Apical PeriodontitisPhase 4EMSNCT06776289
Endodontic Microsurgery
A Phase 4 study testing Platelet rich fibrin in people with Apical Periodontitis, run by Mark Schachman at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Platelet rich fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with vertical root fractures
- Patients with non-restorable teeth
- Patients with class 3 mobility
- Pregnant
- Smoker
- Systematic disease contraindicating surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kentucky College of Dentistry Endodontics Division
Lexington, Kentucky, 40508
Mark Schachman, DMD, 8593238575, mark.schachman@uky.edu
Dawn Dawson, RDH, CCRC, 8593235409, ddaws1@uky.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Apical Periodontitis
- Being tested
- Platelet rich fibrin
- Keywords
- endo, endodontic, microsurgery, apicoectomy, apico, prf, platelet rich fibrin
- Medical subject headings
- Periapical Periodontitis, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinBiological
Platelet rich fibrin will be used to fill an osteotomy after endodontic microsurgery is completed.
| Study group | Role | What they receive |
|---|---|---|
| Microsurgery with Platelet Rich Fibrin | Experimental | 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. Receives: Biological: Platelet rich fibrin |
| Microsurgery Alone | No intervention | Endodontic microsurgery will be completed without PRF. The osteotomy will remain empty as per standard procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone deposition using voxel-based imposition
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.
Measured: 6 months, 12 months, and 18 months
Secondary outcomes (1)
Healing outcome assessed using clinical and radiographic findings
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.
Measured: 6 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be placed in group A or group B. Group A will have endodontic microsurgery without the use of PRF and group B will have endodontic microsurgery with the use of PRF.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Schachman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Schachman, University of Kentucky
- Investigators
- Mark Schachman, DMD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776289
- Sponsor's protocol ID
- 95694
- Acronym
- EMS
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time we are undecided if IPD will be shared.
Publications
Miron RJ, Moraschini V, Fujioka-Kobayashi M, Zhang Y, Kawase T, Cosgarea R, Jepsen S, Bishara M, Canullo L, Shirakata Y, Gruber R, Ferenc D, Calasans-Maia MD, Wang HL, Sculean A. Use of platelet-rich fibrin for the treatment of periodontal intrabony defects: a systematic review and meta-analysis. Clin Oral Investig. 2021 May;25(5):2461-2478. doi: 10.1007/s00784-021-03825-8. Epub 2021 Feb 20.
PubMed 33609186Fan Y, Perez K, Dym H. Clinical Uses of Platelet-Rich Fibrin in Oral and Maxillofacial Surgery. Dent Clin North Am. 2020 Apr;64(2):291-303. doi: 10.1016/j.cden.2019.12.012. Epub 2020 Feb 3.
PubMed 32111269Mehta N, Gupta A, Aggarwal V, Abraham D, Singh A. Effect of autologous platelet aggregates on the healing outcome of periapical surgery for the management of apicomarginal defects: A systematic review. Saudi Endodontic Journal. 2020 Sep 1;10(3):187- DOI:10.4103/sej.sej_146_19
Yan L, Lin J, Yang L, He S, Tan X, Huang D. Clinical Effect Evaluation of Concentrated Growth Factor in Endodontic Microsurgery: A Cross-Sectional Study. J Endod. 2023 Jul;49(7):836-845. doi: 10.1016/j.joen.2023.05.005. Epub 2023 May 12.
PubMed 37182792Tsesis I, Rosen E, Tamse A, Taschieri S, Del Fabbro M. Effect of guided tissue regeneration on the outcome of surgical endodontic treatment: a systematic review and meta-analysis. J Endod. 2011 Aug;37(8):1039-45. doi: 10.1016/j.joen.2011.05.016.
PubMed 21763891Pinto D, Marques A, Pereira JF, Palma PJ, Santos JM. Long-Term Prognosis of Endodontic Microsurgery-A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Sep 3;56(9):447. doi: 10.3390/medicina56090447.
PubMed 32899437Torabinejad M, Corr R, Handysides R, Shabahang S. Outcomes of nonsurgical retreatment and endodontic surgery: a systematic review. J Endod. 2009 Jul;35(7):930-7. doi: 10.1016/j.joen.2009.04.023.
PubMed 19567310Rud J, Andreasen JO, Jensen JE. Radiographic criteria for the assessment of healing after endodontic surgery. Int J Oral Surg. 1972;1(4):195-214. doi: 10.1016/s0300-9785(72)80013-9. No abstract available.
PubMed 4199168Gorni FG, Gagliani MM. The outcome of endodontic retreatment: a 2-yr follow-up. J Endod. 2004 Jan;30(1):1-4. doi: 10.1097/00004770-200401000-00001.
PubMed 14760899Maddalone M, Gagliani M. Periapical endodontic surgery: a 3-year follow-up study. Int Endod J. 2003 Mar;36(3):193-8. doi: 10.1046/j.1365-2591.2003.00642.x.
PubMed 12657145Setzer FC, Kratchman SI. Present status and future directions: Surgical endodontics. Int Endod J. 2022 Oct;55 Suppl 4:1020-1058. doi: 10.1111/iej.13783. Epub 2022 Jul 4.
