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Why is there a lack of evidence regarding errors and complications in periodontal and implant therapy?

dc.contributor.authorChambrone, Leandro
dc.contributor.authorZucchelli, Giovanni
dc.date.accessioned2023-09-06T00:46:35Z
dc.date.available2024-07-05 20:46:34en
dc.date.available2023-09-06T00:46:35Z
dc.date.issued2023-06
dc.identifier.citationChambrone, Leandro; Zucchelli, Giovanni (2023). "Why is there a lack of evidence regarding errors and complications in periodontal and implant therapy?." Periodontology 2000 (1): 13-20.
dc.identifier.issn0906-6713
dc.identifier.issn1600-0757
dc.identifier.urihttps://hdl.handle.net/2027.42/177614
dc.description.abstractThe occurrence of errors, complications, and adverse effects may occur as a consequence of single or multiple events related to the clinician and/or patient. Apparently, the amount of dental literature on these undesirable outcomes has not been as prolific as that obtained for conventional primary periodontal outcome measures. This review explores the potential reasons for the lack of studies reporting on errors and complications in periodontal and implant therapy, as well as other noteworthy methodological aspects, to enlighten their impact on the selection of the best (or most appropriate) “gold standard” periodontal/implant-related treatment options, and on the overall decision-making process. The following points were addressed: (a) the importance of reporting errors and complications in clinical research; (b) the adequate reporting of errors and complications in periodontology and dental implantology; and (c) efficacy trials vs effectiveness studies and their impact on the assessment and report of periodontal and implant treatment-related risks and complications.
dc.publisherAmerican Dental Association
dc.publisherWiley Periodicals, Inc.
dc.subject.otherimplant dentistry
dc.subject.otherperiodontology
dc.subject.othererrors
dc.subject.otheradverse effects
dc.titleWhy is there a lack of evidence regarding errors and complications in periodontal and implant therapy?
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelDentistry
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/177614/1/prd12445.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/177614/2/prd12445_am.pdf
dc.identifier.doi10.1111/prd.12445
dc.identifier.sourcePeriodontology 2000
dc.identifier.citedreferenceChambrone L, Wang HL, Romanos GE. Antimicrobial photodynamic therapy for the treatment of periodontitis and periimplantitis: an American Academy of periodontology best evidence review. J Periodontol. 2018; 89 ( 7 ): 783 - 803.
dc.identifier.citedreferenceLopez J, Juan I, Wu A, et al. The impact of financial conflicts of interest in plastic surgery: are they all created equal? Ann Plast Surg. 2016; 77 ( 2 ): 226 - 230.
dc.identifier.citedreferenceChambrone L, Pannuti CM, Tu YK, Chambrone LA. Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. J Periodontol. 2012; 83 ( 4 ): 477 - 490.
dc.identifier.citedreferenceBrignardello-Petersen R, Carrasco-Labra A, Yanine N, et al. Positive association between conflicts of interest and reporting of positive results in randomized clinical trials in dentistry. J Am Dent Assoc. 2013; 144 ( 10 ): 1165 - 1170.
dc.identifier.citedreferenceLandefeld CS, Steinman MA. The Neurontin legacy: marketing through misinformation and manipulation. N Engl J Med. 2009; 360 ( 2 ): 103 - 106.
dc.identifier.citedreferenceClementini M, Ambrosi A, Cicciarelli V, De Risi V, de Sanctis M. Clinical performance of minimally invasive periodontal surgery in the treatment of infrabony defects: systematic review and meta-analysis. J Clin Periodontol. 2019; 46 ( 12 ): 1236 - 1253.
dc.identifier.citedreferenceMatarasso 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; 19: 1581 - 1593.
dc.identifier.citedreferenceCairo F, Barbato L, Selvaggi F, Baielli MG, Piattelli A, Chambrone L. Surgical procedures for soft tissue augmentation at implant sites. A systematic review and meta-analysis of randomized controlled trials. Clin Implant Dent Relat Res. 2019; 21: 1262 - 1270.
dc.identifier.citedreferenceAvila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: a systematic review and meta-analysis. J Clin Periodontol. 2019; 46 ( Suppl 21 ): 195 - 223.
dc.identifier.citedreferenceNaenni N, Lim H, Papageorgiou SN, Hämmerle CHF. Efficacy of lateral bone augmentation prior to implant placement: a systematic review and meta-analysis. J Clin Periodontol. 2019; 46 ( Suppl. 21 ): 287 - 306.
