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

Primary Purpose

Root Resorption

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
retraction method
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Root Resorption focused on measuring Two step retraction, En masse retraction, Cone Beam Computed Tomography

Eligibility Criteria

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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.

Sites / Locations

  • Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Two step retraction

En masse retraction

Arm Description

teeth will be retracted in two stages

teeth will be retracted in one stage

Outcomes

Primary Outcome Measures

Root resorption
Amount of root resorption in three dimensions

Secondary Outcome Measures

Full Information

First Posted
October 31, 2022
Last Updated
October 31, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05606185
Brief Title
Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure
Acronym
CBCT
Official Title
Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure Using Cone Beam Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Resorption
Keywords
Two step retraction, En masse retraction, Cone Beam Computed Tomography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two step retraction
Arm Type
Active Comparator
Arm Description
teeth will be retracted in two stages
Arm Title
En masse retraction
Arm Type
Experimental
Arm Description
teeth will be retracted in one stage
Intervention Type
Procedure
Intervention Name(s)
retraction method
Intervention Description
Three dimensional evaluation of root resorption using cone beam computed tomography
Primary Outcome Measure Information:
Title
Root resorption
Description
Amount of root resorption in three dimensions
Time Frame
8 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HIBA Tabassum, MDS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75530
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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