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Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction

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ClinicalTrials.gov Identifier: NCT03308851
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Le George Dinh-Khang, Université de Montréal

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.

Condition or disease Intervention/treatment Phase
Piezocorticision Osteoperforation Canine Retraction Orthodontic Treatment Procedure: Piezocorticision Procedure: Osteoperforation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction: Randomized Controlled Clinical Trial.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

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.



Primary Outcome Measures :
  1. Rate of canine retraction [ Time Frame: 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. ]
    The speed at which the canine is moved in the space of the extracted premolar.


Secondary Outcome Measures :
  1. Amount of tipping [ Time Frame: 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 ]
    The angulation of the long axis of the canine at the end of the retraction.

  2. Amount of root resorption [ Time Frame: 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 ]
    The total reduction in volume of the root of the canine caused by the canine retraction measured on the cone beam computed tomography.

  3. Amount of posterior loss of anchorage [ Time Frame: 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 ]
    Measure of the amount of anterior movement of the posterior teeth during the retraction of the canine.

  4. Concentration of IL-1 in the gingival fluid sample [ Time Frame: 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. ]
    Measure of the concentration of IL-I using the Luminex technique.

  5. Concentration of receptor activator of nuclear factor kappa-B ligand (RANKL) in the gingival fluid sample [ Time Frame: 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. ]
    Measure of the concentration of RANKL using the Luminex technique.

  6. Concentration of osteoprotegerin (OPG) in the gingival fluid sample [ Time Frame: 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. ]
    Measure of the concentration of OPG using the Luminex technique.

  7. Level of pain [ Time Frame: Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures ]
    Measure of the level of pain using a visual analogue scale of pain questionnaire ranging from 0-10.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308851


Contacts
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Contact: George Dinh-Khang Le, DMD (514) 343-6056 george.dinh-khang.le@umontreal.ca

Locations
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Canada, Quebec
Clinique d'orthodontie de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H3V1H9
Contact: Khang Le, DMD    438-275-2383    george.le@mail.mcgill.ca   
Sponsors and Collaborators
Université de Montréal
University of Michigan
Investigators
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Study Director: Clarice Nishio, D.M.D, MSc, PhD Université de Montréal
  Study Documents (Full-Text)

Documents provided by Le George Dinh-Khang, Université de Montréal:
Study Protocol  [PDF] October 5, 2017

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Responsible Party: Le George Dinh-Khang, Principal investigator, Université de Montréal
ClinicalTrials.gov Identifier: NCT03308851    
Other Study ID Numbers: Piezo and Osteoperforation
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No