dc.identifier.citedreferenceThoma DS, Bienz SP, Figuero E, Jung RE, Sanz-Martín I. Efficacy of lateral bone augmentation performed simultaneously with dental implant placement: a systematic review and meta-analysis. J Clin Periodontol. 2019; 46 ( Suppl. 21 ): 257 - 276.
dc.identifier.citedreferenceUrban IA, Montero E, Monje A, Sanz-Sánchez I. Effectiveness of vertical ridge augmentation interventions: a systematic review and meta-analysis. J Clin Periodontol. 2019; 46 ( Suppl. 21 ): 319 - 339.
dc.identifier.citedreferenceChan H-L, Lin G-H, Suarez F, MacEachern M, Wang H-L. Surgical management of peri-implantitis: a systematic review and meta-analysis of treatment outcomes. J Periodontol. 2014; 85 ( 8 ): 1027 - 1041.
dc.identifier.citedreferencePihlstrom BL, Curran AE, Voelker HT, Kingman A. Randomized controlled trials: what are they and who needs them? Periodontol 2000. 2012; 59 ( 1 ): 14 - 31.
dc.identifier.citedreferenceRamanauskaite A, Obreja K, Sader R, et al. Surgical treatment of periimplantitis with augmentative techniques. Implant Dent. 2019; 28 ( 2 ): 187 - 209.
dc.identifier.citedreferencePetrylak DP, Vogelzang NJ, Chatta K, et al. PSMA ADC monotherapy in patients with progressive metastatic castration-resistant prostate cancer following abiraterone and/or enzalutamide: efficacy and safety in open-label single-arm phase 2 study. Prostate. 2020; 80 ( 1 ): 99 - 108.
dc.identifier.citedreferenceMalka D, François E, Penault-Llorca F, et al. FOLFOX alone or combined with rilotumumab or panitumumab as first-line treatment for patients with advanced gastroesophageal adenocarcinoma (PRODIGE 17-ACCORD 20-MEGA): a randomised, open-label, three-arm phase II trial. Eur J Cancer. 2019; 115: 97 - 106.
dc.identifier.citedreferenceLiu E, Wang D, Sperling R, et al. Biomarker pattern of ARIA-E participants in phase 3 randomized clinical trials with bapineuzumab. Neurology. 2018; 90 ( 10 ): e877 - e886.
dc.identifier.citedreferenceAskar H, Di Gianfilippo R, Ravida A, Tattan M, Majzoub J, Wang H-L. Incidence and severity of postoperative complications following oral, periodontal and implant surgeries: a retrospective study. J Periodontol. 2019; 90 ( 11 ): 1270 - 1278.
dc.identifier.citedreferenceGriffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006; 77 ( 12 ): 2070 - 2079.
dc.identifier.citedreferenceHarris RJ, Miller R, Miller LH, Harris C. Complications with surgical procedures utilizing connective tissue grafts: a follow-up of 500 consecutively treated cases. Int J Periodontics Restorative Dent. 2005; 25 ( 5 ): 449 - 459.
dc.identifier.citedreferenceSakkas A, Konstantinidis I, Winter K, Schramm A, Wilde F. Effect of Schneiderian membrane perforation on sinus lift graft outcome using two different donor sites: a retrospective study of 105 maxillary sinus elevation procedures. GMS Interdiscip Plast Reconstr Surg DGPW. 2016; 5: Doc11.
dc.identifier.citedreferenceRosenthal R, Hoffmann H, Dwan K, Clavien PA, Bucher HC. Reporting of adverse events in surgical trials: critical appraisal of current practice. World J Surg. 2015; 39 ( 1 ): 80 - 87.
dc.identifier.citedreferenceSchulz KF, Altman DG, Moher D, CONSORT Group. CONSORT Statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010; 2010 ( 63 ): 834 - 840.
dc.identifier.citedreferencePage MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. J Clin Epidemiol. 2021; 134: 178 - 189.
dc.identifier.citedreferenceADA Clinical Practice Guidelines Handbook. American Dental Association. [Updated November 2013]. Accessed May 1, 2021. http://ebd.ada.org/contentdocs/ADA_Clinical_Practice_Guidelines_Handbook_-2013_Update.pdf.
dc.identifier.citedreferenceChambrone L. Evidence-Based Periodontal and Peri-Implant Plastic Surgery: A Clinical Roadmap from Function to Aesthetics. 1st ed. Springer International Publishing; 2015 323 p.
dc.identifier.citedreferenceChambrone L, Armitage GC. Commentary: statistical significance versus clinical relevance in periodontal research: implications for clinical practice. J Periodontol. 2016; 87 ( 6 ): 613 - 616.
