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Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction

Primary Purpose

Malocclusion, Class I/II

Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Micro-Osteoperforations
Corticotomy
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Class I/II focused on measuring Corticotomy; MOP; Tooth movement

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UPR Medical Sciences Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Corticotomy

Micro-Osteoperforation

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 9, 2021
Last Updated
August 10, 2021
Sponsor
University of Puerto Rico
Collaborators
School of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04999150
Brief Title
Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction
Official Title
A Split-Mouth Randomized Clinical Trial for the Comparison of Corticotomy and Micro-Osteoperforations During Canine Retraction: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
September 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Puerto Rico
Collaborators
School of Dental Medicine

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Class I/II
Keywords
Corticotomy; MOP; Tooth movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a split-mouth randomized clinical trial.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticotomy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Micro-Osteoperforation
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Micro-Osteoperforations
Other Intervention Name(s)
MOP
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Corticotomy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Canine retraction
Description
Amount of tooth movement (in mm) attained by the maxillary canines after retracting them
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Augusto R Elias, DMD,MSD
Organizational Affiliation
Assitant Dean of Research
Official's Role
Study Director
Facility Information:
Facility Name
UPR Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29655409
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
Verna C. Regional Acceleratory Phenomenon. Front Oral Biol. 2016;18:28-35. doi: 10.1159/000351897. Epub 2015 Nov 24.
Results Reference
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PubMed Identifier
31155698
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
Results Reference
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PubMed Identifier
13793201
Citation
AMLER MH, JOHNSON PL, SALMAN I. Histological and histochemical investigation of human alveolar socket healing in undisturbed extraction wounds. J Am Dent Assoc. 1960 Jul;61:32-44. doi: 10.14219/jada.archive.1960.0152. No abstract available.
Results Reference
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Citation
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Citation
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Results Reference
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Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://irbrcm.rcm.upr.edu/
Available IPD/Information Identifier
B0710118

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Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction

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