- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04968327
Micro-osteoperforations on the Rate of Canine Retraction
Effect of Micro-osteoperforations on the Rate of Canine Retraction; A Split-mouth Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt
- Alexandria Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Micro-osteoperforations
|
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
using nickel-titanium (NiTi) closed coil-springs delivering a force of 150 grams per side
|
|
Active Comparator: Canine retraction
|
using nickel-titanium (NiTi) closed coil-springs delivering a force of 150 grams per side
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of canine retraction
Time Frame: 12 weeks
|
measurements were recorded from digital dental models every 3 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurment of canine tipping
Time Frame: 12 weeks
|
Tipping of the maxillary canine during retraction was also evaluated from digital dental models
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Canine retraction2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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