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Evaluation of Two Approaches of Micro-osteoperforations (MOPs) During Orthodontic Canine Retraction

Primary Purpose

Bimaxillary Protrusion, Angle Class II, Division 1, Dental Malocclusions

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
micro-osteoperforations
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bimaxillary Protrusion focused on measuring Micro-osteoperforation, Accelerated orthodontics, Tooth movement, Canine retraction

Eligibility Criteria

15 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:All patients should satisfy the following criteria:-

  1. Age range from 15-22 years.
  2. Malocclusion cases that require maxillary first premolars extractions followed by symmetrical canine retraction.
  3. All permanent teeth present, 3rd molars are excluded.
  4. Good oral and general health.
  5. No systemic disease/medication that could interfere with OTM.
  6. No previous orthodontic treatment.

Exclusion Criteria:

  1. Patient diagnosed to have an indication for non-extraction approach.
  2. Poor oral hygiene or periodontally compromised patient.
  3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
  4. Previous orthodontic treatment.

Sites / Locations

  • Al azhar university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control side

single Micro-osteoperforations side

Multiple Micro-osteoperforations side

Arm Description

Conventional side Canine retraction was commenced without micro-osteoperforations.

Three flapless micro-osteoperforations (MOPs) was performed for one time only distal to the maxillary canine before starting retraction.

Three flapless micro-osteoperforations (MOPs) was performed on repeated basis distal to the maxillary canine evey 28 days before canine retraction.

Outcomes

Primary Outcome Measures

Rate of canine retraction
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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2021
Last Updated
June 14, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04868721
Brief Title
Evaluation of Two Approaches of Micro-osteoperforations (MOPs) During Orthodontic Canine Retraction
Official Title
Evaluation of Two Approaches of Micro-osteoperforations During Orthodontic:A Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
June 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this clinical prospective study will be directed to evaluate two approaches of micro-osteoperforations (MOPs) during orthodontic canine retraction.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bimaxillary Protrusion, Angle Class II, Division 1, Dental Malocclusions
Keywords
Micro-osteoperforation, Accelerated orthodontics, Tooth movement, Canine retraction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control side
Arm Type
No Intervention
Arm Description
Conventional side Canine retraction was commenced without micro-osteoperforations.
Arm Title
single Micro-osteoperforations side
Arm Type
Experimental
Arm Description
Three flapless micro-osteoperforations (MOPs) was performed for one time only distal to the maxillary canine before starting retraction.
Arm Title
Multiple Micro-osteoperforations side
Arm Type
Experimental
Arm Description
Three flapless micro-osteoperforations (MOPs) was performed on repeated basis distal to the maxillary canine evey 28 days before canine retraction.
Intervention Type
Procedure
Intervention Name(s)
micro-osteoperforations
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 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.
Time Frame
change from start of canine retraction until 4 months .

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Al azhar university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Evaluation of Two Approaches of Micro-osteoperforations (MOPs) During Orthodontic Canine Retraction

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