NCT04999150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

August 9, 2021

Last Update Submit

August 10, 2021

Conditions

Keywords

Corticotomy; MOP; Tooth movement

Outcome Measures

Primary Outcomes (1)

  • Canine retraction

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

    3 months

Study Arms (2)

Corticotomy

ACTIVE COMPARATOR

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

Micro-Osteoperforation

EXPERIMENTAL

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

Interventions

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)

Also known as: MOP
Micro-Osteoperforation
CorticotomyPROCEDURE

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)

Corticotomy

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Previous orthodontic or endodontic treatment of the canines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPR Medical Sciences Campus

San Juan, 00921, Puerto Rico

Location

Related Publications (13)

  • Li Y, Jacox LA, Little SH, Ko CC. Orthodontic tooth movement: The biology and clinical implications. Kaohsiung J Med Sci. 2018 Apr;34(4):207-214. doi: 10.1016/j.kjms.2018.01.007. Epub 2018 Feb 3.

    PMID: 29655409BACKGROUND
  • Aboul-Ela SM, El-Beialy AR, El-Sayed KM, Selim EM, El-Mangoury NH, Mostafa YA. Miniscrew implant-supported maxillary canine retraction with and without corticotomy-facilitated orthodontics. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):252-9. doi: 10.1016/j.ajodo.2009.04.028.

    PMID: 21300255BACKGROUND
  • Frost HM. The regional acceleratory phenomenon: a review. Henry Ford Hosp Med J. 1983;31(1):3-9. No abstract available.

    PMID: 6345475BACKGROUND
  • Verna C. Regional Acceleratory Phenomenon. Front Oral Biol. 2016;18:28-35. doi: 10.1159/000351897. Epub 2015 Nov 24.

    PMID: 26599115BACKGROUND
  • Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.

    PMID: 31155698BACKGROUND
  • Cheung T, Park J, Lee D, Kim C, Olson J, Javadi S, Lawson G, McCabe J, Moon W, Ting K, Hong C. Ability of mini-implant-facilitated micro-osteoperforations to accelerate tooth movement in rats. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):958-967. doi: 10.1016/j.ajodo.2016.04.030.

    PMID: 27894545BACKGROUND
  • Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. doi: 10.2319/0003-3219(2007)077[0417:OTAWCE]2.0.CO;2.

    PMID: 17465647BACKGROUND
  • Leethanakul C, Kanokkulchai S, Pongpanich S, Leepong N, Charoemratrote C. Interseptal bone reduction on the rate of maxillary canine retraction. Angle Orthod. 2014 Sep;84(5):839-45. doi: 10.2319/100613-737.1. Epub 2014 Mar 4.

    PMID: 24592904BACKGROUND
  • 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.

    PMID: 24182579BACKGROUND
  • 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.

    PMID: 13793201BACKGROUND
  • Arreghini A, Lombardo L, Mollica F, Siciliani G. Torque expression capacity of 0.018 and 0.022 bracket slots by changing archwire material and cross section. Prog Orthod. 2014 Sep 25;15(1):53. doi: 10.1186/s40510-014-0053-x.

    PMID: 25329505BACKGROUND
  • Pandis N, Walsh T, Polychronopoulou A, Katsaros C, Eliades T. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod. 2013 Dec;35(6):783-9. doi: 10.1093/ejo/cjs108. Epub 2013 Feb 1.

    PMID: 23376899BACKGROUND
  • Alikhani M, Alansari S, Sangsuwon C, et al. Micro-osteoperforations: Minimally invasive accelerated tooth movement. Semin Orthod. 2015; 21(3): 162-169.

    BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Augusto R Elias, DMD,MSD

    Assitant Dean of Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a split-mouth randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 10, 2021

Study Start

October 2, 2018

Primary Completion

July 11, 2019

Study Completion

September 26, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (B0710118)Access

Locations