Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure (CBCT)

October 31, 2022 updated by: Hiba Tabassum, Dow University of Health Sciences

Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure Using Cone Beam Computed Tomography

The goal of this study is to compare the three dimensional root resorption after extraction space closure in two groups: two step retraction and en masse retraction. Th main aim of this study is to conclude which method is less damaging to the roots.

Participants will be divided into two groups:

  1. En masse retraction (experimental)
  2. Two step retraction (control) Pre retraction and post retraction CBCT scans will be compared for both groups.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75530
        • Dow University of Health Sciences

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who signed the informed consent to be part of this study.
  • Patients with Class I or Class II malocclusion.
  • Patients requiring extractions of maxillary first premolars with absolute anchorage.
  • Good periodontal status.

Exclusion Criteria:

  • Patients who are syndromic or have cleft lip and/or palate.
  • Patients with severe root dilacerations or root canal treated incisors.
  • Patients receiving drugs that alter tooth movement.
  • Patients with systemic disease like endocrinological disorders, vit D excess or deficiency, thyroid or parathyroid problems.
  • Patients with history of trauma to dentition or impacted teeth in anterior maxilla.
  • Patients who have undergone 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Two step retraction
teeth will be retracted in two stages
Procedure: retraction method
Three dimensional evaluation of root resorption using cone beam computed tomography
Experimental: En masse retraction
teeth will be retracted in one stage
Procedure: retraction method
Three dimensional evaluation of root resorption using cone beam computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root resorption
Time Frame: 8 months
Amount of root resorption in three dimensions
8 months

Collaborators and Investigators

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

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: HIBA Tabassum, MDS, Dow University of Health Sciences

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)

December 9, 2019

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUHS/BASR/2019/-509

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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