Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction

NCT03308851 | Terminated DMC

• 1 other identifier: Piezo and Osteoperforation
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Piezocorticision; Osteoperforation; Canine Retraction; Orthodontic Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Amount of tipping

  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 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

  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

  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

  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.

Study Arms (2)

Piezocorticision and osteoperforation group

EXPERIMENTAL

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; Procedure: Osteoperforation

Control

NO INTERVENTION

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

Interventions

Piezocorticision 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.

Piezocorticision and osteoperforation group

Osteoperforation 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.

Piezocorticision and osteoperforation group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Université de Montréal: lead
• University of Michigan: collaborator

Study Sites (1)

Clinique d'orthodontie de l'Université de Montréal

Montreal, Quebec, H3V1H9, Canada

Location

Study Officials

• Clarice Nishio, D.M.D, MSc, PhD

  Université de Montréal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 13, 2017
• Study Start: January 1, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

CA (1)