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Clinical Research

Levels of Evidence for the Outcome of Nonsurgical Endodontic Treatment


Mahmoud Torabinejad, DMD, MSD, PhD,* Diana Kutsenko, DMD, Tanya K. Machnick, DDS, MS, Amid Ismail, BDS, MPH, DPH, and Carl W. Newton, DDS, MSD
Abstract
The purpose of this systematic review was (a) to search for clinical articles pertaining to success and failure of nonsurgical root canal therapy, and (b) to assign levels of evidence to these studies. Electronic and manual searches were conducted to identify studies published between January 1966 and September 2004 with information on the success and failure of nonsurgical root canal therapy. Articles were reviewed and graded for strength of level of evidence (LOE) from one (highest level) to five (lowest level). This review resulted in the identification of 306 clinical studies related to this topic area. Six articles were randomized controlled trials (RCTs, LOE 1). This search also identified 12 low-quality RCTs (LOE 2), 14 cohort studies (LOE 2), five casecontrol and eight cross sectional studies (LOE 3), four low-quality cohort studies (LOE 4), and five low-quality case-control studies (LOE 4). The majority (73) of the often-quoted success and failure studies were case series (LOE 4). The rest of the articles were descriptive epidemiological studies (42), case reports (114), expert opinions (18), literature reviews (4), and one metaanalysis. Based on these findings, it appears that a few high-level studies have been published in the past four decades related to the success and failure of nonsurgical root canal therapy. The data generated by this search can be used in future studies to specifically answer questions and test hypotheses relevant to the outcome of nonsurgical root canal treatment.

Key Words
Outcome, endodontics, clinical trials, systematic review

From the *Department of Endodontics of the School of Dentistry, Loma Linda University, Loma Linda, California; Private practice; Private practice; Department of Cariology, Restorative Sciences, and Endodontics at the School of Dentistry and Department Epidemiology, School of Public Health, University of Michigan, Michigan; Department of Endodontics, Indiana University School of Dentistry, Indiana. Address request for reprints to Dr. Mahmoud Torabinejad, Professor and Director, Endodontic Residency Program Department of Endodontics School of Dentistry Loma Linda University Loma Linda, CA 92350. E-mail address: mtorabinejad@sd.llu.edu. Copyright 2005 by the American Association of Endodontists

hen the dental pulp undergoes pathologic changes because of trauma or the progression of dental caries, bacteria and other irritants from the oral cavity invade the root canal system. The major objectives of root canal therapy are removal of pathologic pulp, cleaning, and shaping of the root canal system, disinfection of contaminated root canals, and obturation of the root canal system in three dimensions to prevent reinfection. Adherence to these treatment objectives should result in maintaining normal radiographic and clinical conditions in teeth without preoperative periradicular lesions. Similar radiographic and clinical outcomes are expected in teeth with preoperative periradicular lesions when the same principles are practiced during root canal therapy. When a clinician is involved in treatment planning with a patient, the following questions must be answered: What is the success rate of root canal therapy? What evidence is available? How is it compared to alternative treatment modalities? And finally, can the outcomes of root canal therapy be compared with that of alternative treatments? If the decision must be made whether to save a natural tooth by performing root canal therapy, a patient has the right to know the prognosis of the proposed treatments to make an informed decision. The parties involved (patients, dentists, insurance companies) have different perspectives and expectations regarding the outcome of root canal treatment. Patients are usually content as long as their teeth are functionally and esthetically pleasing, insurance companies may measure success by survival rate of endodontically treated teeth, and endodontists are usually most concerned with the absence of disease clinically and radiographically. Clinical and radiographic examinations are the most common procedures that are used to determine outcomes of root canal therapy. As far back as 1966, Bender and co-workers (1) identified some of the factors that could affect the success of root canal treatment. They noted that radiographic interpretation is often subject to personal bias and that a change in angulations can often give a completely different appearance to the lesion, making it appear either smaller or larger. They also discussed the fact that clinical symptoms such as pain, swelling, and presence of a sinus tract can occur without radiographic evidence of bone destruction. In addition, they indicated that not all radiolucencies located in the periapical area are of pulpal origin, and that some of these lesions are caused by systemic conditions. Most previous nonsurgical root canal studies have used various criteria to determine success; therefore, the success rates from one study cannot be compared to those of another study. Currently, the only way to evaluate the outcomes of different techniques and materials is to approximate the findings of one study with another. For example, it is possible to find some level of evidence to justify using various filling techniques, but very little exists to conclusively prove one method is superior to others. Recently, there has been a movement towards evidence-based dentistry to scientifically evaluate the effectiveness of the treatments that are performed clinically. The term evidence based medicine was coined at McMaster Medical School in Canada in the 1980s to label this clinical learning strategy, which people at the school had been developing for over a decade (2). The purpose of developing this approach was to allow clinicians to use research findings as the basis for clinical decisions (3). Many clinicians continue to base their clinical decisions on increasingly outdated primary training, or the over-interpretation of experiences with individual patients (4).

