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 sc ientific 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 d etected a change in the pattern of patient screening by investigators after an increased awareness that tobacco use could directly compromis e the osseointegration of root-form dental implants. This increased aw areness is believed to have altered the number of active smokers accep ted into a multicenter prospective dental implant study. Recent data a nalyses indicate that the success ratios were improved by alterations in this discretionary inclusion-exclusion criterion.