dc.identifier.citedreferenceChambrone L, de Castro Pinto RCN, Chambrone LA. The concepts of evidence-based periodontal plastic surgery: application of the principles of evidence-based dentistry for the treatment of recession-type defects. Periodontol 2000. 2019; 79 ( 1 ): 81 - 106.
dc.identifier.citedreferenceZucchelli G, Wang H-L, Chambrone L. Complications and treatment errors in periodontal and implant therapy. Periodontol 2000. 2023; 92 ( 1 ): 9 - 12.
dc.identifier.citedreferenceTokede O, Walji M, Ramoni R, et al. Quantifying dental office-originating adverse events: the dental practice study methods. J Patient Saf. 2021; 17 ( 8 ): e1080 - e1087.
dc.identifier.citedreferenceWorld Health Organization. World Alliance for Patient Safety: WHO Draft Guidelines for Adverse Event Reporting and Learning Systems: From Information to Action. World Health Organization Press; 2005. https://apps.who.int/iris/handle/10665/69797.
dc.identifier.citedreferenceObadan EM, Ramoni RB, Kalenderian E. Lessons learned from dental patient safety case reports. J Am Dent Assoc. 2015; 146 ( 5 ): 318 - 326. e2.
dc.identifier.citedreferenceKalenderian E, Obadan-Udoh E, Maramaldi P, et al. Classifying adverse events in the dental office. J Patient Saf. 2021; 17 ( 6 ): e540 - e556.
dc.identifier.citedreferenceWilliams MR, McKeown A, Pressman Z, et al. Adverse event reporting in clinical trials of intravenous and invasive pain treatments: an ACTTION systematic review. J Pain. 2016; 17 ( 11 ): 1137 - 1149.
dc.identifier.citedreferenceMartin RCG, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg. 2002; 235 ( 6 ): 803 - 813.
dc.identifier.citedreferenceLee PE, Fischer HD, Rochon PA, et al. Published randomized controlled trials of drug therapy for dementia often lack complete data on harm. J Clin Epidemiol. 2008; 61 ( 11 ): 1152 - 1160.
dc.identifier.citedreferencePitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009; 169 ( 19 ): 1756 - 1761.
dc.identifier.citedreferencede Vries TW, van Roon EN. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials. Arch Dis Child. 2010; 95 ( 12 ): 1023 - 1026.
dc.identifier.citedreferenceSivendran S, Latif A, McBride RB, et al. Adverse event reporting in cancer clinical trial publications. J Clin Oncol. 2014; 32: 83 - 89.
dc.identifier.citedreferenceVaughan B, Goldstein MH, Alikakos M, Cohen LJ, Serby MJ. Frequency of reporting of adverse events in randomized controlled trials of psychotherapy vs. psychopharmacotherapy. Compr Psychiatry. 2014; 55 ( 4 ): 849 - 855.
dc.identifier.citedreferenceNuovo J, Sather C. Reporting adverse events in randomized controlled trials. Pharmacoepidemiol drug Saf. 2007; 16 ( 3 ): 349 - 351.
dc.identifier.citedreferenceParikh RP, Sharma K, Qureshi AA, Franco MJ, Myckatyn TM. Quality of surgical outcomes reporting in plastic surgery: a 15-year analysis of complication data. Plast Reconstr Surg. 2018; 141 ( 6 ): 1332 - 1340.
dc.identifier.citedreferenceMorzycki AD, Hudson AS, Samargandi OA, Bezuhly M, Williams JG. Reporting adverse events in plastic surgery: a systematic review of randomized controlled trials. Plast Reconstr Surg. 2019; 143 ( 1 ): 199e - 208e.
dc.identifier.citedreferenceIoannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med. 2009; 169 ( 19 ): 1737 - 1739.
dc.identifier.citedreferenceHodkinson A, Gamble C, Smith CT. Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. Trials. 2016; 17 ( 1 ): 207.
dc.identifier.citedreferenceJüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and Rofecoxib: cumulative meta-analysis. Lancet. 2004; 364 ( 9450 ): 2021 - 2029.
dc.identifier.citedreferenceChambrone L, Ramos UD, Reynolds MA. Infrared lasers for the treatment of moderate to severe periodontitis: an American Academy of Periodontology best evidence review. J Periodontol. 2018; 89 ( 7 ): 743 - 765.
dc.identifier.citedreferenceMcGuire MK, Scheyer ET, Gwaltney C. Commentary: incorporating patient-reported outcomes in periodontal clinical trials. J Periodontol. 2014; 85 ( 10 ): 1313 - 1319.