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TABLE 1. The MeSH terms related to success and failure of nonsurgical root canal therapy used for MedlinePlus search
(Exp Endodontics/ or exp Dental Pulp Diseases/ or exp Periapical Diseases/ or exp Root Canal Filling Materials/ or Dental Pulp Test/ or Dental Pulp/ or Dental Pulp Cavity/) or (root canal.mp. or apicectom:.mp. or apicoectom:.mp. or (dead adj3 (teeth or tooth)).mp. or (dental adj3 pulp:).mp. or endodont:.mp. or endont:.mp. or endosonic.mp. or ((lateral or vertical) adj condensation).mp. or ((non-vital or nonvital) adj3 (teeth or tooth)).mp. or obtura.mp. or obturation.mp. or obturate.mp. or (pulp adj3 (capping or therap: or extirpation:)).mp. or (pulp adj (canal$1 or chamber$1)).mp. or pulpectomy.mp. or pulpotomy.mp. or replantation.mp. or (root adj end adj5 fill:).mp. or ((silver or gutta) adj3 (percha or balata).mp. or (silver adj (cone$1 or point$1)).mp. or thermafil.mp. or trans-polyisoprene.mp. or transpolyisoprene.mp. or ultrafil.mp.) or ((periradicular or radicular or periapical or apical).mp. and (exp tooth/ or exp tooth components/)) or (hemisection:.mp. not (spine or spinal).mp.)) and (Clinical Protocols/ or exp Clinical trials/ or exp Patient Care Management/ or Patient Selection/ or Practice Guidelines/ or clinic:.mp. or (recall adj3 appointment$1).mp. or ((patient or research) adj3 (recruitment or selection)).mp. or (selection adj3 (criteria or treatment or subject$1)).mp. or (treatment adj protocol$1).mp. or ra.fs. or radiograph:.mp. or ah.fs. or histolog:.mp. or (nonsurg: or non-surg:).mp.) and (exp Disease progression/ or exp Morbidity/ or exp Mortality/ or exp Outcome assessment (health care)/ or exp Patient satisfaction/ or exp Prognosis/ or exp Survival analysis/ or exp Time factors/ or exp Treatment outcome/ Or co.fs. or course.mp. or (inception adj cohort$1).mp. or (natural adj History).mp. or outcome$1.mp. or predict$.mp. or prognos$.mp. or Surviv$3.mp. or fail$5.mp. or longevity.mp. or durability.mp. or Succes:.mp. or exp Case-control studies/ or exp Cohort studies/ or exp Comparative study/ or Retreatment/ or Recurrence/ or (retreat: or Revis:).mp.)) not ((Dentition, Primary/ or Child, Preschool/ or Child/ or (immatur: adj3 (teeth or tooth)).mp. or (open adj3 (apex or apices or Apexes)).mp. or blunderbuss.mp.) not (Dentition, Mixed/ or Dentition, Permanent/ or Adolescent/ or exp Adult/ or (mature adj3 (teeth or Tooth)).mp. or (closed adj3 (apex or apices or apexes)).mp.))) not (Animal/ not Human/)) limit 1 to english language

