Back to resultsRoot 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
About this trial
This is an interventional treatment trial for Root Resorption
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.
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
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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