NCT03089996

Brief Summary

This study will compare the techniques of piezocision and alveolar corticotomies in accelerating orthodontic retraction movement of canines. In a second phase, this clinical trial will evaluate the effectiveness of micro-osteoperforations in accelerating the retraction of maxillary incisors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

5.2 years

First QC Date

January 31, 2017

Last Update Submit

December 14, 2022

Conditions

Orthodontic Tooth Movement

Keywords

piezocisioncorticotomyGingival Crevicular FluidMicro-osteperforations

Outcome Measures

Primary Outcomes (3)

  • Orthodontic Canine Retraction Rate

    The main objective is to evaluate and compare the canine retraction velocity in the different groups. Digital intra-oral scans will be performed (3Shape A / S®, Kopenhagen, Denmark) as registration method, every 14 days, up to 6 months.

    Up to 6 months

  • Anteroposterior displacement of the upper incisors

    The anteroposterior displacement of the upper incisors was assessed on superimposed digital models through the distance of points on the incisal edge and palatal cervical margin of these teeth to a coronal reference plan created on the initial CBCT scan.

    Up to 4 months

  • Space closure

    The space closure was assessed by the distance between the most menial point of the medial surface of the canine to the most distal point of the distal surface of the lateral incisor.

    Up to 4 months

Secondary Outcomes (6)

  • Duration of the effect of the surgical procedures

    Up to 6 months

  • Evaluation of biomarkers

    Up to 6 months

  • Patient Pain and discomfort

    Up to 6 months

  • First molars anchorage loss

    Up to 4 months

  • Changes of the inclination of the central incisors

    Up to 4 months

  • +1 more secondary outcomes

Study Arms (5)

Piezocision

EXPERIMENTAL

Piezocision-assisted canine retraction x Control (split mouth design)

Procedure: PiezocisionDevice: Control Side

Corticotomy

EXPERIMENTAL

Corticotomy-assisted canine retraction x Control (split mouth design)

Procedure: CorticotomyDevice: Control Side

Piezocision x Corticotomy

EXPERIMENTAL

Piezocision-assisted retraction x Corticotomy-assisted retraction (split mouth design)

Procedure: PiezocisionProcedure: Corticotomy

Micro-osteoperforations

EXPERIMENTAL

Micro-osteoperforations-assisted upper incisors retraction

Procedure: Micro-osteoperforations

Control

NO INTERVENTION

Upper incisors retraction not associated with any clinical intervention to accelerate tooth movement

Interventions

PiezocisionPROCEDURE

The first maxillary premolars will be extracted with orthodontic purpose. After 3 months of extraction, the orthodontic alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli®, Sorocaba, SP, Brazil). The retraction of the canines will begin using closed nickel-titanium spring (120g). The piezocision surgery will be performed only in one side of the mouth. Three vertical piezo-incisions will be performed near the edentulous region and mesially to the canine root, in the vestibular alveolar cortical bone with the Ultrasonic instrument (BS1 insert Piezotome ™, Satelec Group Acteon Merignac, France) in depth of 3 mm. The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months. The patients will be advised to take analgesics (paracetamol or dipyrone) only if necessary.

PiezocisionPiezocision x Corticotomy
CorticotomyPROCEDURE

The first maxillary premolars will be extracted with orthodontic purpose. After 3 months of extraction, the orthodontic alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli, Sorocaba, SP, Brazil).The retraction of the canines will begin using closed nickel-titanium spring (120g).The corticotomy surgery will be performed at the day of begining of canine retraction only in one side of the mouth.A mucoperiosteal flap will be raised from the extraction region to the mesial of the canine.Perforations will be performed using a number 2 spherical drill bit in low speed handpiece under irrigation, only in the cortical none depth.The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months.The patients will be advised to take analgesics (paracetamol or dipyrone) only if necessary.

CorticotomyPiezocision x Corticotomy
Control SideDEVICE

The first maxillary premolars will be extracted with orthodontic purpose. Fixed orthodontic appliance will be bonded (0.022x0.025 slot with MBT prescription in incisors and Standart in the other teeth) with a power arm welded in the bracks upper canines brackets. After 3 months of extraction, the alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli®, Sorocaba, SP, Brazil) between the roots of the second premolars and molars. At that time an intra-oral digital scan will be performed. The retraction of the canines will begin using closed nickel-titanium spring (120g of force) from the power arm to the mini-implant. No surgery will be done at this side. The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months.

CorticotomyPiezocision
Micro-osteoperforationsPROCEDURE

All micro-osteoperforations will be performed only once time in the experimental group on the same day of the installation of the upper incisors' retraction mechanics. Perforations will be performed with an individualized surgical guide and a 1.6 mm diameter stainless steel surgical drill perpendicular to the alveolar bone, 3 mm deep on the buccal surface, and 5 mm, on the palate. The depth of the perforations will be controlled and standardized by a cursor developed and patented by the research group. Two micro-osteoperforations will be aligned vertically distally from each upper incisor. Due to the proximity of the roots in the cervical third, only the most apical perforation will be performed between the two central incisors. The first perforation will be performed 6 mm away from the gingival margin, and the second, 5 mm from the first, in the vertical direction.

Also known as: MOP
Micro-osteoperforations

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient with orthodontic need for bilateral upper first premolar extraction.
  • Adequate dento-oral health
  • ASA I and ASA II
  • Compliance with clinic visits every 2 weeks

You may not qualify if:

  • History of periodontal disease
  • Smokers
  • Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
  • Pregnancy
  • Presence of cleft or any syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, 30535-610, Brazil

Location

Related Publications (3)

  • Mordente CM, Dores LS, Oliveira DD, Palomo JM, Souki BQ, Soares RV. Third Palatal Rugae as Stable Landmarks for Intraoral Models' Superimposition in Extraction Cases: A Retrospective Cohort Study. Orthod Craniofac Res. 2025 Dec 25. doi: 10.1111/ocr.70078. Online ahead of print.

    PMID: 41445469DERIVED

  • Mordente CM, Oliveira DD, Palomo JM, Cardoso PA, Assis MAL, Zenobio EG, Souki BQ, Soares RV. The effect of micro-osteoperforations on the rate of maxillary incisors' retraction in orthodontic space closure: a randomized controlled clinical trial. Prog Orthod. 2024 Feb 12;25(1):6. doi: 10.1186/s40510-023-00505-z.

    PMID: 38342823DERIVED

  • Fernandes LSDMCP, Figueiredo DSF, Oliveira DD, Houara RG, Rody WJ Jr, Gribel BF, Soares RV. The effects of corticotomy and piezocision in orthodontic canine retraction: a randomized controlled clinical trial. Prog Orthod. 2021 Oct 4;22(1):37. doi: 10.1186/s40510-021-00367-3.

    PMID: 34604918DERIVED

Study Officials

  • Rodrigo V Soares, Phd

    Pontifícia Universidade Católica de Minas Gerais

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 31, 2017

First Posted

March 24, 2017

Study Start

July 1, 2016

Primary Completion

September 16, 2021

Study Completion

September 16, 2021

Last Updated

December 28, 2022

Record last verified: 2022-12

Locations

BR(1)