Healing After Endodontic Microsurgery Using a Rotary Bur Versus Piezoelectric Unit for Osteotomy and Root Resection

NCT07197658 | Recruiting

• 1 other identifier: 129586
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to compare bone healing after using apical tooth microsurgery to remove root end infection, either by use of rotary burs for cutting bone and root end, or by use of piezoelectric surgery for the same procedures. 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 ?

Conditions

Periapical Periodontitis; Endodontic Microsurgery; Osteotomy

Keywords

Endodontic surgery; Piezosurgery; Bone window

Outcome Measures

Primary Outcomes (2)

• Two dimensional radiographic bone healing

  Bone healing will be measured on periapical radiograph using well established two dimensional criteria for bone healing assessment. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing

  From execution of the microsurgical procedure to one year or later follow up examination

• Three dimensional radiographic bone healing

  Bone healing will be measured on Cone Beam Computed Tomography (CBCT) scan using well established three dimensional criteria for bone healing assessment. Penn 3D criteria categorize healing using CBCT scans into three categories: complete healing, limited and unsatisfactory healing

  From execution of the microsurgical procedure to one year or later follow up examination

Study Arms (3)

Group 1 (Experimental Group) - Rotary bur

EXPERIMENTAL

Endodontic microsurgery will be performed by use of a rotary bur

Procedure: endodontic microsurgery / rotary bur osteotomy

Group 2 (Control Group) - Piezoelectric unit

ACTIVE COMPARATOR

Endodontic microsurgery will be performed by use of a piezoelectric unit

Procedure: Endodontic microsurgery / piezo osteotomy

Bone Window subgroup

ACTIVE COMPARATOR

'Bone window' technique will be performed

Procedure: Endodontic microsurgery / bone window

Interventions

endodontic microsurgery / rotary bur osteotomy PROCEDURE

Endodontic microsurgery will be executed by use of a rotary bur

Also known as: bur osteotomy, endodontic microsurgery

Group 1 (Experimental Group) - Rotary bur

Endodontic microsurgery / piezo osteotomy PROCEDURE

Endodontic microsurgery will be performed by use of a piezosurgery unit

Also known as: endodontic surgery, surgical endodontic retreatment, piezosurgery

Group 2 (Control Group) - Piezoelectric unit

Endodontic microsurgery / bone window PROCEDURE

'Bone window' technique will be performed by use of piezoelectric surgery

Also known as: apical surgery, bone lid

Bone Window subgroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older consenting to the surgical procedure as well as agreeing to preoperative, postoperative and at least one follow-up CBCT evaluation after 12 months
• 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.

You may not qualify if:

• Nonconsenting patients and patients younger than 18 years of age
• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (2)

Private Dental Office

Athens, Attica, 11528, Greece

RECRUITING

Spyros Floratos Private Dental Office

Athens, Attica, 11528, Greece

RECRUITING

Related Publications (14)

• 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.

  PMID: 26356580 BACKGROUND

• 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.

  PMID: 25596728 BACKGROUND

• 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.

  PMID: 27847753 BACKGROUND

• 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.

  PMID: 3110314 BACKGROUND

• 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.

  PMID: 11794567 BACKGROUND

• Yaman Z, Suer BT. Piezoelectric surgery in oral and maxillofacial surgery. Annals of Oral and Maxillofacial Surgery. 2013; 1:1-9

  BACKGROUND

• Chopra P, Chopra P. Piezosurgery and its applications in Periodontology and Implantology. International Journal of Contemporary Dentistry. 2011;2(4): 16-24

  BACKGROUND

• 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.

  PMID: 21435005 BACKGROUND

• 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.

  PMID: 22703646 BACKGROUND

• 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.

  PMID: 16631838 BACKGROUND

• 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.

  PMID: 20951283 BACKGROUND

• 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.

  PMID: 31078325 BACKGROUND

• 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.

  PMID: 27912820 BACKGROUND

• 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.

  PMID: 16793466 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Piezosurgery

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Apostolos Tsolakis, DMD,MS,PhD

  National Kapodistrian University of Athens

  STUDY DIRECTOR

Central Study Contacts

Spyros Floratos, DMD, PhDCand

CONTACT

+30 697 745 8959; sflo_@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: For this prospective investigation, patients will be randomly allocated into two groups. In the experimental group, endodontic microsurgery will be performed by use of a rotary bur for osteotomy and apical root resection. 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

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 29, 2025
• Study Start: April 25, 2023
• Primary Completion: April 25, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: IPD will be shared with researchers outside the study team after their request. Request has to be made to the study's principal investigator with explanation of the reason / scientific purpose the IPD is requested. IPD will be offered for conducting meta-analysis, systematic review studies on pertinent research study topics to the study conducted. Raw data with pseudonyms and numbering of participants, protocol data, results data, statistical analysis will be offered. The principal investigator of the study maintain all raw data in numbered folders with no information that reveals the participant identity. Numbered folders with no personal information of participants, tables , statistical analysis, anonymized excel files will be sent by email to other researchers after they sign a confidentiality statement for use of the data

Locations

GR (2)