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

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Piezocision
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Rapid orthodontics, accelerated orthodontics, Piezocision, flapless corticotomies, minimaly invasive

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Montreal, orthodontic department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Piezocision group

conventional orthodontics

Arm Description

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 with the same inclusion and exclusion criteria, who have been already treated by conventional orthodontics in the orthodontic clinic of the University of Montreal.

Outcomes

Primary Outcome Measures

Determine the duration of orthodontic treatment associated with Piezocision
Assessment of the length of orthodontic treatment following piezocision

Secondary Outcome Measures

Compare the duration of treatment with the control group
Compare the duration of treatment to the control group already processed and matched by sex, age, type of malocclusion, orthodontic biomechanics to limit bias.
Assess the overall quality of treatment (American Board of Orthodontics' grading system)
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.
Assessment of pain during treatment (numerical visual scale)
Assessment of pain by Visual Digital Scale during treatment
Evaluation of osteoclastic activity (analysis of RANKL and OPG markers by sampling in the gingival fluid with sterile paper points)
Osteoclastic activity measurement by analysis of RANKL and OPG markers by sampling in the gingival fluid with sterile paper points
Evaluation of inflammatory markers (quantification of interleukin-1 (IL-1))
Measurement of inflammatory markers in the gingival fluid with the quantification of interleukin-1 (IL-1)
Evaluate changes in density and bone volume with the cone beam computed tomography or Cone Beam Computerized Tomography (CBCT)
Evaluate changes in density and bone volume with the cone beam computed tomography or Cone Beam Computerized Tomography (CBCT)
Evaluate root resorption with the Cone Beam Computerized Tomography (CBCT)
Evaluation of root resorption using CBCT
Evaluate the inflammatory and remodelling gene expression
Evaluation of the gene expression associated with inflammation following piezocision

Full Information

First Posted
February 4, 2015
Last Updated
October 24, 2017
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02359760
Brief Title
Assessment of Piezoelectric Periodontal Surgery Effects on Orthodontic Treatment: a Prospective Pilot Study
Official Title
Assessment of Piezoelectric Periodontal Surgery Effects on Orthodontic Treatment: a Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Rapid orthodontics, accelerated orthodontics, Piezocision, flapless corticotomies, minimaly invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piezocision group
Arm Type
Experimental
Arm Description
The experimental group will consist of 14 adults, subjects from 18 to 40 years-old (10 women, 4 men).
Arm Title
conventional orthodontics
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Piezocision
Intervention Description
Flapless corticotomies
Primary Outcome Measure Information:
Title
Determine the duration of orthodontic treatment associated with Piezocision
Description
Assessment of the length of orthodontic treatment following piezocision
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Compare the duration of treatment with the control group
Description
Compare the duration of treatment to the control group already processed and matched by sex, age, type of malocclusion, orthodontic biomechanics to limit bias.
Time Frame
18 months
Title
Assess the overall quality of treatment (American Board of Orthodontics' grading system)
Description
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.
Time Frame
18 months
Title
Assessment of pain during treatment (numerical visual scale)
Description
Assessment of pain by Visual Digital Scale during treatment
Time Frame
Every days after the surgery durin 7 days and one day after every appointment
Title
Evaluation of osteoclastic activity (analysis of RANKL and OPG markers by sampling in the gingival fluid with sterile paper points)
Description
Osteoclastic activity measurement by 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
Title
Evaluation of inflammatory markers (quantification of interleukin-1 (IL-1))
Description
Measurement of inflammatory markers in the gingival fluid with the quantification of interleukin-1 (IL-1)
Time Frame
weeks 0, 1, 3, 5, 8, 12, 16, 24
Title
Evaluate changes in density and bone volume with the cone beam computed tomography or Cone Beam Computerized Tomography (CBCT)
Description
Evaluate changes in density and bone volume with the cone beam computed tomography or Cone Beam Computerized Tomography (CBCT)
Time Frame
18 months
Title
Evaluate root resorption with the Cone Beam Computerized Tomography (CBCT)
Description
Evaluation of root resorption using CBCT
Time Frame
18 months
Title
Evaluate the inflammatory and remodelling gene expression
Description
Evaluation of the gene expression associated with inflammation following piezocision
Time Frame
0 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Strippoli, DMD
Organizational Affiliation
University of Montreal, orthodontic department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Montreal, orthodontic department
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3V 1H9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24564613
Citation
Brugnami F, Caiazzo A, Dibart S. Lingual orthodontics: accelerated realignment of the "social six" with piezocision. Compend Contin Educ Dent. 2013 Sep;34(8):608-10.
Results Reference
background
PubMed Identifier
19715011
Citation
Dibart S, Sebaoun JD, Surmenian J. Piezocision: a minimally invasive, periodontally accelerated orthodontic tooth movement procedure. Compend Contin Educ Dent. 2009 Jul-Aug;30(6):342-4, 346, 348-50.
Results Reference
background
PubMed Identifier
20814602
Citation
Dibart S, Surmenian J, Sebaoun JD, Montesani L. Rapid treatment of Class II malocclusion with piezocision: two case reports. Int J Periodontics Restorative Dent. 2010 Oct;30(5):487-93.
Results Reference
background
PubMed Identifier
24253033
Citation
Dibart S, Yee C, Surmenian J, Sebaoun JD, Baloul S, Goguet-Surmenian E, Kantarci A. Tissue response during Piezocision-assisted tooth movement: a histological study in rats. Eur J Orthod. 2014 Aug;36(4):457-64. doi: 10.1093/ejo/cjt079. Epub 2013 Nov 19.
Results Reference
background
PubMed Identifier
21473299
Citation
Keser EI, Dibart S. Piezocision-assisted Invisalign treatment. Compend Contin Educ Dent. 2011 Mar;32(2):46-8, 50-1.
Results Reference
background
PubMed Identifier
24286911
Citation
Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.
Results Reference
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PubMed Identifier
22720793
Citation
Long H, Pyakurel U, Wang Y, Liao L, Zhou Y, Lai W. Interventions for accelerating orthodontic tooth movement: a systematic review. Angle Orthod. 2013 Jan;83(1):164-71. doi: 10.2319/031512-224.1. Epub 2012 Jun 21.
Results Reference
background
PubMed Identifier
25006769
Citation
Milano F, Dibart S, Montesani L, Guerra L. Computer-guided surgery using the piezocision technique. Int J Periodontics Restorative Dent. 2014 Jul-Aug;34(4):523-9. doi: 10.11607/prd.1741.
Results Reference
background
PubMed Identifier
23810039
Citation
Mathews DP, Kokich VG. Accelerating tooth movement: the case against corticotomy-induced orthodontics. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):5-13. doi: 10.1016/j.ajodo.2013.04.008. No abstract available.
Results Reference
background
PubMed Identifier
22105680
Citation
Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
Results Reference
background
PubMed Identifier
22717115
Citation
Strippoli J, Aknin JJ. [Accelerated tooth movement by alveolar corticotomy or piezocision]. Orthod Fr. 2012 Jun;83(2):155-64. doi: 10.1051/orthodfr/2012015. Epub 2012 Jun 21. French.
Results Reference
background
PubMed Identifier
17726988
Citation
Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.
Results Reference
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PubMed Identifier
19419454
Citation
Yamaguchi M. RANK/RANKL/OPG during orthodontic tooth movement. Orthod Craniofac Res. 2009 May;12(2):113-9. doi: 10.1111/j.1601-6343.2009.01444.x.
Results Reference
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Assessment of Piezoelectric Periodontal Surgery Effects on Orthodontic Treatment: a Prospective Pilot Study

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