Back to resultsMicro-osteoperforations on the Rate of Canine Retraction
Primary Purpose
Malocclusion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Micro-osteoperforations (MOPs)
Conventional canine retraction
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion
Eligibility Criteria
Inclusion Criteria:
- healthy systemic condition with no chronic diseases
- no previous orthodontic treatment
- adequate oral hygiene
- have a healthy periodontium
- signed an informed consent
Exclusion Criteria:
- have a chronic disease
- previous orthodontic treatment
- poor oral hygiene or periodontal conidition
Sites / Locations
- Alexandria Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Micro-osteoperforations
Canine retraction
Arm Description
Outcomes
Primary Outcome Measures
Rate of canine retraction
measurements were recorded from digital dental models every 3 weeks
Secondary Outcome Measures
Measurment of canine tipping
Tipping of the maxillary canine during retraction was also evaluated from digital dental models
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04968327
Brief Title
Micro-osteoperforations on the Rate of Canine Retraction
Official Title
Effect of Micro-osteoperforations on the Rate of Canine Retraction; A Split-mouth Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
August 18, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
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 study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction.
Detailed Description
Ten adult patients requiring maxillary first premolars' extraction were enrolled in this split-mouth randomized controlled clinical trial.
Micro-osteoperforations were randomly assigned to one side of the maxillary arch at the canine-premolar region, and the contralateral side served as the control.
Mini-screws were used for anchorage reinforcement, and canine retraction was performed using nickel-titanium closed coil springs, delivering a force of 150 grams per side.
The primary outcome was the measurement of canine retraction rate throughout the study period from digital dental models obtained every 3 weeks.
The secondary outcome was the detection of possible canine tipping during retraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split-mouth
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micro-osteoperforations
Arm Type
Experimental
Arm Title
Canine retraction
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Micro-osteoperforations (MOPs)
Intervention Description
MOPs included shallow perforations of the buccal cortical plate surrounding the tooth that requires orthodontic tooth movement, with no flap reflection was performed using a surgical bur using the special calibrated device called PROPEL
Intervention Type
Other
Intervention Name(s)
Conventional canine retraction
Intervention Description
using nickel-titanium (NiTi) closed coil-springs delivering a force of 150 grams per side
Primary Outcome Measure Information:
Title
Rate of canine retraction
Description
measurements were recorded from digital dental models every 3 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Measurment of canine tipping
Description
Tipping of the maxillary canine during retraction was also evaluated from digital dental models
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
healthy systemic condition with no chronic diseases
no previous orthodontic treatment
adequate oral hygiene
have a healthy periodontium
signed an informed consent
Exclusion Criteria:
have a chronic disease
previous orthodontic treatment
poor oral hygiene or periodontal conidition
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
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Micro-osteoperforations on the Rate of Canine Retraction
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