- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04868721
Evaluation of Two Approaches of Micro-osteoperforations (MOPs) During Orthodontic Canine Retraction
Evaluation of Two Approaches of Micro-osteoperforations During Orthodontic:A Prospective Clinical Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The aim of the present clinical study was directed to evaluate the effectiveness of two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction.
This study was conducted on a total sample of 36 canines of 18 patients, 15-22 years old who required therapeutic extraction of maxillary 1st premolars and canine retraction. They were selected randomly from the Outpatient Clinic, Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.
they were randamly dived into two groups:as follows: Group I: include 9 patients , MOPs were performed for one time only on one side before retraction.
Group II: include 9 patients , MOPs were performed on repeated basis on one side.
Both maxillary canines, in each patient, were randomly assigned to either an experimental side or the control side in a simple split-mouth design. In the experimental side, micro-osteoperforations was performed distal to the maxillary canine at equal distance between maxillary canine and 2nd premolar before starting retraction, while the canines in the contralateral control side were retracted without micro-osteoperforations.
Extraction was done at the start of the treatment, and before fitting of the orthodontic appliance. Then upper dental arches were leveled and aligned using conventional sequences of wires.
Three flapless micro-osteoperforations was performed by using orthodontic miniscrews distal to the maxillary canines in the experimental side before starting retraction. Each perforation was 1.6 mm in diameter and 3-4 mm depth into the bone. Canines were completely retracted on 0.016 × 0.022 ̋ stainless steel wires by using closed coil spring delivered 150 gm force.
Patients were followed up every 28 days for 4 months of canine retraction. Routine orthodontic records were obtained for each patient before treatment.
Additionally, a full skull CBCT images were taken before treatment and immediately after canine retraction.
The rate of canine retraction was assessed clinically; in addition, cone beam CT (CBCT) scans were used to assess the amount of canine retraction root length changes. Also anchorage loss of first permanent molars were assessed.
The treatment results were compared clinically and radiographically (CBCT).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Al Azhar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:All patients should satisfy the following criteria:-
- Age range from 15-22 years.
- Malocclusion cases that require maxillary first premolars extractions followed by symmetrical canine retraction.
- All permanent teeth present, 3rd molars are excluded.
- Good oral and general health.
- No systemic disease/medication that could interfere with OTM.
- No previous orthodontic treatment.
Exclusion Criteria:
- Patient diagnosed to have an indication for non-extraction approach.
- Poor oral hygiene or periodontally compromised patient.
- Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
- Previous orthodontic treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: control side
Conventional side Canine retraction was commenced without micro-osteoperforations.
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Experimental: single Micro-osteoperforations side
Three flapless micro-osteoperforations (MOPs) was performed for one time only distal to the maxillary canine before starting retraction.
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three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.
Other Names:
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Experimental: Multiple Micro-osteoperforations side
Three flapless micro-osteoperforations (MOPs) was performed on repeated basis distal to the maxillary canine evey 28 days before canine retraction.
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three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of canine retraction
Time Frame: change from start of canine retraction until 4 months .
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clinically, patients were evaluated immediately before canine retraction and every 28days until for months. It was based on measuring the distance between the contact points on the distal surface of the canines and the contact points on mesial surface of the second premolars. |
change from start of canine retraction until 4 months .
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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
- 535/1147
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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