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

June 4, 2026 updated by: Spyros Floratos, National and Kapodistrian University of Athens

Prospective Healing Assessment After Application of Endodontic Microsurgery for Elimination of Apical Pathology By Use of Either a Rotary Bur for Osteotomy and Apical Root Resection, or Piezoelectric Unit for the Same Clinical Procedures

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 ?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Spyros Floratos, DMD, PhDCand
  • Phone Number: +30 697 745 8959
  • Email: sflo_@hotmail.com

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11528
        • Private Dental Office
      • Athens, Attica, Greece, 11528
        • Spyros Floratos Private Dental Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 (Experimental Group) - Rotary bur
Endodontic microsurgery will be performed by use of a rotary bur
Procedure: endodontic microsurgery / rotary bur osteotomy
Endodontic microsurgery will be executed by use of a rotary bur
Other Names:
  • bur osteotomy
  • endodontic microsurgery
Active Comparator: Group 2 (Control Group) - Piezoelectric unit
Endodontic microsurgery will be performed by use of a piezoelectric unit
Procedure: Endodontic microsurgery / piezo osteotomy
Endodontic microsurgery will be performed by use of a piezosurgery unit
Other Names:
  • endodontic surgery
  • surgical endodontic retreatment
  • piezosurgery
Active Comparator: Bone Window subgroup
'Bone window' technique will be performed
Procedure: Endodontic microsurgery / bone window
'Bone window' technique will be performed by use of piezoelectric surgery
Other Names:
  • apical surgery
  • bone lid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Two dimensional radiographic bone healing
Time Frame: From execution of the microsurgical procedure to one year or later follow up examination
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
Time Frame: From execution of the microsurgical procedure to one year or later follow up examination
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National and Kapodistrian University of Athens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Apostolos Tsolakis, DMD,MS,PhD, National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 129586 (Integrated Reasearch Application System)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only IPD used in the results publication

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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