Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction

Sponsor
University of Puerto Rico (Other)
Overall Status
Completed
CT.gov ID
NCT04999150
Collaborator
School of Dental Medicine (Other)
13
1
2
23.8
0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Micro-Osteoperforations
  • Procedure: Corticotomy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a split-mouth randomized clinical trial.a split-mouth randomized clinical trial.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Each patient was randomly assigned an identification number (S1-S13) by picking a sealed envelope. The randomization of IDs to the right or left side for MOP was accomplished with a 1:1 allocation ratio, using a computer-generated research randomizer.
Primary Purpose:
Treatment
Official Title:
A Split-Mouth Randomized Clinical Trial for the Comparison of Corticotomy and Micro-Osteoperforations During Canine Retraction: A Pilot Study
Actual Study Start Date :
Oct 2, 2018
Actual Primary Completion Date :
Jul 11, 2019
Actual Study Completion Date :
Sep 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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).

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

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).

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
  • Outcome Measures

    Primary Outcome Measures

    1. Canine retraction [3 months]

      Amount of tooth movement (in mm) attained by the maxillary canines after retracting them

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UPR Medical Sciences Campus San Juan Puerto Rico 00921

    Sponsors and Collaborators

    • University of Puerto Rico
    • School of Dental Medicine

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Puerto Rico
    ClinicalTrials.gov Identifier:
    NCT04999150
    Other Study ID Numbers:
    • UPR MSC IRB B0710118
    First Posted:
    Aug 10, 2021
    Last Update Posted:
    Aug 17, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by University of Puerto Rico
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2021