drugset / Trial / NCT05360511
Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects
RandomizedParallel-groupSingle-blindTreatment
Summary
The aim of the study is to evaluate the use of erythropoietin gel as an adjunct to xenograft in the surgical management of intrabony periodontal defects.
Timeline
- Start
- 2022-07-01
- Primary completion
- 2023-09-01
- Completion
- 2023-10-01
Publications
- Background Bollen CM, Mongardini C, Papaioannou W, Van Steenberghe D, Quirynen M. The effect of a one-stage full-mouth disinfection on different intra-oral niches. Clinical and microbiological observations. J Clin Periodontol. 1998 Jan;25(1):56-66. doi: 10.1111/j.1600-051x.1998.tb02364.x.
- Background Aslroosta H, Yaghobee S, Akbari S, Kanounisabet N. The effects of topical erythropoietin on non-surgical treatment of periodontitis: a preliminary study. BMC Oral Health. 2021 May 6;21(1):240. doi: 10.1186/s12903-021-01607-y.
- Background Cervellini I, Sacre S, Ghezzi P, Mengozzi M. Erythropoietin does not affect TNF and IL-6 production directly. J Biol Regul Homeost Agents. 2013 Jan-Mar;27(1):189-96.
- Background Csifo-Nagy BK, Solyom E, Bognar VL, Nevelits A, Dori F. Efficacy of a new-generation platelet-rich fibrin in the treatment of periodontal intrabony defects: a randomized clinical trial. BMC Oral Health. 2021 Nov 15;21(1):580. doi: 10.1186/s12903-021-01925-1.
- Background De Bruyckere T, Eghbali A, Younes F, Cleymaet R, Jacquet W, De Bruyn H, Cosyn J. A 5-year prospective study on regenerative periodontal therapy of infrabony defects using minimally invasive surgery and a collagen-enriched bovine-derived xenograft. Clin Oral Investig. 2018 Apr;22(3):1235-1242. doi: 10.1007/s00784-017-2208-x. Epub 2017 Sep 30.
- Background Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background Gemmell E, Marshall RI, Seymour GJ. Cytokines and prostaglandins in immune homeostasis and tissue destruction in periodontal disease. Periodontol 2000. 1997 Jun;14:112-43. doi: 10.1111/j.1600-0757.1997.tb00194.x. No abstract available.
- Background Hagi TT, Laugisch O, Ivanovic A, Sculean A. Regenerative periodontal therapy. Quintessence Int. 2014 Mar;45(3):185-92. doi: 10.3290/j.qi.a31203.
- Background Hamed S, Bennett CL, Demiot C, Ullmann Y, Teot L, Desmouliere A. Erythropoietin, a novel repurposed drug: an innovative treatment for wound healing in patients with diabetes mellitus. Wound Repair Regen. 2014 Jan-Feb;22(1):23-33. doi: 10.1111/wrr.12135. Epub 2013 Dec 13.
- Background Jayakumar A, Rajababu P, Rohini S, Butchibabu K, Naveen A, Reddy PK, Vidyasagar S, Satyanarayana D, Pavan Kumar S. Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with beta-tricalcium phosphate in human intra-osseous periodontal defects. J Clin Periodontol. 2011 Feb;38(2):163-72. doi: 10.1111/j.1600-051X.2010.01639.x. Epub 2010 Dec 6.
- Background Kantarci A, Van Dyke TE. Lipoxin signaling in neutrophils and their role in periodontal disease. Prostaglandins Leukot Essent Fatty Acids. 2005 Sep-Oct;73(3-4):289-99. doi: 10.1016/j.plefa.2005.05.019.
- Background Kou Y, Inaba H, Kato T, Tagashira M, Honma D, Kanda T, Ohtake Y, Amano A. Inflammatory responses of gingival epithelial cells stimulated with Porphyromonas gingivalis vesicles are inhibited by hop-associated polyphenols. J Periodontol. 2008 Jan;79(1):174-80. doi: 10.1902/jop.2008.070364.
