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MalocclusionNCT02359760

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

A study testing Piezocision in people with Malocclusion, run by Université de Montréal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Malocclusion
What is being tested?
Piezocision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteCanada
Study dates
Mar 2015to Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Montreal, orthodontic department

    Montreal, Quebec, H3V 1H9

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Malocclusion
Being tested
Piezocision
Keywords
Rapid orthodontics, accelerated orthodontics, Piezocision, flapless corticotomies, minimaly invasive
Medical subject headings
Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PiezocisionProcedure or surgery

    Flapless corticotomies

Study groups in NCT02359760
Study groupRoleWhat they receive
Piezocision groupExperimentalThe experimental group will consist of 14 adults, subjects from 18 to 40 years-old (10 women, 4 men).
Receives: Procedure: Piezocision
conventional orthodonticsNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the duration of orthodontic treatment associated with Piezocision

    Assessment of the length of orthodontic treatment following piezocision

    Measured: 18 months

Secondary outcomes (8)

  1. 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.

    Measured: 18 months

  2. 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.

    Measured: 18 months

  3. Assessment of pain during treatment (numerical visual scale)

    Assessment of pain by Visual Digital Scale during treatment

    Measured: Every days after the surgery durin 7 days and one day after every appointment

  4. 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

    Measured: weeks 0, 1, 3, 5, 8, 12, 16, 24

  5. 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)

    Measured: weeks 0, 1, 3, 5, 8, 12, 16, 24

  6. 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)

    Measured: 18 months

  7. Evaluate root resorption with the Cone Beam Computerized Tomography (CBCT)

    Evaluation of root resorption using CBCT

    Measured: 18 months

  8. Evaluate the inflammatory and remodelling gene expression

    Evaluation of the gene expression associated with inflammation following piezocision

    Measured: 0 and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionJan 2016
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02359760
Sponsor's protocol ID
UMontreal
Status last verified
Oct 2017
First submitted
4 Feb 2015
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24564613

  • 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.

    PubMed 19715011

  • 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.

    PubMed 20814602

  • 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.

    PubMed 24253033

  • Keser EI, Dibart S. Piezocision-assisted Invisalign treatment. Compend Contin Educ Dent. 2011 Mar;32(2):46-8, 50-1.

    PubMed 21473299

  • 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.

    PubMed 24286911

  • 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.

    PubMed 22720793

  • 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.

    PubMed 25006769

  • 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.

    PubMed 23810039

  • 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.

    PubMed 22105680

  • 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.

    PubMed 22717115

  • 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.

    PubMed 17726988

  • 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.

    PubMed 19419454

Questions about this trial

What is this clinical trial studying?

A study testing Piezocision in people with Malocclusion, run by Université de Montréal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the duration of orthodontic treatment associated with Piezocision (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02359760, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.

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