title: An analysis of studies on piezoelectric surgery in the oral and craniomaxillofacial region with regard to human subject protection and financial conflicts.
abstract: This retrospective, observational study investigated whether published studies on the use of piezoelectric surgery (PS) in the oral and craniomaxillofacial region fulfilled the requirements of the International Committee of Medical Journal Editors (ICMJE) and the Declaration of Helsinki (DoH) with respect to human subject protections (HSP) and disclosure of financial conflicts (FC). A Medline/PUBMED search was performed in April 2008 to identify all clinical studies on PS, published in English, French and German. Disclosure of HSP (obtaining ethical approval and subjects' informed consent) and FC mentioned in the retrieved articles were analysed. 29 clinical articles were identified in 18 journals, of which 14 journals (78%) required the disclosure of both HSP and FC. Ethical approval was documented in two studies (7%); patient consent was reported in four publications (14%). Four articles disclosed no FC. 21 reports (72%) mentioned neither HSP nor FC. The relationships between funding source and study outcomes could not be identified. Most studies on the use of PS hardly adhered to the regulations recommended by the ICMJE and DoH, and do not mention HSP and FC, indicating the study results with a high degree of suspicion. It is recommended that oral and craniomaxillofacial surgery journals adhere strictly to these regulations because they carry a heavy responsibility regarding the scientific integrity of publications in this specialty.
authors.affiliation: Department of Maxillofacial Surgery, AP-HP, Pitié-Salpêtrière University Hospital, Faculty of Medicine, University Paris 6 (Pierre et Marie Curie), Paris, France. poramate.pitakarnnop@gmail.com
authors.forename: P
authors.initials: P
authors.lastname: Pitak-Arnnop
authors.forename: A
authors.initials: A
authors.lastname: Hemprich
authors.forename: R
authors.initials: R
authors.lastname: Sader
authors.forename: K
authors.initials: K
authors.lastname: Dhanuthai
authors.forename: J-Ch
authors.initials: JC
authors.lastname: Bertrand
authors.forename: C
authors.initials: C
authors.lastname: Hennig
authors.forename: C
authors.initials: C
authors.lastname: Hervé
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D016265:Conflict of Interest; D035081:Editorial Policies; D004990:Ethics, Dental; D032984:Ethics, Research; D005378:Financial Support / Q000941:ethics; D019983:Guideline Adherence; D006381:Helsinki Declaration; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D056948:Orthognathic Surgical Procedures / Q000941:ethics* / Q000592:standards; D011643:Publishing / Q000941:ethics* / Q000592:standards; D035842:Research Subjects; D012189:Retrospective Studies; D014464:Ultrasonic Therapy / Q000941:ethics* / Q000592:standards