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CompletedNCT04868721Updated Jun 16, 2022

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

An interventional study of micro-osteoperforations in Bimaxillary Protrusion, Angle Class II, Division 1 and Dental Malocclusions, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 15 Years to 22 Years. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2020, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
15 Years to 22 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

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

Keywords

  • Micro-osteoperforation
  • Accelerated orthodontics
  • Tooth movement
  • Canine retraction
03

In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 18 is below the median of 36 across 372 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 506 studies on the registry; 168 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • No intervention
    control side

    Conventional side Canine retraction was commenced without micro-osteoperforations.

  • Experimental
    single Micro-osteoperforations side

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

    Procedure: micro-osteoperforations

  • 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.

    Procedure: micro-osteoperforations

Interventions

  • Proceduremicro-osteoperforations

    three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.

    Also known as: MOPs

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: change from start of canine retraction until 4 months .

07

Study locations

1 site
  • Al azhar university
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04868721
Lead sponsor
Al-Azhar University
Responsible party
Bassem Atef Hassan Ahmed (Dentist, Ministry of Health-Egypt, Al-Azhar University) — Principal investigator
First posted
May 3, 2021
Start date
Nov 11, 2020
Primary completion
Feb 14, 2022
Completion
Jun 14, 2022
Last update
Jun 16, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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