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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:
The aim of this study is to prospectively compare postsurgical healing after the use of microsurgical technique to eliminate apical pathology, either by use of rotary burs for osteotomy and root resection, or by use of piezoelectric surgery for the same clinical procedures. Null hypothesis is that there is no difference in healing and buccal bone thickness reformation between the two surgical procedures Another purpose of the study is to prospectively evaluate healing after the application of a novel buccal bone preservation technique, called the 'bone window' technique. The technique will be applied in a subgroup of patients on maxillary and mandibular premolar and molar teeth with an intact buccal cortical bone and healing and buccal bone reformation will be assessed at follow up. Null hypothesis in this part, is that there is no difference in healing and buccal bone preservation between osteotomy with a bur and the 'bone window' technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Experimental Group) - Rotary bur | Experimental | Endodontic microsurgery will be performed by use of a rotary bur |
|
| Group 2 (Control Group) - Piezoelectric unit | Active Comparator | Endodontic microsurgery will be performed by use of a piezoelectric unit |
|
| Bone Window subgroup | Active Comparator | 'Bone window' technique will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endodontic microsurgery / rotary bur osteotomy | Procedure | Endodontic microsurgery will be executed by use of a rotary bur |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Apostolos Tsolakis, DMD,MS,PhD | National and Kapodistrian University of Athens | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Dental Office | Athens | Attica | 11528 | Greece | ||
| Spyros Floratos Private Dental Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26356580 | Background | 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. | |
| 25596728 | 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. |
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Only IPD used in the results publication
Beginning 3 months and ending 3 years after the publication of results
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
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2025 |
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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
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|
| Endodontic microsurgery / piezo osteotomy | Procedure | Endodontic microsurgery will be performed by use of a piezosurgery unit |
|
|
| Endodontic microsurgery / bone window | Procedure | 'Bone window' technique will be performed by use of piezoelectric surgery |
|
|
| Athens |
| Attica |
| 11528 |
| Greece |
| 27847753 | 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. |
| 3110314 | 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. |
| 11794567 | 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. |
| 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 |
| 21435005 | 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. |
| 22703646 | 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. |
| 16631838 | 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. |
| 20951283 | 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. |
| 31078325 | 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. |
| 27912820 | 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. |
| 16793466 | 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. |
| Sep 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
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| ID | Term |
|---|---|
| D059745 | Piezosurgery |
| ID | Term |
|---|---|
| D059708 | Ultrasonic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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