The concept of evidence-based healthcare has gained strength in the last decade. All branches of healthcare now subscribe to the evidence-based philosophy. However, evidence-based practice requires the availability of primary research to answer the clinical questions that practitioners face in their practices. Evidence-based dentistry (EBD) is a new approach to oral healthcare that integrates the best clinical evidence to support a practitioners clinical expertise for each patients treatment needs and preferences. The American Dental Association has outlined four steps for evidence-based dental practice (5). The first step defines a clinically relevant and focused question in the interest of finding the best available evidence to promote the oral health of patients. The second step focuses on systematically conducting searches for all studies to determine the gaps in the knowledge related to a specific question. The third step of the EBD process is to translate the findings from systematic reviews for use by practitioners. The final step of the EBD process assesses the healthcare outcomes following the findings of the previously outlined steps. A review of current literature shows absence of comprehensive information regarding the design and quality of studies related to the outcome of nonsurgical root canal therapy. The purpose of this systematic review was (1) to search for clinical articles pertaining to success and failure of nonsurgical endodontics, and (2) to assign levels of evidence to these studies.

Methods
MEDLINE, a search tool of the National Library of Medicine served as our primary computerized database. A search strategy was developed to identify articles in MEDLINE dealing with success and failure of nonsurgical root canal therapy from January 1966 through September 2004. Additionally, text words describing different endodontic treat638

ments and phrases related to the success and failure of nonsurgical root canal therapy were used to allow for a broader capture of literature. The detailed search strategy is shown in Table 1. An endodontist and an information expert selected search concepts and terms jointly. Before the search was performed, the endodontist identified 13 core articles that should be retrieved by the final search. The presences of these core articles in the search results were used as a criterion to validate the accuracy of the final MEDLINE search strategy. In addition to MEDLINE, EMBASE, and the Cochrane Library were also searched, with the MEDLINE search strategy modified substantially to suit the unique structures and content of these different databases. The EMBASE database does not include many of the MeSH headings used in the MEDLINE search, and they are structured differently, making it necessary to substantially enrich the free text terms used in the search. The Cochrane database is smaller in size and more focused in scope, making it unnecessary to include the breadth of free text terms or methodology descriptors. The searches included human studies and reviews in the English language, which contained clinical, radiographic, histological, or microbiologic information on the outcome of nonsurgical root canal therapy. Initially, the titles of all articles were printed and screened. Based on our inclusion criteria, a group of articles was selected for closer examination. The abstracts of these articles were then reviewed for inclusion based on the following criteria: 1. Success and failure, such as periapical healing or persistence of a lesion; 2. The success rate of endodontics in a specified population (epidemiological study); 3. The success rate of a unique case followed over time; 4. Clinical success as described by an expert.

