title: Changes in patient screening for a clinical study of dental implants after increased awareness of tobacco use as a risk factor.
abstract: Independent external monitoring committees are an important part of scientific clinical trials. They monitor patient safety, study progress, investigators' performance, and accurate interpretation/reporting of the study data. Data trends observed by a study monitoring committee detected a change in the pattern of patient screening by investigators after an increased awareness that tobacco use could directly compromise the osseointegration of root-form dental implants. This increased awareness is believed to have altered the number of active smokers accepted into a multicenter prospective dental implant study. Recent data analyses indicate that the success ratios were improved by alterations in this discretionary inclusion-exclusion criterion.
authors.affiliation: Departments of Biomaterials and Surgery, School of Dentistry and Medicine, University of Alabama at Birmingham, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Lemons
authors.forename: D M
authors.initials: DM
authors.lastname: Laskin
authors.forename: W E
authors.initials: WE
authors.lastname: Roberts
authors.forename: D P
authors.initials: DP
authors.lastname: Tarnow
authors.forename: C
authors.initials: C
authors.lastname: Shipman
authors.forename: C
authors.initials: C
authors.lastname: Paczkowski
authors.forename: R E
authors.initials: RE
authors.lastname: Lorey
authors.forename: C
authors.initials: C
authors.lastname: English
mesh_terms: D003627:Data Interpretation, Statistical; D003657:Decision Making; D003758:Dental Implantation, Endosseous; D015921:Dental Implants; D017267:Dental Prosthesis Design; D019232:Dental Restoration Failure; D006801:Humans; D016348:Osseointegration; D018579:Patient Selection; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D012449:Safety; D012907:Smoking / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D015921:Dental Implants