En Masse Distaliaztion Via Skeletal Anchorage

February 9, 2022 updated by: Ahmed Kadry Ahmed Algariah, Al-Azhar University

Evaluation of Two Bone Anchored Appliances for en Masse Distalization of Maxillary Buccal Segment in Class II Patients: A Comparative Clinical Study

Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.

Study Overview

Status

Recruiting

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
    • Nasr City
      • Cairo, Nasr City, Egypt
        • Recruiting
        • Al-Azhar University, faculty of dental medicine orthodontic clinic
        • Contact:

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 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full set of permanent teeth present, except for third molar
  • Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
  • No systemic conditions interfering with treatment, as reported by patient
  • No previous Orthodontic treatment
  • Good Oral Hygiene
  • No use of any for of anti-inflammatory drugs

Exclusion Criteria:

  • Patient who required surgery to correct skeletal discrepancies
  • Patient with congenital dentoskeletal disorders
  • Missed or Mutilated teeth in Maxillary arch
  • Patients with poor oral hygiene

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: Skeletally anchored Distal Jet appliance
Device: Distalization
Distalizing the posterior maxillary segment
Active Comparator: Skeletally anchored Hyrax screw distalizer
Device: Distalization
Distalizing the posterior maxillary segment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of distalization
Time Frame: 6 months
difference in initial and final position of maxillary posterior segment
6 months

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)

January 5, 2021

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dist007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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