Endodontic Microsurgery

NCT06776289 | Not Yet Recruiting Phase 4

• 1 other identifier: 95694
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Apical Periodontitis

Keywords

endo; endodontic; microsurgery; apicoectomy; apico; prf; platelet rich fibrin

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months, 12 months, and 18 months

Secondary Outcomes (1)

• Healing outcome assessed using clinical and radiographic findings

  6 months, 12 months, and 18 months

Study Arms (2)

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.

Biological: Platelet rich fibrin

Microsurgery Alone

NO INTERVENTION

Endodontic microsurgery will be completed without PRF. The osteotomy will remain empty as per standard procedure.

Interventions

Platelet rich fibrin BIOLOGICAL

Platelet rich fibrin will be used to fill an osteotomy after endodontic microsurgery is completed.

Microsurgery with Platelet Rich Fibrin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mark Schachman: lead

Study Sites (1)

University of Kentucky College of Dentistry Endodontics Division

Lexington, Kentucky, 40508, United States

Location

Related Publications (11)

• 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.

  PMID: 33609186 BACKGROUND

• Fan 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.

  PMID: 32111269 BACKGROUND

• Mehta 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

• 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.

  PMID: 37182792 BACKGROUND

• Tsesis 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.

  PMID: 21763891 BACKGROUND

• Pinto 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.

  PMID: 32899437 BACKGROUND

• Torabinejad 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.

  PMID: 19567310 BACKGROUND

• Rud 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.

  PMID: 4199168 BACKGROUND

• Gorni 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.

  PMID: 14760899 BACKGROUND

• Maddalone 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.

  PMID: 12657145 BACKGROUND

• Setzer 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.

  PMID: 35670053 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Endometriosis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mark Schachman, DMD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Dawson, RDH, CCRC

CONTACT

8593235409; ddaws1@uky.edu

Michael Skanchy, DMD

CONTACT

859-562-2232; msk232@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Oral Radiologist assessing healing will not be aware if the patient had received PRF.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Program Director in Endodontics

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)