Changes in patient screening for a clinical study of dental implants after increased awareness of tobacco use as a risk factor.
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.
Lemons
J E
JE
Departments of Biomaterials and Surgery, School of Dentistry and Medicine, University of Alabama at Birmingham, USA.
Laskin
D M
DM
Roberts
W E
WE
Tarnow
D P
DP
Shipman
C
C
Paczkowski
C
C
Lorey
R E
RE
English
C
C
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
D015921:Dental Implants