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Articles that simply described a clinical technique or studies that did not have a follow-up of 1-yr after initial treatment were excluded from the search body. Articles that addressed a short-term success and failure, such as presence or absence of pain, were reviewed but not included in the final results. In addition to the electronic searches, we included the chapters regarding success and failure in Endodontics (6), Essential Endodontology (7), Pathways of the Pulp (8), and Principles and Practice of Endodontics (9). These chapters were reviewed and the articles that matched the search criteria were pulled and cross-referenced as described above. In addition to the literature in these textbooks, literature binders used by Graduate Endodontics at Loma Linda University were also included and subjected to the same review process as the other databases that were searched. For each reference that appeared to match the search criteria, the article was photocopied and reviewed by a team of five reviewers (four students and an endodontist). The reference section of each article was then studied to determine if any of the references cited in the article matched our search criteria. Each time a reference section was reviewed, the references were checked against a master list of articles already located using the search of the electronic databases. If an article did not appear on the master list, it was then pulled, reviewed and cross-referenced. This cross-referencing process (locating articles and studying the reference section) was continued until there were no longer any new articles located in either the electronic databases or through manual cross-referencing. The articles on the master list were then divided among five reviewers. All articles were read thoroughly, and a one-page abstraction sheet was written for each article that included the purpose, methods, results, and discussion. Once the abstracts were completed, the five evaluators stratified them jointly based on the levels of evidence (LOE). Two additional experienced faculty members in evidence-based dentistry confirmed these ratings later. This process confirmed the initial results and helped to ensure proper classification of the articles. The LOE from one to five was determined (Table 2). Level one included Randomized controlled trials (RCTs) and systematic reviews of randomized control trials, level two included low-level RCTs, Cohort studies and systematic review of cohort studies, level three included Case control and systematic reviews of case control studies, level four included low-level Cohort studies and Case series (noncomparative), and level five included Case reports, Expert opinion, and literature reviews. For each study that qualified as an RCT or a cohort study, a further series of questions (Tables 3 and 4) were answered to determine if the study was a high- or low-quality RCT or Cohort study. If most of the assessment criteria were not met for a study, it was lowered by one evidence level. In addition to the quality evaluation conducted using the criteria described in Table 3 for randomized controlled trials, an asTABLE 3. Validity assessment questions for clinical control trials (RCTs; LOE 1, or LOE 2)
1. 2. 3. 4. 5. Did the trial address a clearly focused issue? Is a trial (RCT) an appropriate method to answer this issue? How were patients assigned to treatment groups? Were staff and study personnel blind to treatment? Were all the participants who entered the trial properly accounted for at its conclusion? 6. Aside from experimental intervention, were the groups treated in the same way? 7. Did the study have enough participants to minimize the play of chance?
Adapted from Center for Evidence-based Medicine at Oxford.

TABLE 4. Validity assessment questions for cohort studies (LOE 2 or LOE 4)


1. 2. 3. 4. 5. 6a. 6b. 7a. 7b. Did the trial address a clearly focused issue? Did the authors use an appropriate method to answer this issue? Was the cohort recruited in an acceptable way? Was the exposure accurately measured to minimized bias? Was the outcome accurately measured to minimized bias? Have the authors identified all the important confounding factors? Have they taken account of the confounding factors in the design and/or analysis? Was the follow up of subjects complete enough? Was the follow up of subjects long enough?

Adapted from Center for Evidence-based Medicine at Oxford.

sessment using some of the CONSORT guidelines (10, 11) was also used for these studies.

Results
The MEDLINE search produced 3,211 articles; the EMBASE search resulted in 1,677 articles, and the Cochrane Library provided 673 articles. The manual searches resulted in identification of 463 articles. The articles dealing with outcomes of nonsurgical endodontic treatment were selected based on their titles and abstracts. A total of 306 articles were finally classified as relevant to the question of the review. The criteria for success varied from study to study, and no attempt was made to standardize the definition of success. Of the 306 clinical success and failure studies, there were six RCTs that is level of evidence 1 (1217). Our search identified 12 low quality RCTs (18 29), 14 cohort studies (30 43), corresponding to level of evidence 2, and five case-control studies (45 48) and eight cross sectional studies with the levels of evidence 3 (49 56). Level of evidence 4 includes four low quality cohort studies (57 60), five low quality case-control studies (61 65), 73 case series (66 138), and 42 descriptive epidemiological studies (139 180). Level of evidence 5 includes 114 case reports (181294), 18 expert opinion articles (1, 295311), four literature reviews (312315), and one meta-analysis (316). Table 5 shows levels of evidence, classification of various studies and the number of studies in each category.

TABLE 2. Evidence level stratification of relevant study designs


1 2 3 4 5 Randomized control trials (RCT) Systematic reviews of randomized control trials Low-quality randomized control trials Cohort studies Systematic review of cohort studies Case control studies Systematic reviews of case control studies Poor-quality cohort and case control studies Case series Case reports Expert opinion without explicit critical appraisal Literature reviews

Discussion
This paper presents a systematic review of the design and quality of studies that are published to answer the following clinical question: What are the designs, and what is the quality of success and failure studies of nonsurgical endodontic therapy? This question does not follow the standard PICO format (population, intervention, comparison, and outcomes) because this project, while it followed a systematic approach for searching for studies, is not a systematic review of a clinical question or an intervention. Rather, this study should be viewed as a 639

Adapted from Center for Evidence-based Medicine at Oxford.

