Healing After Endodontic Microsurgery Using a Rotary Bur Versus Piezoelectric Unit for Osteotomy and Root Resection
NCT ID: NCT07197658
Last Updated: 2025-09-29
Study Results
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Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2023-04-25
2026-12-10
Brief Summary
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The main questions it aims to answer are:
* Is there a difference in bone healing and reformation between the two surgical procedures ?
* Is there a difference in bone healing between cutting the bone with a rotary bur and cutting the bone with the 'bone window' technique that uses piezoelectric unit ?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
In the control group, piezoelectric surgery will be used for the same clinical procedures. All surgical procedures will be performed by one operator. Postsurgical healing as well as certain preoperative and postoperative parameters will be assessed and compared in the two groups. In a subgroup of patients having at least 2mm of intact buccal cortical bone thickness preoperatively, piezoelectric surgery will be used to prepare a rectangular buccal 'bone window'. The buccal bone thickness will be measured preoperatively on the coronal slices of the Cone Beam Computed Tomography (CBCT). After completing the root end filling, the bone window will be repositioned at the original position
BASIC_SCIENCE
SINGLE
Study Groups
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Group 1 (Experimental Group) - Rotary bur
Endodontic microsurgery will be performed by use of a rotary bur
endodontic microsurgery / rotary bur osteotomy
Endodontic microsurgery will be executed by use of a rotary bur
Group 2 (Control Group) - Piezoelectric unit
Endodontic microsurgery will be performed by use of a piezoelectric unit
Endodontic microsurgery / piezo osteotomy
Endodontic microsurgery will be performed by use of a piezosurgery unit
Bone Window subgroup
'Bone window' technique will be performed
Endodontic microsurgery / bone window
'Bone window' technique will be performed by use of piezoelectric surgery
Interventions
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endodontic microsurgery / rotary bur osteotomy
Endodontic microsurgery will be executed by use of a rotary bur
Endodontic microsurgery / piezo osteotomy
Endodontic microsurgery will be performed by use of a piezosurgery unit
Endodontic microsurgery / bone window
'Bone window' technique will be performed by use of piezoelectric surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Noncontributory medical history (American Society of Anesthesiologists class I and II)
* A history of previous endodontic treatment with radiographic presence of apical periodontitis
* A true endodontic lesion: microsurgical classification A, B, or C according to Kim and Kratchman, 2006.
* Lesion size 10 mm or smaller in diameter measured on preoperative CBCT
* Coronal restoration should be present at the time of follow up examination.
Exclusion Criteria
* Medical history with American Society of Anesthesiologists class III to V
* Insufficient coronal restoration
* Nonrestorability or traumatized teeth
* Teeth with microsurgical classification D, E, or F according to Kim and Kratchman, 2006.
* Mobility I or higher
* Radiographic presence of nonapical root resorption
* Teeth with a vertical root fracture or coronal/ midroot perforation
* Lesion size larger than 10 mm in diameter measured on preoperative CBCT
* Use of bone graft material for regeneration
18 Years
ALL
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Spyros Floratos
Principal Investigator
Principal Investigators
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Apostolos Tsolakis, DMD,MS,PhD
Role: STUDY_DIRECTOR
National Kapodistrian University of Athens
Locations
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Private Dental Office
Athens, Attica, Greece
Spyros Floratos Private Dental Office
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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References
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von Arx T, Janner SF, Hanni S, Bornstein MM. Agreement between 2D and 3D radiographic outcome assessment one year after periapical surgery. Int Endod J. 2016 Oct;49(10):915-25. doi: 10.1111/iej.12548. Epub 2015 Oct 8.
Chen I, Karabucak B, Wang C, Wang HG, Koyama E, Kohli MR, Nah HD, Kim S. Healing after root-end microsurgery by using mineral trioxide aggregate and a new calcium silicate-based bioceramic material as root-end filling materials in dogs. J Endod. 2015 Mar;41(3):389-99. doi: 10.1016/j.joen.2014.11.005. Epub 2015 Jan 14.
Hirsch V, Kohli MR, Kim S. Apicoectomy of maxillary anterior teeth through a piezoelectric bony-window osteotomy: two case reports introducing a new technique to preserve cortical bone. Restor Dent Endod. 2016 Nov;41(4):310-315. doi: 10.5395/rde.2016.41.4.310. Epub 2016 Jul 5.
Khoury F, Hensher R. The bony lid approach for the apical root resection of lower molars. Int J Oral Maxillofac Surg. 1987 Apr;16(2):166-70. doi: 10.1016/s0901-5027(87)80125-x.
Vercellotti T, De Paoli S, Nevins M. The piezoelectric bony window osteotomy and sinus membrane elevation: introduction of a new technique for simplification of the sinus augmentation procedure. Int J Periodontics Restorative Dent. 2001 Dec;21(6):561-7.
Yaman Z, Suer BT. Piezoelectric surgery in oral and maxillofacial surgery. Annals of Oral and Maxillofacial Surgery. 2013; 1:1-9
Chopra P, Chopra P. Piezosurgery and its applications in Periodontology and Implantology. International Journal of Contemporary Dentistry. 2011;2(4): 16-24
Rashad A, Kaiser A, Prochnow N, Schmitz I, Hoffmann E, Maurer P. Heat production during different ultrasonic and conventional osteotomy preparations for dental implants. Clin Oral Implants Res. 2011 Dec;22(12):1361-5. doi: 10.1111/j.1600-0501.2010.02126.x. Epub 2011 Mar 21.
Song M, Kim E. A prospective randomized controlled study of mineral trioxide aggregate and super ethoxy-benzoic acid as root-end filling materials in endodontic microsurgery. J Endod. 2012 Jul;38(7):875-9. doi: 10.1016/j.joen.2012.04.008. Epub 2012 May 16.
Tsesis I, Rosen E, Schwartz-Arad D, Fuss Z. Retrospective evaluation of surgical endodontic treatment: traditional versus modern technique. J Endod. 2006 May;32(5):412-6. doi: 10.1016/j.joen.2005.10.051.
Setzer FC, Shah SB, Kohli MR, Karabucak B, Kim S. Outcome of endodontic surgery: a meta-analysis of the literature--part 1: Comparison of traditional root-end surgery and endodontic microsurgery. J Endod. 2010 Nov;36(11):1757-65. doi: 10.1016/j.joen.2010.08.007. Epub 2010 Sep 17.
Safi C, Kohli MR, Kratchman SI, Setzer FC, Karabucak B. Outcome of Endodontic Microsurgery Using Mineral Trioxide Aggregate or Root Repair Material as Root-end Filling Material: A Randomized Controlled Trial with Cone-beam Computed Tomographic Evaluation. J Endod. 2019 Jul;45(7):831-839. doi: 10.1016/j.joen.2019.03.014. Epub 2019 May 9.
Floratos S, Kim S. Modern Endodontic Microsurgery Concepts: A Clinical Update. Dent Clin North Am. 2017 Jan;61(1):81-91. doi: 10.1016/j.cden.2016.08.007.
Kim S, Kratchman S. Modern endodontic surgery concepts and practice: a review. J Endod. 2006 Jul;32(7):601-23. doi: 10.1016/j.joen.2005.12.010. Epub 2006 May 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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129586
Identifier Type: -
Identifier Source: org_study_id
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