Assessment of Piezoelectric Periodontal Surgery Effects on Orthodontic Treatment: a Prospective Pilot Study
1 other identifier
interventional
14
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedOctober 26, 2017
October 1, 2017
10 months
February 4, 2015
October 24, 2017
Conditions
Keywords
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
EXPERIMENTALThe experimental group will consist of 14 adults, subjects from 18 to 40 years-old (10 women, 4 men).
conventional orthodontics
NO 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.
Interventions
Eligibility Criteria
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
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: 24564613BACKGROUNDDibart 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: 19715011BACKGROUNDDibart 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: 20814602BACKGROUNDDibart 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: 24253033BACKGROUNDKeser EI, Dibart S. Piezocision-assisted Invisalign treatment. Compend Contin Educ Dent. 2011 Mar;32(2):46-8, 50-1.
PMID: 21473299BACKGROUNDKeser 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: 24286911BACKGROUNDLong 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: 22720793BACKGROUNDMilano 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: 25006769BACKGROUNDMathews 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: 23810039BACKGROUNDSebaoun 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: 22105680BACKGROUNDStrippoli 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: 22717115BACKGROUNDVercellotti 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: 17726988BACKGROUNDYamaguchi 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julien Strippoli, DMD
University of Montreal, orthodontic department
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