Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction

NCT ID: NCT04999150

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-02

Study Completion Date

2020-09-26

Brief Summary

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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

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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

Conditions

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Malocclusion, Class I/II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a split-mouth randomized clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Corticotomy

Intervention Type PROCEDURE

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)

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).

Group Type EXPERIMENTAL

Micro-Osteoperforations

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

Other Intervention Names

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MOP

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zagreb

OTHER

Sponsor Role collaborator

University of Puerto Rico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Augusto R Elias, DMD,MSD

Role: STUDY_DIRECTOR

Assitant Dean of Research

Locations

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UPR Medical Sciences Campus

San Juan, , Puerto Rico

Site Status

Countries

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Puerto Rico

References

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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.

Reference Type BACKGROUND
PMID: 29655409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21300255 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 6345475 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26599115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31155698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27894545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17465647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24592904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24182579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13793201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25329505 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23376899 (View on PubMed)

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

Reference Type BACKGROUND

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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UPR MSC IRB B0710118

Identifier Type: -

Identifier Source: org_study_id

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