The issue of final apical preparation size remains controversial despite considerable clinical and in vitro research. The astute clinician must be aware of this research before choosing any instrumentation system because the informed clinician's decision must be guided by the best available evidenced-based information. This review article generated a Medline-based search strategy to disclose these studies and provides a critique and summary of the results.From the University of Pittsburgh School of Dental Medicine, Pittsburgh, Pennsylvania.Address request for reprints to Dean Baugh, DDS. E-mail address: baughdf@yahoo.com.Copyright © 2005 by the American Association of Endodontists T he most important objective of root canal therapy is to minimize the number of microorganisms and pathologic debris in root canal systems to prevent or treat apical periodontitis. This process of chemomechanical debridement, or cleaning of the root canal systems, has been described as the removal of all of the contents of the root canal systems before and during shaping. Grossman (1) described mechanical cleaning as the most important part of root canal therapy. Schilder (2) also considered cleaning and shaping as the foundation for successful endodontic therapy.Thorough instrumentation of the apical region has long been considered to be an essential component in the cleaning and shaping process. It was discussed as a critical step as early as 1931 by Groove (3). Simon (4) later recognized the apical area as the critical zone for instrumentation. Other authors (5, 6) concluded that the last few millimeters that approach the apical foramen are critical in the instrumentation process. Mechanical instrumentation and irrigation are sound endodontic principles and essential components of successful endodontics (7,8). Research has shown that mechanical instrumentation greatly reduces the number of microorganisms remaining in the root canal system. Mechanical instrumentation (9) has been shown to reduce bacterial count even without irrigants or dressings. A combination of mechanical instrumentation and irrigation (9, 10) further reduced the number of microorganisms by 100 to 1000 times. However, mechanical instrumentation with irrigation does not reliably disinfect an infected root canal system (11-14).Manufacturers developed nickel-titanium rotary instrumentation systems to facilitate the cleaning and shaping process. They are popular because of their apparent ease of use and reduced number of instruments. However, Spangberg (6) noted that the strong emphasis on reducing the number of instruments and limiting apical preparations to small sizes does not produce clean apical preparations in diseased teeth. Given this controversial and important topic, we conducted a broad-based Medline search of the literature to characterize the major factors involved in apical canal instrumentation. Table 1 provides the Medline search strategy used to identify relevant articles for this review. A secondary search was then conducted using the refere...