dc.identifier.citedreferenceBotelho J, Machado V, Proença L, et al. The impact of nonsurgical periodontal treatment on oral health-related quality of life: a systematic review and meta-analysis. Clin Oral Investig. 2020; 24 ( 2 ): 585 - 596.
dc.identifier.citedreferenceCimprich B, Paterson AG. Health-related quality of life: conceptual issues and research applications. In: Inglehart MR, Bagramian RA, eds. Oral Health-Related Quality of Life. Quintessence; 2002: 47 - 54.
dc.identifier.citedreferenceDierens M, Collaert B, Deschepper E, Browaeys H, Klinge B, De Bruyn H. Patient-centered outcome of immediately loaded implants in the rehabilitation of fully edentulous jaws. Clin Oral Implants Res. 2009; 20 ( 10 ): 1070 - 1077.
dc.identifier.citedreferenceChambrone L, Sukekava F, Araújo MG, Pustiglioni FE, Chambrone LA, Lima LA. Root coverage procedures for the treatment of localised recession-type defects. Cochrane Database Syst Rev. 2009;( 2 ): CD007161.
dc.identifier.citedreferenceZucchelli G, Mele M, Stefanini M, et al. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010; 37 ( 8 ): 728 - 738.
dc.identifier.citedreferenceFardal Ø, McCulloch CA. Impact of anxiety on pain perception associated with periodontal and implant surgery in a private practice. J Periodontol. 2012; 83 ( 9 ): 1079 - 1085.
dc.identifier.citedreferenceMcGrath C, Lam O, Lang N. An evidence-based review of patient-reported outcome measures in dental implant research among dentate subjects. J Clin Periodontol. 2012; 39 ( Suppl. 12 ): 193 - 201.
dc.identifier.citedreferenceInglehart MR. Enhancing periodontal health through regenerative approaches: a commentary on the need for patient-reported outcomes. J Periodontol. 2015; 86 ( Suppl ): S4 - S7.
dc.identifier.citedreferenceChambrone L, Salinas Ortega MA, Sukekava F, et al. Root coverage procedures for treating localised andmultiple recession-type defects. Cochrane Database of Systematic Reviews. 2018; 10 ( 10 ): CD007161.
dc.identifier.citedreferenceChambrone L, Ortega MAS, Sukekava F, et al. Root coverage procedures for treating single and multiple recession-type defects: an updated Cochrane systematic review. J Periodontol. 2019; 90 ( 12 ): 1399 - 1422.
dc.identifier.citedreferenceU.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry. Patient-reported outcome measures. Use in Medical Product Development to Support Labeling Claims. Food and Drug Administration; 2009.
dc.identifier.citedreferenceIoannidis JP, Evans SJ, Gotzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004; 141: 781 - 788.
dc.identifier.citedreferenceZorzela L, Loke YK, Ioannidis JP, et al. PRISMA harms group. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016; 352: i157.
dc.identifier.citedreferenceLineberry N, Berlin JA, Mansi B, et al. Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective. BMJ. 2016; 355: i5078.
dc.identifier.citedreferenceAvery KN, Brookes ST, Richards H, et al. NIHR biomedical research Centre surgical innovation theme. Adverse event reporting in surgical trials and early phase studies: the need for new and joint perspectives. BMJ. 2017; 357: j1693.
dc.identifier.citedreferenceFriedman LS, Richter ED. Relationship between conflicts of interest and research results. J Gen Intern Med. 2004; 19 ( 1 ): 51 - 56.
dc.identifier.citedreferenceFriedman L, Friedman M. Financial conflicts of interest and study results in environmental and occupational Health Research. J Occup Environ Med. 2016; 58 ( 3 ): 238 - 247.
dc.identifier.citedreferenceCriss CN, MacEachern MP, Matusko N, Dimick JB, Maggard-Gibbons M, Gadepalli SK. The impact of corporate payments on robotic surgery research: a systematic review. Ann Surg. 2019; 269 ( 3 ): 389 - 396.
dc.identifier.citedreferencePisinger C, Godtfredsen N, Bender AM. A conflict of interest is strongly associated with tobacco industry-favourable results, indicating no harm of e-cigarettes. Prev Med. 2019; 119: 124 - 131.
dc.identifier.citedreferenceCherla DV, Viso CP, Olavarria OA, et al. The impact of financial conflict of interest on surgical research: an observational study of published manuscripts. World J Surg. 2018; 42 ( 9 ): 2757 - 2762.
dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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