Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage

September 12, 2022 updated by: Belal Abdelrahman Abdelmotaleb Elgohary, Al-Azhar University

Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage : A Prospective Clinical Study

Evaluation of effect of bracket slot system on the quality and quantity of tooth movement during leveling and alignment stage

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

  • Egypt
    • Cairo
      • Naşr, Cairo, Egypt, 44511
        • Alazhar 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

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • An age range from14 to18 years. All permanent teeth are erupted(3rd molar not included).
  • Angle class I malocclusion with normal facial proportions.
  • Moderate to severe crowding in the lower dental arch asassessed by lett irregularity Index that require treatment with fixed appliance using extraction approach.
  • There is no previous orthodontic treatment.

Exclusion Criteria:

  • Poor oral hygiene or periodontally compromised teeth.
  • Craniofacial anomalies or previous history of trauma, bruxism, or Parafunctions.
  • Uncooperativepatient.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bracket slot 0.018
Device: Bracket slot 0.018
That includes12 patients who will be treated using the bracket slot 0.018×0.025-inch system.
Active Comparator: Bracket slot 0.022
Device: Bracket slot 0.022
Includes12 patients who will be treated using the bracket slot 0.022×0.028-inch system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of tooth movement by different bracket slot system
Time Frame: At 8 months
Amount of tooth movement
At 8 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Alazhar University, 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 (Anticipated)

January 25, 2023

Primary Completion (Anticipated)

August 25, 2023

Study Completion (Anticipated)

October 25, 2023

Study Registration Dates

First Submitted

August 28, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 735/1246

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.

Subscribe