Changes in patient screening for a clinical study of dental implants after increased awareness of tobacco use as a risk factor

J Oral Maxillofac Surg. 1997 Dec;55(12 Suppl 5):72-5. doi: 10.1016/s0278-2391(16)31200-9.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Data Interpretation, Statistical
  • Decision Making
  • Dental Implantation, Endosseous*
  • Dental Implants*
  • Dental Prosthesis Design
  • Dental Restoration Failure
  • Humans
  • Osseointegration
  • Patient Selection*
  • Prospective Studies
  • Research Design
  • Risk Factors
  • Safety
  • Smoking / adverse effects*
  • Treatment Outcome

Substances

  • Dental Implants