- Background Matarasso M, Iorio-Siciliano V, Blasi A, Ramaglia L, Salvi GE, Sculean A. Enamel matrix derivative and bone grafts for periodontal regeneration of intrabony defects. A systematic review and meta-analysis. Clin Oral Investig. 2015 Sep;19(7):1581-93. doi: 10.1007/s00784-015-1491-7. Epub 2015 May 27.
- Background Page RC, Kornman KS. The pathogenesis of human periodontitis: an introduction. Periodontol 2000. 1997 Jun;14:9-11. doi: 10.1111/j.1600-0757.1997.tb00189.x. No abstract available.
- Background Papapanou PN, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol 2000. 2000 Feb;22:8-21. doi: 10.1034/j.1600-0757.2000.2220102.x. No abstract available.
- Background Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003 Dec;8(1):227-65. doi: 10.1902/annals.2003.8.1.227.
- Background Ryan ME. Nonsurgical approaches for the treatment of periodontal diseases. Dent Clin North Am. 2005 Jul;49(3):611-36, vii. doi: 10.1016/j.cden.2005.03.010.
- Background Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
- Background Siciliano VI, Andreuccetti G, Siciliano AI, Blasi A, Sculean A, Salvi GE. Clinical outcomes after treatment of non-contained intrabony defects with enamel matrix derivative or guided tissue regeneration: a 12-month randomized controlled clinical trial. J Periodontol. 2011 Jan;82(1):62-71. doi: 10.1902/jop.2010.100144. Epub 2010 Sep 1.
- Background Slots J, Ting M. Actinobacillus actinomycetemcomitans and Porphyromonas gingivalis in human periodontal disease: occurrence and treatment. Periodontol 2000. 1999 Jun;20:82-121. doi: 10.1111/j.1600-0757.1999.tb00159.x. No abstract available.
- Background Tonetti MS, Lang NP, Cortellini P, Suvan JE, Adriaens P, Dubravec D, Fonzar A, Fourmousis I, Mayfield L, Rossi R, Silvestri M, Tiedemann C, Topoll H, Vangsted T, Wallkamm B. Enamel matrix proteins in the regenerative therapy of deep intrabony defects. J Clin Periodontol. 2002 Apr;29(4):317-25. doi: 10.1034/j.1600-051x.2002.290407.x.
- Background Wang L, Wu F, Song Y, Duan Y, Jin Z. Erythropoietin induces the osteogenesis of periodontal mesenchymal stem cells from healthy and periodontitis sources via activation of the p38 MAPK pathway. Int J Mol Med. 2018 Feb;41(2):829-835. doi: 10.3892/ijmm.2017.3294. Epub 2017 Nov 28.
- Background Zheng DH, Wang XX, Ma D, Zhang LN, Qiao QF, Zhang J. Erythropoietin enhances osteogenic differentiation of human periodontal ligament stem cells via Wnt/beta-catenin signaling pathway. Drug Des Devel Ther. 2019 Jul 26;13:2543-2552. doi: 10.2147/DDDT.S214116. eCollection 2019.
- Results Mamajiwala AS, Sethi KS, Raut CP, Karde PA, Mamajiwala BS. Clinical and radiographic evaluation of 0.8% hyaluronic acid as an adjunct to open flap debridement in the treatment of periodontal intrabony defects: randomized controlled clinical trial. Clin Oral Investig. 2021 Sep;25(9):5257-5271. doi: 10.1007/s00784-021-03834-7. Epub 2021 Feb 17.
- Results Muhlemann HR, Son S. Gingival sulcus bleeding--a leading symptom in initial gingivitis. Helv Odontol Acta. 1971 Oct;15(2):107-13. No abstract available.
- Results Ramfjord SP. The Periodontal Disease Index (PDI). J Periodontol. 1967 Nov-Dec;38(6):Suppl:602-10. doi: 10.1902/jop.1967.38.6.602. No abstract available.
- Results Queiroz AC, Nobrega PB, Oliveira FS, Novaes AB Jr, Taba M Jr, Palioto DB, Grisi MF, Souza SL. Treatment of intrabony defects with anorganic bone matrix/p-15 or guided tissue regeneration in patients with aggressive periodontitis. Braz Dent J. 2013;24(3):204-12. doi: 10.1590/0103-6440201302169.
- Results SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
- Results Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | — | Topical |