisors.
    • Permanent teeth are all present (except for third molar).
    • No previous orthodontic treatment.
    • No indications or symptoms of periodontal disease in the past or present, as determined by clinical and radiographic examination

Exclusion Criteria:

  • Patients who needed surgery to fix skeletal problems.
  • Any previous trauma or root canal therapy
  • Missing lower incisor.
  • Patients with congenital dentoskeletal disorders

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: Mini-screw
7 patients will receive an intrusive force delivered by elastics from 2 mini-screws between mandibular lateral incisor and mandibular canine.
7 patients will receive an intrusive force delivered by elastics from 2 mini-screws between mandibular lateral incisor and mandibular canine.
Active Comparator: Utility arch
7 patients will receive an intrusive force delivered by intrusive utility arch.
7 patients will receive an intrusive force delivered by intrusive utility arch.
Active Comparator: Nitinol reverse curve wire
7 patients will receive an intrusive force delivered by Nitinol reverse curve wire.
7 patients will receive an intrusive force delivered by Nitinol reverse curve wire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear amount of root resorption
Time Frame: Change in Linear Root resorption at 6 months
Cone beam computed tomography linear measurements
Change in Linear Root resorption at 6 months
Volumetric amount of root resorption
Time Frame: Change in Volumetric Root resorption at 6 months
Cone beam computed tomography volumetric measurements
Change in Volumetric Root resorption at 6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Mahmoud S Nassar, student, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 15, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 29, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

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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