NCT02359760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

February 4, 2015

Last Update Submit

October 24, 2017

Conditions

Keywords

Rapid orthodonticsaccelerated orthodonticsPiezocisionflapless corticotomiesminimaly invasive

Outcome Measures

Primary Outcomes (1)

  • Determine the duration of orthodontic treatment associated with Piezocision

    Assessment of the length of orthodontic treatment following piezocision

    18 months

Secondary Outcomes (8)

  • Compare the duration of treatment with the control group

    18 months

  • Assess the overall quality of treatment (American Board of Orthodontics' grading system)

    18 months

  • Assessment of pain during treatment (numerical visual scale)

    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)

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

  • Evaluation of inflammatory markers (quantification of interleukin-1 (IL-1))

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

  • +3 more secondary outcomes

Study Arms (2)

Piezocision group

EXPERIMENTAL

The experimental group will consist of 14 adults, subjects from 18 to 40 years-old (10 women, 4 men).

Procedure: Piezocision

conventional orthodontics

NO INTERVENTION

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.

Interventions

PiezocisionPROCEDURE

Flapless corticotomies

Piezocision group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Montreal, orthodontic department

Montreal, Quebec, H3V 1H9, Canada

Location

Related Publications (13)

  • 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.

    PMID: 24564613BACKGROUND
  • 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.

    PMID: 19715011BACKGROUND
  • 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.

    PMID: 20814602BACKGROUND
  • 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.

    PMID: 24253033BACKGROUND
  • Keser EI, Dibart S. Piezocision-assisted Invisalign treatment. Compend Contin Educ Dent. 2011 Mar;32(2):46-8, 50-1.

    PMID: 21473299BACKGROUND
  • 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.

    PMID: 24286911BACKGROUND
  • 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.

    PMID: 22720793BACKGROUND
  • 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.

    PMID: 25006769BACKGROUND
  • 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.

    PMID: 23810039BACKGROUND
  • 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.

    PMID: 22105680BACKGROUND
  • 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.

    PMID: 22717115BACKGROUND
  • 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.

    PMID: 17726988BACKGROUND
  • 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.

    PMID: 19419454BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Julien Strippoli, DMD

    University of Montreal, orthodontic department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 10, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

April 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations