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

NCT ID: NCT02359760

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-04-30

Brief Summary

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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

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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

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Malocclusion

Keywords

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Rapid orthodontics accelerated orthodontics Piezocision flapless corticotomies minimaly invasive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Piezocision group

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

Group Type EXPERIMENTAL

Piezocision

Intervention Type PROCEDURE

Flapless corticotomies

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Piezocision

Flapless corticotomies

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Clarice Nishio

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julien Strippoli, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Montreal, orthodontic department

Locations

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University of Montreal, orthodontic department

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 24564613 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19715011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20814602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24253033 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21473299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24286911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22720793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25006769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23810039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22105680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22717115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17726988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19419454 (View on PubMed)

Other Identifiers

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UMontreal

Identifier Type: -

Identifier Source: org_study_id