Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction

NCT ID: NCT03308851

Last Updated: 2021-06-10

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

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-04-30

Brief Summary

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The primary objective of this research is to compare the rate of canine retraction following the osteoperforation and piezocorticision procedures in cases of first premolar extractions. The secondary objectives are to compare the second order movement of the canine (tipping), the amount of root resorption associated with the procedures, the inflammation process by measuring the inflammatory markers in the gingival crevicular fluid, the loss of posterior anchorage by measures on the cone beam computed tomography (CBCT) 3-dimensional radiograph and on the casts and to evaluate the pain level and the impact on quality of life following each procedure using the questionnaire of the visual analogue scale (VAS) of pain.

Detailed Description

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Conditions

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Piezocorticision Osteoperforation Canine Retraction Orthodontic Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A split mouth design will be used where the experimental subjects will receive one procedure on one side of the upper dental arch and another procedure on the other side.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Piezocorticision and osteoperforation group

All participants in this arm will receive the piezocorticision and osteoperforation procedures on the upper jaw on the left and the right side.

Group Type EXPERIMENTAL

Piezocorticision

Intervention Type PROCEDURE

The piezocorticision is a procedure that aims to accelerate the movement of teeth during an orthodontic treatment. It consists of a local anaesthesia followed by an incision of the buccal mucosa and an incision in the alveolar bone with a piezotome.

Osteoperforation

Intervention Type PROCEDURE

The osteoperforation is a procedure that aims to accelerate the movement of teeth during orthodontic treatment. It consists of a local anaesthesia followed by perforations of the buccal mucosa and alveolar bone using a specific osteoperforation tool.

Control

The participants in this arm will receive no treatment, but will have the same monitoring as the experimental group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Piezocorticision

The piezocorticision is a procedure that aims to accelerate the movement of teeth during an orthodontic treatment. It consists of a local anaesthesia followed by an incision of the buccal mucosa and an incision in the alveolar bone with a piezotome.

Intervention Type PROCEDURE

Osteoperforation

The osteoperforation is a procedure that aims to accelerate the movement of teeth during orthodontic treatment. It consists of a local anaesthesia followed by perforations of the buccal mucosa and alveolar bone using a specific osteoperforation tool.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Dental and/or skeletal Cl I and II requiring maxillary first premolar extraction.
* Young adults 16 years and older.
* Good overall health.
* Complete adult dentition.
* Cooperative.
* Acceptable hygiene.
* Absence of any periodontal disease (gingivitis, periodontitis).

Exclusion Criteria

* Non-cooperative, fearful patients or patients with intellectual disability.
* Patients requiring the regular use of nonsteroidal anti-inflammatory drugs (NSAID).
* Use of antibiotics in the last 6 months.
* Previous or current use of bisphosphonates, corticosteroids or immunosuppressive drugs.
* Smokers.
* Patients suffering from uncontrolled systemic diseases (ex. diabetes type I and II).
* Presence of oral or maxillofacial malformations (ex. cleft palate) or dental pathologies (ex. ankylosis, abscess).
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Le George Dinh-Khang

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clarice Nishio, D.M.D, MSc, PhD

Role: STUDY_DIRECTOR

Université de Montréal

Locations

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Clinique d'orthodontie de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Piezo and Osteoperforation

Identifier Type: -

Identifier Source: org_study_id

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