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TABLE 5. LOE, Classification of various studies and the number of studies in each category LOE
1 2 3 4 5 Total

Classification of Various Types of Studies


Randomized control trials (RCT) Systematic reviews of randomized control trials Low-quality randomized control trials Cohort studies Systematic review of cohort studies Case control studies Systematic reviews of case control studies Poor-quality cohort and case control studies Case series Case reports Expert opinion without explicit critical appraisal Literature reviews

Number of Studies
6 26 13 124 137 306

survey of clinical evidence and development of a database to be used by residents, teachers and researchers. The data created by this search can be used in future studies to specifically answer clinically relevant questions and test hypotheses (i.e. in patients with endodontically treated teeth, does the quality of the coronal restoration result in a better outcome? Does single- or multiple-appointment treatment result in a better outcome? Does the use of systemic antibiotics before, during or after treatment result in a better outcome?). The three search engines used in this study were the MEDLINE, EMBASE, and Cochrane Library. The utilization of these search engines should have allowed for the broadest capture of the literature related to success and failure of nonsurgical root canal therapy. The MEDLINE is a search strategy for the National Library of Medicine computerized bibliographic database. The EMBASE database is the European equivalent of MEDLINE, and is primarily surgical and pharmaceutical in scope. Because of the relative poverty of endodontic terms in EMBASE, the search strategy was revised to emphasize text word searching rather than structured-vocabulary searching. The Cochrane Library is a highly selective database of expert-selected articles, primarily high-quality clinical studies. While the database itself in Cochrane is much smaller than either MEDLINE or EMBASE, the content is of superior quality overall. This search strategy was simpler since the database content was already focused on clinical research concepts. Despite extensive searching, some articles may still have been missed during the electronic or manual search of published studies. The rating of levels of evidence was initially performed as a group to avoid the bias of single reviewer and to promote discussion about the rating process itself. Participation of two experienced faculty members in evidence-based dentistry later helped to ensure proper classification of the articles. A large proportion of articles located in our initial search were on pain. Ninety-nine of these studies were identified; these articles were eliminated from our review, because they only take into account the short-term success of treatment, and not the long-term success rate. Pain articles may dominate the field because of the interest of clinicians, patients and pharmaceutical companies in this subject. In addition, pain studies are usually of short duration and are easier to conduct compared to those requiring long-term follow-ups. Examination of the data from our search shows variability in material composition, treatment procedures and evaluation criteria. We found six studies with the highest level of evidence (LOE 1). Begg and co-workers developed the Consolidated Standards for Reporting of Trials (CONSORT) statement to help improve the quality of reports of RCTs in medicine (10). Moher and co-workers compared reports prepared pre-CONSORT with reports prepared post-CONSORT and found that the use of the CONSORT statement was associated with improved quality of 640