PubMed 35670053
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodontic Microsurgery With and Without Platelet-Rich Fibrin
- ClinicalTrials.gov ID
- NCT06776289
- Acronym / sponsor ID
- EMS / 95694
- Conditions
- Apical Periodontitis
- Keywords
- endo, endodontic, microsurgery, apicoectomy, apico, prf, platelet rich fibrin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mark SchachmanUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be placed in group A or group B. Group A will have endodontic microsurgery without the use of PRF and group B will have endodontic microsurgery with the use of PRF.
| Arm | Type | Receives |
|---|---|---|
| Microsurgery with Platelet Rich Fibrin | Experimental | Biological: Platelet rich fibrinPatents 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. |
| Microsurgery Alone | No intervention | –Endodontic microsurgery will be completed without PRF. The osteotomy will remain empty as per standard procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with vertical root fractures
- Patients with non-restorable teeth
- Patients with class 3 mobility
- Pregnant
- Smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich fibrinPlatelet rich fibrin will be used to fill an osteotomy after endodontic microsurgery is completed. | Biological | Microsurgery with Platelet Rich Fibrin |
Primary outcome
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.
1 secondary outcome
Healing outcome assessed using clinical and radiographic findings
Time frame: 6 months, 12 months, and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 33609186Miron RJ, Moraschini V, Fujioka-Kobayashi M, Zhang Y, Kawase T, Cosgarea R, Jepsen S, Bishara M, Canullo L, Shirakata Y, Gruber R, Ferenc D, Calasans-Maia MD, Wang HL, Sculean A. Use of platelet-rich fibrin for the treatment of periodontal intrabony defects: a systematic review and meta-analysis. Clin Oral Investig. 2021 May;25(5):2461-2478. doi: 10.1007/s00784-021-03825-8. Epub 2021 Feb 20.
- Background: PubMed 32111269Fan Y, Perez K, Dym H. Clinical Uses of Platelet-Rich Fibrin in Oral and Maxillofacial Surgery. Dent Clin North Am. 2020 Apr;64(2):291-303. doi: 10.1016/j.cden.2019.12.012. Epub 2020 Feb 3.
- BackgroundMehta N, Gupta A, Aggarwal V, Abraham D, Singh A. Effect of autologous platelet aggregates on the healing outcome of periapical surgery for the management of apicomarginal defects: A systematic review. Saudi Endodontic Journal. 2020 Sep 1;10(3):187- DOI:10.4103/sej.sej_146_19
- Background: PubMed 37182792Yan L, Lin J, Yang L, He S, Tan X, Huang D. Clinical Effect Evaluation of Concentrated Growth Factor in Endodontic Microsurgery: A Cross-Sectional Study. J Endod. 2023 Jul;49(7):836-845. doi: 10.1016/j.joen.2023.05.005. Epub 2023 May 12.
- Background: PubMed 21763891Tsesis I, Rosen E, Tamse A, Taschieri S, Del Fabbro M. Effect of guided tissue regeneration on the outcome of surgical endodontic treatment: a systematic review and meta-analysis. J Endod. 2011 Aug;37(8):1039-45. doi: 10.1016/j.joen.2011.05.016.
- Background: PubMed 32899437Pinto D, Marques A, Pereira JF, Palma PJ, Santos JM. Long-Term Prognosis of Endodontic Microsurgery-A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Sep 3;56(9):447. doi: 10.3390/medicina56090447.
- Background: PubMed 19567310Torabinejad M, Corr R, Handysides R, Shabahang S. Outcomes of nonsurgical retreatment and endodontic surgery: a systematic review. J Endod. 2009 Jul;35(7):930-7. doi: 10.1016/j.joen.2009.04.023.
- Background: PubMed 4199168Rud J, Andreasen JO, Jensen JE. Radiographic criteria for the assessment of healing after endodontic surgery. Int J Oral Surg. 1972;1(4):195-214. doi: 10.1016/s0300-9785(72)80013-9. No abstract available.
- Background: PubMed 14760899Gorni FG, Gagliani MM. The outcome of endodontic retreatment: a 2-yr follow-up. J Endod. 2004 Jan;30(1):1-4. doi: 10.1097/00004770-200401000-00001.
- Background: PubMed 12657145Maddalone M, Gagliani M. Periapical endodontic surgery: a 3-year follow-up study. Int Endod J. 2003 Mar;36(3):193-8. doi: 10.1046/j.1365-2591.2003.00642.x.
- Background: PubMed 35670053Setzer FC, Kratchman SI. Present status and future directions: Surgical endodontics. Int Endod J. 2022 Oct;55 Suppl 4:1020-1058. doi: 10.1111/iej.13783. Epub 2022 Jul 4.
- Individual participant dataSharing planned: Undecided. At this time we are undecided if IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Schachman, DMD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet rich fibrin in people with Apical Periodontitis, run by Mark Schachman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawn Dawson, RDH, CCRC (8593235409, ddaws1@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone deposition using voxel-based imposition (time frame: 6 months, 12 months, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06776289, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.