Efficacy of inorganic bovine bone combined with leukocyte and platelet-rich fibrin or collagen membranes for treating unfavorable periodontal infrabony defects: Randomized non-inferiority trial.
bone transplantation
fibrin
randomized controlled trial
regeneration
wound healing
Journal
Journal of periodontology
ISSN: 1943-3670
Titre abrégé: J Periodontol
Pays: United States
ID NLM: 8000345
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
revised:
14
01
2021
received:
02
05
2020
accepted:
25
01
2021
pubmed:
7
2
2021
medline:
19
2
2022
entrez:
6
2
2021
Statut:
ppublish
Résumé
Growing evidence shows the efficacy of platelet concentrates in periodontal therapy. This study aimed to demonstrate that an inorganic bovine bone graft (IBB) in combination with a leukocyte and platelet rich fibrin (L-PRF) is non-inferior to a combination with a collagen membrane (CM) when managing unfavorable infrabony defects (IBDs). All patients exhibited at least one unfavorable IBD; they were randomly assigned to two groups, 31 treated with L-PRF+IBB and 31 with CM+IBB. A clinical and radiographic examination was performed at baseline and 12 months later. Clinical attachment level (CAL), gingival recession (GR), probing depth (PD), and radiographic defect bone level (DBL) post-therapy changes were compared between the two treatments. A non-inferiority margin = 1 mm was set to determine the efficacy of the test treatment (-1 mm for GR); a second non-inferiority margin = 0.5 mm (-0.5 mm for GR) was chosen for clinical relevance. Twelve months after surgery a significant improvement of clinical and radiographic parameters was observed at both experimental sites. The 90% confidence intervals of the CM+IBB-L-PRF+IBB mean difference for CAL gain (-0.810 mm [-1.300 to -0.319]) and DBL gain (-0.648 mm [-1.244 to -0.052]) were below the 0.5 mm non-inferiority margin; GR increase (1.284 mm [0.764 to 1.804]) remained above the -0.5 mm, while PD reduction (0.499 mm [0.145 to 0.853]) crossed its 0.5-mm margin. The L-PRF+IBB treatment of unfavorable IBDs offers non-inferior efficacy for CAL gain, showing less GR and more DBL gain too, while for PD reduction it is inferior to the CM+IBB treatment.
Sections du résumé
BACKGROUND
Growing evidence shows the efficacy of platelet concentrates in periodontal therapy. This study aimed to demonstrate that an inorganic bovine bone graft (IBB) in combination with a leukocyte and platelet rich fibrin (L-PRF) is non-inferior to a combination with a collagen membrane (CM) when managing unfavorable infrabony defects (IBDs).
METHODS
All patients exhibited at least one unfavorable IBD; they were randomly assigned to two groups, 31 treated with L-PRF+IBB and 31 with CM+IBB. A clinical and radiographic examination was performed at baseline and 12 months later. Clinical attachment level (CAL), gingival recession (GR), probing depth (PD), and radiographic defect bone level (DBL) post-therapy changes were compared between the two treatments. A non-inferiority margin = 1 mm was set to determine the efficacy of the test treatment (-1 mm for GR); a second non-inferiority margin = 0.5 mm (-0.5 mm for GR) was chosen for clinical relevance.
RESULTS
Twelve months after surgery a significant improvement of clinical and radiographic parameters was observed at both experimental sites. The 90% confidence intervals of the CM+IBB-L-PRF+IBB mean difference for CAL gain (-0.810 mm [-1.300 to -0.319]) and DBL gain (-0.648 mm [-1.244 to -0.052]) were below the 0.5 mm non-inferiority margin; GR increase (1.284 mm [0.764 to 1.804]) remained above the -0.5 mm, while PD reduction (0.499 mm [0.145 to 0.853]) crossed its 0.5-mm margin.
CONCLUSIONS
The L-PRF+IBB treatment of unfavorable IBDs offers non-inferior efficacy for CAL gain, showing less GR and more DBL gain too, while for PD reduction it is inferior to the CM+IBB treatment.
Identifiants
pubmed: 33547808
doi: 10.1002/JPER.20-0305
doi:
Substances chimiques
Collagen
9007-34-5
Types de publication
Equivalence Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1576-1587Informations de copyright
© 2021 American Academy of Periodontology.
Références
Papapanou P, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol. 2000;22:8-21.
Nieri M, Muzzi L, Cattabriga M, Rotundo R, Cairo F, Pini Prato GP. The prognostic value of several periodontal factors measured as radiographic bone level variation: a 10-year retrospective multilevel analysis of treated and maintained periodontal patients. J Periodontol. 2002;73:1485-1493.