reports of RCTs (11). The quality characteristics of randomized controlled trials included in this assessment are: description of inclusion/ exclusion criteria; definition of outcomes; sample size; randomization protocol; concealment of allocation; masking of evaluators; and follow-up rates of participants. Application of CONSORT guidelines to the six studies with the highest level of evidence (LOE 1) reveals some deficiencies in these articles (1217). The CONSORT guidelines should be used for the future RCTs in endodontics. Predictors of success and failure can be divided into preoperative, intraoperative and postoperative factors. The preoperative factors include age, gender, tooth location, presence or absence of lesions, lesion size, pulp status, symptoms, and periodontal condition. The intraoperative factors include quality of cleaning, shaping, and obturation, size of apical enlargement, culturing, number of appointments, materials and techniques used during root canal therapy, accidental procedures and flare-ups. The major postoperative factor that can affect the outcome of root canal treatment is restoration of endodontically treated teeth. Except for very few predictive factors, presence or absence of a lesion (29, 38, 92, 99), or placement of a final restoration following root canal therapy (50, 51, 53, 170, 177), the present data shows absence of consistent relationship between most of these factors and outcomes of root canal therapy. The lack of relationship between these factors and outcomes of root canal therapy could be a real phenomenon, or it could be a result of the designs of currently available data and the absence of randomized clinical trials related to this subject. The randomization process usually results in equal distribution of contributing factors and prevents experimental biases. The majority of well-known success and failure studies are actually nonrandomized and not controlled case series, which are assigned as evidence, level four. We found similar results when searches were conducted to determine the levels of evidence for articles related to surgical endodontics or re-treatment of failed nonsurgical root canal therapy (317, 318). These findings do not mean that the current modalities of endodontics are not successful or have no evidence to support them. This has occurred as a result of the nature of root canal treatment and lack of comparative treatment modalities similar to it. Based on available studies that offer the best evidence, it appears 92 to 98% of teeth without periapical lesions remain free of disease after root canal therapy (315). These studies also show 74 to 86% of teeth with apical lesions completely heal after initial treatment or retreatment. In addition, similar data shows that 91 to 97% of teeth that have had root canal treatment remain functional over time (315). There are fundamental differences in: indications and contraindications, procedures and techniques involved, factors affecting success and failure, criteria used to determine success and failure of root canal therapy, and treatment options following unsuccessful root canal treat-

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ment compared to those for alternative treatments such as implants. The indication for an alternative treatment such as an implant is usually when a tooth cannot be saved and treated with root canal therapy. In other words, a contraindication of root canal therapy is an indication for placement of an implant. The procedures involved in the two treatment modalities are also different. Initial root canal treatment does not involve surgical procedures, and teeth can be restored immediately following the treatment. Implant dentistry involves surgical procedures, and final restorations cannot be placed in most cases immediately following the placement of implants. Furthermore, the criteria that have been used for success and failure studies in root canal therapy have been more stringent than those applied for the outcomes of implants. When survival rate (functional teeth with or without radiographic lesions) for endodontically treated teeth is used instead of the traditional criteria, the success rate of endodontically treated teeth by endodontists is equal or better than the long term outcome of implants (60). Treatment options following unsuccessful root canal therapy are retreatment and/or endodontic surgery. In contrast, the treatment option for a failed implant is its removal and the possible placement of another implant. Because of these differences and ethical issues, it is very difficult to design clinical studies that would, in a randomized fashion, examine the success rate of root canal therapy compared to alternative treatment modalities such as implants. Evidence-based dentistry, as defined by the American Dental Association (5), is . . . an approach to oral health care that requires the judicious integration of systematic assessments of clinically relevant scientific evidence, relating to the patients oral and medical condition and history, with the dentists clinical expertise and the patients treatment needs and preferences. This definition implies that there are two important components in an evidence-based practice. The first is the systematic assessment of scientific evidence, and the second is use of the findings from systematic reviews to form clinical decisions that take into account the dentists clinical skills and the preferences of patients. Scientific evidence by no means refers only to randomized controlled trials, but rather to the goal of systematic reviews, which is to find the best evidence. Endodontists provide a highly valuable healthcare service to patients suffering from pulpal and periradicular diseases. Despite the absence of evidence at the highest levels, the long-term healing of periradicular pathosis and the preservation of millions of teeth every year underscore the success of the current modalities of root canal therapy. Conducting research projects at the highest levels of evidence (when possible) will strengthen current data. Based on the results of this systematic review, it appears that a few high-level studies have been published in the past four decades related to the success and failure of nonsurgical root canal therapy. The data created by this review can be used for future studies to specifically answer questions and test hypotheses relevant to the outcome of nonsurgical root canal treatment.
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Acknowledgments
We would like to thank Drs. S. Garber and L. Stromberg, former residents in the Department of Endodontics, School of Dentistry, Loma Linda University, who assisted us with the initiation of this project. In addition, we would like to thank Patricia Anderson for conducting literature searches, and Dr. Khaled Bahjri for his assistance with the evaluation of the levels of evidence regarding this project.

References
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