Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction

August 10, 2021 updated by: University of Puerto Rico

A Split-Mouth Randomized Clinical Trial for the Comparison of Corticotomy and Micro-Osteoperforations During Canine Retraction: A Pilot Study

Corticotomy and micro-osteoperforation (MOP) have been proven to accelerate tooth movement and shorten orthodontic treatment time, compared to conventional treatment. MOP is less invasive; however, it is unclear whether it is as effective as a corticotomy. The purpose of this study was to compare the maxillary canine retraction achieved by these techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirteen patients (5 females, 8 males; mean age, 18.07±6.74 years) with healthy permanent dentition requiring the extraction of maxillary first premolars were included in a split-mouth randomized clinical trial. Subjects with previous orthodontic or endodontic treatment of canines were excluded. At least 3 months post-extraction, MOPs, and corticotomies were performed distal to the canines. Mini-screws with closed-coil springs (150g) were used for canine retraction. Dental casts were attained at baseline (T0) and 3 months post-intervention (T1). Calibrated examiners measured the distances from the canine to the second premolar on both sides. A Signed-rank sum test was used to compare canine retraction achieved in 3 months (T0-T1) in two sides

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • UPR Medical Sciences Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy permanent dentition requiring the extraction of maxillary first premolars with less than 8mm of maxillary anterior crowding

Exclusion Criteria:

  • Previous orthodontic or endodontic treatment of the canines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corticotomy
  1. A full-thickness labial mucoperiosteal flap was reflected.
  2. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed . The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex until bone marrow was exposed.
  3. Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites.
  4. The mini-screws were placed.
  5. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g).
Procedure: Corticotomy

A full-thickness labial mucoperiosteal flap was reflected. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed. The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex, until bone marrow was exposed.

Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites.

The mini-screws were placed. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g)
Experimental: Micro-Osteoperforation
  1. MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA).
  2. Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced ~2mm apart) distal to the canine and perpendicular to the buccal cortical bone.
  3. The mini-screws were placed.
  4. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g).
Procedure: Micro-Osteoperforations

MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA).

Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced ~2mm apart) distal to the canine and perpendicular to the buccal cortical bone.

The mini-screws were placed. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g)

Other Names:
  • MOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canine retraction
Time Frame: 3 months
Amount of tooth movement (in mm) attained by the maxillary canines after retracting them
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Collaborators

School of Dental Medicine

Investigators

  • Study Director: Augusto R Elias, DMD,MSD, Assitant Dean of Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2018

Primary Completion (Actual)

July 11, 2019

Study Completion (Actual)

September 26, 2020

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPR MSC IRB B0710118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: B0710118

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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