Back to resultsSingle Versus Repeated Piezocision-assisted Orthodontic Tooth Movement
Primary Purpose
Orthodontic Tooth Movement, Canine Retraction
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Single Piezocision
Repeated Piezocision
Sponsored by
About this trial
This is an interventional treatment trial for Orthodontic Tooth Movement
Eligibility Criteria
Inclusion Criteria: Malocclusion that requires at least the extraction of maxillary first premolars, such as Class I bimaxillary protrusion, and Class II division 1 cases. Normal shape and structure of the maxillary canines, with no history of root canal treatment Exclusion Criteria: Patients who underwent previous orthodontic treatment. Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
Sites / Locations
- Faculty of Dentistry, Alexandria UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single Piezocision
Repeated Piezocision
Arm Description
Outcomes
Primary Outcome Measures
Measurement of canine retraction
Several landmarks will be identified on the dental arch, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
Measurement of molar anchorage loss
Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.
Measurement of canine root resorption
Root resorption of the maxillary canines will be evaluated and measured by comparing pre-retraction and post-retraction CBCT scans.
Secondary Outcome Measures
Full Information
NCT ID
NCT05782088
First Posted
March 12, 2023
Last Updated
April 1, 2023
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT05782088
Brief Title
Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement
Official Title
Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria 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 primary aim of the study is to evaluate the effect of single and repeated piezocisions on the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both protocols on molar anchorage loss, as well as on canine root resorption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Tooth Movement, Canine Retraction
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
Single Piezocision
Arm Type
Experimental
Arm Title
Repeated Piezocision
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Single Piezocision
Intervention Description
Piezocision will be performed only once before the onset of canine retraction (T0) on one side of the maxillary arch that will be randomly chosen.
Intervention Type
Procedure
Intervention Name(s)
Repeated Piezocision
Intervention Description
Piezocision will be repeated three times, on a monthly basis (T0, T1, and T2), over the 12-week study period.
Primary Outcome Measure Information:
Title
Measurement of canine retraction
Description
Several landmarks will be identified on the dental arch, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
Time Frame
12 weeks
Title
Measurement of molar anchorage loss
Description
Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.
Time Frame
12 weeks
Title
Measurement of canine root resorption
Description
Root resorption of the maxillary canines will be evaluated and measured by comparing pre-retraction and post-retraction CBCT scans.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Malocclusion that requires at least the extraction of maxillary first premolars, such as Class I bimaxillary protrusion, and Class II division 1 cases.
Normal shape and structure of the maxillary canines, with no history of root canal treatment
Exclusion Criteria:
Patients who underwent previous orthodontic treatment.
Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farah Y Eid, PhD
Phone
01001495565
Ext
+2
Email
farahyousry66@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farah Y Eid, PhD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed R El-Kalza, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nourhan M Aly, BDS
Phone
(03) 4868308
Email
dent-dean@alexu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement
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