Clinical trial NCT06776289: Endodontic Microsurgery
Official title: Endodontic Microsurgery with and Without Platelet-Rich Fibrin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Apical Periodontitis
Keywords: endo
endodontic
microsurgery
apicoectomy
apico
prf
platelet rich fibrin
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in bone deposition using voxel-based imposition
timeFrame: 6 months, 12 months, and 18 months
Secondary outcomes:
measure: Healing outcome assessed using clinical and radiographic findings
timeFrame: 6 months, 12 months, and 18 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky College of Dentistry Endodontics Division
state: Kentucky
Study officials:
name: Mark Schachman, DMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.