Flapless Mops for Acceleration of Canine Retraction
Primary Purpose
Dental Malocclusions, Angle Class II, Division 1, Bimaxillary Protrusion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Micro-osteoperforation
Sponsored by
About this trial
This is an interventional treatment trial for Dental Malocclusions focused on measuring MOPs, micro-osteoperforation, acceleration, orthodontic tooth movement
Eligibility Criteria
Inclusion Criteria:
- An age ranged between 14 to 18 years.
- Class II division 1 malocclusion or Class I bimaxillary protrusion with mild or no crowding. Wherever crowding was present, it was symmetrical on both sides of the arch.
- Patients who diagnosed to require extraction of at least maxillary first premolars bilaterally as a part of their treatment plan.
- Complete permanent dentition (3rdmolars were not included).
- Good oral and general health.
- No history of periodontal problems.
- No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances during the study period.
Exclusion Criteria:
- Blocked out or impacted maxillary canines.
- Transverse and/or vertical skeletal dysplasia or craniofacial anomalies.
- Systemic diseases or regular use of medications that could interfere with orthodontic treatment.
- Previous orthodontic treatment.
Sites / Locations
- Al azhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional side
Mops side
Arm Description
Canine retraction was commenced without micro-osteoperforations.
Canine retraction was commenced with micro-osteoperforations.
Outcomes
Primary Outcome Measures
Rate of canine retraction
Clinically, patients were evaluated immediately before canine retraction and every 4 weeks till complete space closure (complete canine retraction).
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.
Canine root length changes
The CBCT scans were taken before orthodontic treatment and after complete space closure (canine retraction) to be analyzed for assessment of Canine root length changes.
The root length was measured along the axis of the root, perpendicular to a line connecting the buccal and palatal cemento-enamel junction CEJ in sagittal view
Secondary Outcome Measures
Anchorage loss of maxillary first permanent molars.
mesial movement of maxillary first permanent molars bilaterally was measured before orthodontic treatment and after complete space closure ( canine retraction) on CBCT scan which were taken before orthodontic treatment and after complete canine retraction The distance measured along perpendicular from distal surface of 1st permanent molar to Ptv plane
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04383600
Brief Title
Flapless Mops for Acceleration of Canine Retraction
Official Title
Efficacy of Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
June 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Akram Elawady
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the present clinical study was directed to evaluate the effectiveness of micro-osteoperforations on the rate of canine retraction; in addition, the potential risk for root resorption during maxillary canine retraction.
Detailed Description
The aim of the present clinical study was directed to evaluate the effectiveness of micro-osteoperforations on the rate of canine retraction; in addition, the potential risk for root resorption during maxillary canine retraction.
This study was conducted on a total sample of 24 canines of 12 patients, 8 females and 4 males, with mean age was 16.17 ± 2.29 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.
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 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 until complete 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusions, Angle Class II, Division 1, Bimaxillary Protrusion
Keywords
MOPs, micro-osteoperforation, acceleration, orthodontic tooth movement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional side
Arm Type
No Intervention
Arm Description
Canine retraction was commenced without micro-osteoperforations.
Arm Title
Mops side
Arm Type
Experimental
Arm Description
Canine retraction was commenced with micro-osteoperforations.
Intervention Type
Procedure
Intervention Name(s)
Micro-osteoperforation
Other Intervention Name(s)
Mops
Intervention Description
three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.
Primary Outcome Measure Information:
Title
Rate of canine retraction
Description
Clinically, patients were evaluated immediately before canine retraction and every 4 weeks till complete space closure (complete canine retraction).
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.
Time Frame
change from start of canine retraction until complete space closure up to 6 months
Title
Canine root length changes
Description
The CBCT scans were taken before orthodontic treatment and after complete space closure (canine retraction) to be analyzed for assessment of Canine root length changes.
The root length was measured along the axis of the root, perpendicular to a line connecting the buccal and palatal cemento-enamel junction CEJ in sagittal view
Time Frame
change from start of orthodontic treatment until complete space closure up to 9 months
Secondary Outcome Measure Information:
Title
Anchorage loss of maxillary first permanent molars.
Description
mesial movement of maxillary first permanent molars bilaterally was measured before orthodontic treatment and after complete space closure ( canine retraction) on CBCT scan which were taken before orthodontic treatment and after complete canine retraction The distance measured along perpendicular from distal surface of 1st permanent molar to Ptv plane
Time Frame
change from start of orthodontic treatment until complete space closure up to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
An age ranged between 14 to 18 years.
Class II division 1 malocclusion or Class I bimaxillary protrusion with mild or no crowding. Wherever crowding was present, it was symmetrical on both sides of the arch.
Patients who diagnosed to require extraction of at least maxillary first premolars bilaterally as a part of their treatment plan.
Complete permanent dentition (3rdmolars were not included).
Good oral and general health.
No history of periodontal problems.
No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances during the study period.
Exclusion Criteria:
Blocked out or impacted maxillary canines.
Transverse and/or vertical skeletal dysplasia or craniofacial anomalies.
Systemic diseases or regular use of medications that could interfere with orthodontic treatment.
Previous orthodontic treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed El Awady
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al azhar university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Flapless Mops for Acceleration of Canine Retraction
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