Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction

Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction: Randomized Controlled Clinical Trial.

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.

Study Overview

• Status: Terminated
• Conditions: Canine Retraction; Orthodontic Treatment; Piezocorticision; Osteoperforation
• Intervention / Treatment: Procedure: Piezocorticision; Procedure: Osteoperforation

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3V1H9
      • clinique d'orthodontie de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; 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.
No Intervention: Control; The participants in this arm will receive no treatment, but will have the same monitoring as the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of canine retraction	The speed at which the canine is moved in the space of the extracted premolar.	From the time of force application until the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks. Measures will be taken at two week intervals.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of tipping	The angulation of the long axis of the canine at the end of the retraction.	The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Amount of root resorption	The total reduction in volume of the root of the canine caused by the canine retraction measured on the cone beam computed tomography.	The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Amount of posterior loss of anchorage	Measure of the amount of anterior movement of the posterior teeth during the retraction of the canine.	The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks
Concentration of IL-1 in the gingival fluid sample	Measure of the concentration of IL-I using the Luminex technique.	Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Concentration of receptor activator of nuclear factor kappa-B ligand (RANKL) in the gingival fluid sample	Measure of the concentration of RANKL using the Luminex technique.	Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Concentration of osteoprotegerin (OPG) in the gingival fluid sample	Measure of the concentration of OPG using the Luminex technique.	Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks.
Level of pain	Measure of the level of pain using a visual analogue scale of pain questionnaire ranging from 0-10.	Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures

Collaborators and Investigators

• Sponsor: Université de Montréal
• Collaborators: University of Michigan
• Investigators: Study Director: Clarice Nishio, D.M.D, MSc, PhD, Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Piezo and Osteoperforation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No