Assessment of Piezoelectric Periodontal Surgery Effects on Orthodontic Treatment: a Prospective Pilot Study

October 24, 2017 updated by: Clarice Nishio, Université de Montréal
INTRODUCTION: Dentoalveolar surgeries such as piezocision, have been developed with the aim to accelerate the tooth movement and therefore reduce the length of orthodontic treatment. Although this surgical technique seems to present several advantages, such as decreased risk of decalcification or orthodontic relapse, its use as a routine practice is not yet recommended. The main purpose of this study is to determine the duration of orthodontic treatment by using the piezocision. The secondary objectives are to evaluate the effect of this surgical technique on bone density, root resorption, osteoclast activity, inflammatory events and pain assessment. MATERIAL AND METHODS: The investigators will conduct a prospective study. The experimental group will consist of 14 adults, subjects from 18 to 40 years-old (10 women, 4 men). The control group will consist of 30 matched patients, who have been already treated in the orthodontic clinic of the University of Montreal. The reliabilities of Intra and Inter assesors will be measured for each doctor. After completion of the surgical guides from CBCT, the Piezocision will be performed the same day of the bracket indirect placement. The surgical procedure will be standardized and did it by the same surgeon. The appointments will be every 2 weeks for 4 months, then every month. The investigators will make an assessment of pain by using a numerical visual scale, during the first 7 days after surgery. Analysis of inflammatory markers (IL-1) and osteoclast activity (RANKL, OPG) will be evaluated from the gingival sulcus fluid collected at day 0, 1, 3, 5, 8, 12, 16 and 24 weeks. At the end of the treatment, the overall quality evaluation of treatment using the "American Board of Orthodontics' grading system" would be realized by two blind external observers to limit bias.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

EXPECTED RESULTS Orthodontic treatment accelerated by piézocicison will be completed within one year and will be 50% faster than a traditional treatment. The ratio benefit / risk of performing the piezocision will be acceptable for the patient and the orthodontist. We expect the following results: low pain, and absence of dental and periodontal deleterious effect (no root resorption, no tooth vitality loss and no bone loss). The same cohort can be used in future studies to assess the long term stability of the treatment.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3V 1H9
        • University of Montreal, orthodontic department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • normal or low skeletal problem;
  • dental relationchip without extraction;
  • healthy;
  • complete adult teeth;
  • very cooperative;
  • no plaque;
  • no active periodontal disease and no bone loss visible radiographically;
  • patient wishing a shorter orthodontic treatment.

Exclusion Criteria:

  • patient regularly taking analgesic and antidepressants.
  • patients with alcool abuse problems.
  • patient smoking more than 10 cigarettes per day.
  • pregnant patient.
  • allergy to non-steroidal anti-inflammatory drugs.
  • local or systemic Immunodeficiencies.
  • uncontrolled systemic disease (For exaemple diabetes, cardiovascular disease).
  • coagulation problems or taking anti-coagulants.
  • presence of oral infections and periodontal disease uncontrolled active.
  • taking intravenous bisphosphonates or taking oral bisphosphonates for more than 4 years.
  • taking a long-term corticosteroids.
  • antibiotic necessary before any surgery and taking antibiotics within 6 months before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Piezocision group
The experimental group will consist of 14 adults, subjects from 18 to 40 years-old (10 women, 4 men).
Procedure: Piezocision
Flapless corticotomies
NO_INTERVENTION: conventional orthodontics
The control group will consist of 30 matched patients with the same inclusion and exclusion criteria, who have been already treated by conventional orthodontics in the orthodontic clinic of the University of Montreal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the duration of orthodontic treatment associated with Piezocision
Time Frame: 18 months
Assessment of the length of orthodontic treatment following piezocision
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the duration of treatment with the control group
Time Frame: 18 months
Compare the duration of treatment to the control group already processed and matched by sex, age, type of malocclusion, orthodontic biomechanics to limit bias.
18 months
Assess the overall quality of treatment (American Board of Orthodontics' grading system)
Time Frame: 18 months
At the end of the treatment, the overall quality evaluation of treatment using the "American Board of Orthodontics' grading system" would be realized by two blind external observers to limit bias.
18 months
Assessment of pain during treatment (numerical visual scale)
Time Frame: Every days after the surgery durin 7 days and one day after every appointment
Assessment of pain by Visual Digital Scale during treatment
Every days after the surgery durin 7 days and one day after every appointment
Evaluation of osteoclastic activity (analysis of RANKL and OPG markers by sampling in the gingival fluid with sterile paper points)
Time Frame: weeks 0, 1, 3, 5, 8, 12, 16, 24
Osteoclastic activity measurement by analysis of RANKL and OPG markers by sampling in the gingival fluid with sterile paper points
weeks 0, 1, 3, 5, 8, 12, 16, 24
Evaluation of inflammatory markers (quantification of interleukin-1 (IL-1))
Time Frame: weeks 0, 1, 3, 5, 8, 12, 16, 24
Measurement of inflammatory markers in the gingival fluid with the quantification of interleukin-1 (IL-1)
weeks 0, 1, 3, 5, 8, 12, 16, 24
Evaluate changes in density and bone volume with the cone beam computed tomography or Cone Beam Computerized Tomography (CBCT)
Time Frame: 18 months
Evaluate changes in density and bone volume with the cone beam computed tomography or Cone Beam Computerized Tomography (CBCT)
18 months
Evaluate root resorption with the Cone Beam Computerized Tomography (CBCT)
Time Frame: 18 months
Evaluation of root resorption using CBCT
18 months
Evaluate the inflammatory and remodelling gene expression
Time Frame: 0 and 8 weeks
Evaluation of the gene expression associated with inflammation following piezocision
0 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Investigators

  • Principal Investigator: Julien Strippoli, DMD, University of Montreal, orthodontic department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (ESTIMATE)

February 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMontreal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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