Figueira EA, de Assis AO, Montenegro SCL, et al. Long-term periodontal tissue outcome in regenerated infrabony and furcation defects: a systematic review. Clin Oral Investig. 2014;18:1881-1892.
Gottlow J, Nyman S, Lindhe J, Karring T, Wennström J. New attachment formation in the human periodontium by guided tissue regeneration. Case reports. J Clin Periodontol. 1986;13:604-616.
Kao RT, Nares S, Reynolds MA. Periodontal regeneration-intrabony defects: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015;86:S77-S104.
Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human intrabony defects with bioresorbable membranes. A controlled clinical trial. J Periodontol. 1996;67:217-223.
Miron RJ, Zucchelli G, Pikos MA, et al. Use of platelet-rich fibrin in regenerative dentistry: a systematic review. Clin Oral Investig. 2017;21:1913-1927.
Paolantonio M. Combined periodontal regenerative technique in human intrabony defects by collagen membranes and anorganic bovine bone. A Controlled Clinical Study. J Periodontol. 2002;73:158-166.
Del Fabbro M, Karanxha L, Panda S, et al. Autologous platelet concentrates for treating periodontal infrabony defects. Cochrane Database Syst Rev. 2018;11:CD011423.
Stoecklin-Wasmer C, Rutjes AWS, da Costa BR, Salvi GE, Jüni P, Sculean A. Absorbable collagen membranes for periodontal regeneration: a systematic review. J Dent Res. 2013;92:773-781.
Sculean A, Nikolidakis D, Schwarz F. Regeneration of periodontal tissues: combinations of barrier membranes and grafting materials-biological foundation and preclinical evidence: a systematic review. J Clin Periodontol. 2008;35(8 Suppl):106-116.
Baldini N, De Sanctis M, Ferrari M. Deproteinized bovine bone in periodontal and implant surgery. Dent Mater. 2011;27:61-70.
Lekovic V, Milinkovic I, Aleksic Z, et al. Platelet-rich fibrin and bovine porous bone mineral vs. platelet-rich fibrin in the treatment of intrabony periodontal defects. J Periodontal Res. 2012;47:409-417.
Parrish LC, Miyamoto T, Fong N, Mattson JS, Cerutis DR. Non-bioabsorbable vs. bioabsorbable membrane: assessment of their clinical efficacy in guided tissue regeneration technique. A systematic review. J Oral Sci. 2009;51:383-400.
Graziani F, Gennai S, Cei S, et al. Clinical performance of access flap surgery in the treatment of the intrabony defect. A systematic review and meta-analysis of randomized clinical trials. J Clin Periodontol. 2012;39:145-156.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry, Non-Inferiority Clinical Trials, November 2016, Washington, DC.
Altman DG. Practical Statistics for Medical Research. London: Chapman & Hall; 1991:285.
Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004;23:1921-1986.
Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: framework and proposal of a new classification and case definition. J Periodontol. 2018;89(Suppl 1):S159-S172.
O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972;43:38.
Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975;25:229-235.
Tonetti MS, Pini-Prato G, Cortellini P. Periodontal regeneration of human intrabony defects. IV. Determinants of healing response. J Periodontol. 1993;64:934-940.
Choukroun J, Adda F, Schoeffer C, Vervelle A. PRF: an opportunity in perio-implantology. Implantodontie. 2000;42:55-62.
Cortellini P, Prato GP, Tonetti MS. The simplified papilla preservation flap. A novel surgical approach for the management of soft tissues in regenerative procedures. Int J Periodontics Restorative Dent. 1999;19:589-599.
Abu-Ta'a M. Adjunctive Systemic antimicrobial therapy vs asepsis in conjunction with guided tissue regeneration: a randomized, controlled clinical trial. J Contemp Dent Pract. 2016;17:3-6.
Huberty CJ, Morris D. Multivariate analysis versus multiple univariate analyses. Psychological bulletin. 1989;105:302-308.
Nyholt DR. A simple correction for multiple testing for single-nucleotide polymorphisms in linkage disequilibrium with each other. Am J Hum Genet. 2004;74:765-769.
Derringer J, A simple correction for non-independent tests. osf.io/re5w2. Published October 19, 2018. https://doi.org/10.17605/OSF.IO/F2TYW
The CONSORT Group. CONSORT. Available at http://www.consort-statement.org/. Accessed May 2, 2013.
