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.