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Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance

Primary Purpose

Root Resorption

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Leveling and alignment
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Resorption

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy systemic condition/no systemic illness, as reported by patients.
  • No use any form of anti - inflammatory drugs the at beginning of study.
  • Good oral hygiene.
  • Cooperative and motivated.
  • In the permanent dentition with all teeth present ( except third molars).
  • Minimum to moderate anterior crowding.
  • No previous orthodontic treatment.

Exclusion Criteria:

  • Previous upper removable orthodontic treatment.
  • Patients who required surgery to correct skeletal discrepancies.
  • Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
  • Uncooperative patients.
  • Patients with poor oral hygiene.

Sites / Locations

  • AlAzhar Azhar UniversityRecruiting
  • Al Azhar university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

leveling and alignment using fixed orthodontic appliance

leveling and alignment using clear aligner

leveling and alignment using clear aligner with low level laser therapy

Arm Description

leveling and alignment using fixed orthodontic appliance

leveling and alignment using clear aligner

leveling and alignment using clear aligner with low level laser therapy

Outcomes

Primary Outcome Measures

Amount of Root resorption
Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software

Secondary Outcome Measures

Full Information

First Posted
December 18, 2021
Last Updated
January 9, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05232318
Brief Title
Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance
Official Title
Apical Root Resorption Accompanied Orthodontic Treatment Using Clear Aligners Versus Fixed Appliances: A CBCT Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

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

5. Study Description

Brief Summary
The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.
Detailed Description
by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
leveling and alignment using fixed orthodontic appliance
Arm Type
Active Comparator
Arm Description
leveling and alignment using fixed orthodontic appliance
Arm Title
leveling and alignment using clear aligner
Arm Type
Experimental
Arm Description
leveling and alignment using clear aligner
Arm Title
leveling and alignment using clear aligner with low level laser therapy
Arm Type
Experimental
Arm Description
leveling and alignment using clear aligner with low level laser therapy
Intervention Type
Other
Intervention Name(s)
Leveling and alignment
Intervention Description
Root resorption comparison through the use of CBCT
Primary Outcome Measure Information:
Title
Amount of Root resorption
Description
Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy systemic condition/no systemic illness, as reported by patients. No use any form of anti - inflammatory drugs the at beginning of study. Good oral hygiene. Cooperative and motivated. In the permanent dentition with all teeth present ( except third molars). Minimum to moderate anterior crowding. No previous orthodontic treatment. Exclusion Criteria: Previous upper removable orthodontic treatment. Patients who required surgery to correct skeletal discrepancies. Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate). Uncooperative patients. Patients with poor oral hygiene.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Obaida K Eldlemy
Phone
+201111488819
Email
ObaidaKhalil.209@azhar.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Obaida K Eldlemy
Phone
+201111488819
Email
obaida.khalil91@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Abouelnour, Lecturer
Organizational Affiliation
Lecturer, Department of Orthodontics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ramadan Y Aboushahba, Associate professor
Organizational Affiliation
Associate professor, Department of Orthodontics
Official's Role
Study Chair
Facility Information:
Facility Name
AlAzhar Azhar University
City
Cairo
State/Province
Or
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AlAzhar A University
Phone
+201001405584
Email
Dent.b.dean@azhar.edu.eg
Facility Name
Al Azhar university
City
Cairo
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AlAzhar University
Phone
+201001405584
Email
Dent.b.dean@azhar.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance

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