Endodontic Microsurgery (EMS)

January 14, 2026 updated by: Mark Schachman

Endodontic Microsurgery With and Without Platelet-Rich Fibrin

Current literature on platelet rich fibrin (PRF) use in apicoectomies, also known as endodontic microsurgery, is sparse. PRF use in oral surgery or periodontal surgery has been more thoroughly researched. Whether it is able to reduce post-op pain or if it improves success rate in endodontic microsurgery is not well known. It is also not well known if it will be able to increase the rate of healing. This study will evaluate the success of endodontic microsurgery with and without PRF.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Periradicular surgery is an endodontic procedure comprising of surgical access to the periapical area to perform direct periradicular curettage, root-end resection, root-end preparation and filling. In situations where the outcome of primary root canal treatment is not sufficient, nonsurgical retreatment is considered the option of choice. Surgical endodontic treatment is usually employed to manage apical periodontitis when the orthograde approach (root canal treatment or retreatment) to the apical root anatomy (and infection) is irretrievably obstructed.

However, If the existing root canal anatomy cannot be successfully explored and instrumented with the radiographic presence of apical periodontitis, nonsurgical retreatment has been reported to be as low as low as 40%. In addition, a variety of tooth-related factors may necessitate surgical retreatment, including complicated root canal anatomy, the pathophysiology of the apical pathosis, extreme root curvatures, severe root canal alterations caused during treatment, non-removable root filling materials, existing posts at great risk for retreatment, and root fractures as well as perforations, resorptions, or root fractures. Furthermore, a surgical approach may be indicated when the periradicular tissues require direct visualization, debridement, excision, biopsy or management due to biomechanical failures.

Yan et al. found that the use of concentrated growth factors may influence the outcome of endodontic microsurgery. A systematic review by Mehta found that the use of platelet aggregates, such as PRF gave a favorable effect on the healing of apico-marginal defects, the research suggests that more studies are needed on the healing outcomes of endodontic microsurgery with PRF.

PRF has been widely used in regenerative dentistry, periodontics, and oral surgery with varying degrees of success. It is made through centrifugation of peripheral blood with the resulting centrifuged product is a solid fibrin clot sandwiched between the supernatant and blood cells. The matrix of the solid fibrin clot is a matrix consisting of platelets, leukocytes, a variety of growth factors, and cytokines as well as high biocompatibility due to its autologous source.

In this study patients will receive endodontic microsurgery with one group having the osteotomy filled with PRF prior to closure and another group having surgery completed without the use of PRF. Healing will be evaluated through a series of follow up exams, limited field of view cone beam computed tomography, and periapical radiographs. Additionally, patients will be asked to completed a visual analog scale post surgery for 7 days to track the patients pain response.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

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

  • Name: Dawn Dawson, RDH, CCRC
  • Phone Number: 8593235409
  • Email: ddaws1@uky.edu

Study Contact Backup

  • Name: Michael Skanchy, DMD
  • Phone Number: 859-562-2232
  • Email: msk232@uky.edu

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • University of Kentucky College of Dentistry Endodontics Division
        • Contact:
          • Dawn Dawson, RDH, CCRC
          • Phone Number: 8593235409
          • Email: ddaws1@uky.edu
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Maxillary or Mandibular Anterior teeth and premolars #4-13 and #20-29 with a history of failing RCT and a periapical radiolucency will be accepted

Exclusion Criteria:

  • Patients with vertical root fractures
  • Patients with non-restorable teeth
  • Patients with class 3 mobility
  • Pregnant
  • Smoker
  • Systematic disease contraindicating surgery

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microsurgery with Platelet Rich Fibrin
Patents will have a blood draw completed so that PRF can be made. Endodontic microsurgery will then be completed. Prior to closing the flap, PRF will be placed in the osteotomy.
Biological: Platelet rich fibrin
Platelet rich fibrin will be used to fill an osteotomy after endodontic microsurgery is completed.
No Intervention: Microsurgery Alone
Endodontic microsurgery will be completed without PRF. The osteotomy will remain empty as per standard procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone deposition using voxel-based imposition
Time Frame: 6 months, 12 months, and 18 months
From the CBCT images Invivo imaging software (Anatomage, San Jose, CA, USA) will be used to obtain measurements from voxel-based superimposition. The voxel-based imposition is automated by the software to match the voxel grayscale values from the two image volumes. Originally developed by Bazina et al. this analysis method has been demonstrated to show reliable and accurate data. The Linear measurements will be obtained on the cross-section view (sagittal, coronal, and axial) of the periapical lesion on CBCT-1 (6 months) and CBCT-2 (12 months) images.
6 months, 12 months, and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing outcome assessed using clinical and radiographic findings
Time Frame: 6 months, 12 months, and 18 months
Healing will be assessed by two, board-certified endodontists and a board-certified maxillofacial radiologist. If a consensus cannot be reached, an additional board-certified endodontist will assist in the determination. Healing assessment assisted with 2D imaging will be classified according to Friedmann. These will include healed, healing, or persistent disease. Each will be given a grade of 1-3, one being healed and 3 being persistent disease.
6 months, 12 months, and 18 months

Collaborators and Investigators

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

Sponsor

Mark Schachman

Investigators

  • Principal Investigator: Mark Schachman, DMD

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 (Estimated)

March 1, 2026

Primary Completion (Estimated)

July 28, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 95694

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At this time we are undecided if IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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