Paolantonio M, Di Tullio M, Giraudi M, Romano L, Secondi L, Paolantonio G, Graziani F, Pilloni A, De Ninis P, Femminella B. Periodontal regeneration by leukocyte and platelet-rich fibrin with autogenous bone graft versus enamel matrix derivative with autogenous bone graft in the treatment of periodontal intrabony defects: A randomized non-inferiority trial. J Periodontol. 2020;91:1595-1608.
Bosshardt DD, Bornstein MM, Carrel J-P, Buser D, Bernard J-P. Maxillary sinus grafting with a synthetic, nanocrystalline hydroxyapatite-silica gel in humans: histologic and histomorphometric results. Int J Periodontics Restorative Dent. 2014;34:259-267.
Gassling V, Purcz N, Braesen J-H, et al. Comparison of two different absorbable membranes for the coverage of lateral osteotomy sites in maxillary sinus augmentation: a preliminary study. J Cranio-Maxillo-fac Surg Off Publ Eur Assoc Cranio-Maxillo-fac Surg. 2013;41:76-82.
Chandradas ND, Ravindra S, Rangaraju VM, Jain S, Dasappa S. Efficacy of platelet rich fibrin in the treatment of human intrabony defects with or without bone graft: a randomized controlled trial. J Int Soc Prev Community Dent. 2016;6(Suppl 2):S153-159.
Pradeep AR, Bajaj P, Rao NS, Agarwal E, Naik SB. Platelet-Rich fibrin combined with a porous hydroxyapatite graft for the treatment of 3-wall intrabony defects in chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2017;88:1288-1296.
Garrett S. Periodontal regeneration around natural teeth. Ann Periodontol. 1996;1:621-666.
Tsai CH, Shen SY, Zhao JH, Chang YC. Platelet-rich fibrin modulates cell proliferation of human periodontally related cells in vitro. J Dent Sci. 2009;4:130-135.
Arunachalam M, Pulikkotil SJ, Sonia N. Platelet rich fibrin in periodontal regeneration. Open Dent J. 2016;10:174-181.
Listgarten MA, Rosenberg MM. Histological study of repair following new attachment procedures in human periodontal lesions. J Periodontol. 1979;50:333-344.
Wikesjö UM, Nilvéus RE, Selvig KA. Significance of early healing events on periodontal repair: a review. J Periodontol. 1992;63:158-165.
S Medikeri R, Meharwade V, M Wate P, V Lele S. Effect of PRF and allograft use on immediate implants at extraction sockets with periapical infection -clinical and cone beam CT findings. Bull Tokyo Dent Coll. 2018;59:97-109.
Kawase T, Kamiya M, Kobayashi M, et al. The heat-compression technique for the conversion of platelet-rich fibrin preparation to a barrier membrane with a reduced rate of biodegradation. J Biomed Mater Res B Appl Biomater. 2015;103:825-831.
Wennström JL, Tomasi C, Bertelle A, Dellasega E. Full-mouth ultrasonic debridement versus quadrant scaling and root planing as an initial approach in the treatment of chronic periodontitis. J Clin Periodontol. 2005;32:851-859.
Ellegaard B, Löe H. New attachment of periodontal tissues after treatment of intrabony lesions. J Periodontol. 1971;42:648-652.
Trombelli L, Kim CK, Zimmerman GJ, Wikesjö UM. Retrospective analysis of factors related to clinical outcome of guided tissue regeneration procedures in intrabony defects. J Clin Periodontol. 1997;24:366-371.
Haney JM, Nilvéus RE, McMillan PJ, Wikesjö UM. Periodontal repair in dogs: expanded polytetrafluoroethylene barrier membranes support wound stabilization and enhance bone regeneration. J Periodontol. 1993;64:883-890.
Wikesjö UM, Nilvéus R. Periodontal repair in dogs: effect of wound stabilization on healing. J Periodontol. 1990;61:719-724.
Nevins ML, Camelo M, Lynch SE, Schenk RK, Nevins M. Evaluation of periodontal regeneration following grafting intrabony defects with bio-oss collagen: a human histologic report. Int J Periodontics Restorative Dent. 2003;23:9-17.
Qin D, Hua F, He H, Liang S, Worthington H, Walsh T. Quality of split-mouth trials in dentistry: 1998, 2008, and 2018. J Dent Res. 2020;3:22034520946025.
Chung B, Pandis N, Scherer RW, Elbourne D. CONSORT extension for within-person randomized clinical trials. J Dent Res. 2020;99:121-124.