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A Report on the NIH Consensus Development Conference on Diagnosis and Management of Dental Caries Throughout Life

National Institute of Dental and Craniofacial Research, National Institutes of Health, Bldg. 45, Rm 3AN-44B, Bethesda, MD 20892, USA; alice.horowitz{at}nih.gov

KEY WORDS: caries • NIH Consensus Development Conference

	INTRODUCTION

TOP INTRODUCTION DISCUSSION REFERENCES

 
Initiated in 1977, the Consensus Development Program of the National Institutes of Health (NIH) is recognized as the premier health technology assessment and transfer program in the US. The program is managed by NIH’s Office of Medical Applications of Research (OMAR). OMAR, in collaboration with the various institutes of NIH and other Federal agencies, organizes major conferences that produce Consensus Statements in an attempt to resolve controversial health issues that are important to health care providers, the public, and policy-makers.

The process of selecting a topic for a Consensus Development Conference (CDC) includes a series of steps initiated by an appropriate NIH institute in collaboration with OMAR and other interested NIH institutes. The Director of the lead NIH institute and the Director of OMAR must agree upon the topic of a conference. Prior to making a decision, OMAR staff conducts literature searches to confirm that there is a sufficient research base on the topic to hold a CDC. When a topic area lacks sufficient supporting research, but is deemed significant because of a public health urgency or concern, an NIH State of the Science Conference may be held instead, which produces a State of the Science Statement (formerly known as a Technology Assessment Statement).

When the research evidence is sufficient to hold a consensus development conference, OMAR and the lead NIH institute form a planning committee. The planning committee for the dental caries consensus development conference included a diverse and knowledgeable group of 16 experts in the field of caries research and related fields representing Federal and academic institutions. The National Institute of Dental and Craniofacial Research (NIDCR) was the lead institute for the caries conference. It was co-sponsored by the National Institute on Aging and the US Food and Drug Administration.

Each NIH Consensus Development Conference addresses from four to six questions concerning efficacy, risk, diagnosis, and clinical applications of a procedure or regimen. One question is always directed at identifying recommendations for future research. Members of the planning committee finalize the questions and identify experts in the field who are invited to review and present the evidence before an independent panel consisting of non-Federal scientists and community members. OMAR convenes a consensus panel of 12 to 14 members for each CDC. Each potential member is screened to ensure that he or she has no vested interest in the topic. Prior to the conference, the appointed panel chair assigns one question to a team of two or three panel members who will have primary responsibility for reviewing the data for that specific question. All members, however, are responsible for reviewing all of the information. Approximately one month before the conference, OMAR holds a preliminary panel meeting. The purpose of this meeting is to ensure that the panel understands the process and to determine if any panel member needs additional information. In the case of the caries CDC, panel members were provided copies of all of the draft manuscripts from the speakers, all abstracts, and a literature search conducted by the National Library of Medicine, NIH. Several of the panel members requested additional information, which was provided.

During a day and a half of scientific presentations, the panel members listen to the evidence presented by the expert reviewers, ask questions, and engage in discussions. After all evidence is presented, the panel convenes to draft statements that answer each of the questions developed by the planning committee. On the morning of the third day, the draft statement is first presented to the panel and conference participants, where public comment is made and noted by the members of the panel. The panel then recesses, and the statement is modified based on the comments of the participants and subsequently is presented to the press. At this session, only the press is allowed to ask questions of panel members. Minor editing of the statement is done then, and it is distributed widely to health practitioners, policy-makers, patients, the media, and the public. The final consensus statement is available to anyone, both in printed form and from an NIH Web site. In addition, the statement is published in an appropriate journal. The caries CDC statement was first published in the Journal of the American Dental Association, and, subsequently, it was published with all of the conference manuscripts in the Journal of Dental Education. Once published, NIH consensus development statements are reviewed every few years to determine whether they need to be updated.

Diagnosis and Management of Dental Caries Throughout Life was the first NIH consensus development conference that addressed dental caries. The planning committee formulated the following six questions:

1. What are the best methods for detecting early and advanced dental caries (validity and feasibility of traditional methods; validity and feasibility of emerging methods)?
   
2. What are the best indicators for an increased risk of dental caries?
   
3. What are the best methods available for the primary prevention of dental caries initiation throughout life?
   
4. What are the best treatments available for reversing or arresting the progression of early dental caries?
   
5. How should clinical decisions regarding prevention and/or treatment be affected by detection methods and risk-assessment?
   
6. What are promising new research directions for the prevention, diagnosis, and treatment of dental caries?
   

This presentation will focus on questions 1 and 6, which are most relevant to this workshop. It is important to point out that, at the time the planning committee met for the caries conference, OMAR had used systematic reviews for only a few of its consensus development conferences and had plans to institutionalize the process for all future consensus development conferences. Because of this pending implementation, and because the NIDCR was interested in pursuing systematic reviews in several different content areas, this process was used for the caries conference. Although the NIDCR has sponsored many consensus development conferences since their inception, the caries conference was the first time systematic reviews were used. These reviews were conducted in two ways. First, the Evidence-based Practice Center Program, University of North Carolina and Research Triangle Institute (UNC/RTI), co-funded by the NIDCR and the Agency for Healthcare Research and Quality, conducted systematic reviews on parts or all of three of the questions generated by the planning committee. Dr. James Bader, the primary author of the review, presented their findings during the conference (Bader, 2001). In addition, 13 speakers discussed or reacted to his report. Of the 13 discussants, five specifically addressed diagnostic issues (Banting, 2001; Dove, 2001; Kidd, 2001; Pitts, 2001; Rosenstiel, 2001). These discussants prepared their own critical reviews and presented their interpretations of the findings of the UNC/RTI review during the conference.

For the remaining questions posed by the planning committee, a group of experts was trained to follow a systematic review protocol developed for the consensus development conference (Ismail, 2000). The training consisted of 3 days, organized into two sessions held in Bethesda. The NIDCR contracted with Dr. Amid Ismail to lead these sessions. In the first session, the process for developing questions for the reviews was presented, after which reviewers prepared a short list of questions specific to their assigned topic. During the second session, the questions were refined, and the process for searching, abstracting, and summarizing evidence was presented. A librarian from the University of Michigan experienced in conducting searches for systematic reviews was retained by contract to conduct the searches for these reviews. The search filters, evidence, and abstracts used by the reviewers have been published in the Journal of Dental Education and on the NIDCR Web site (Anderson, 2001). All of these reviews were peer-reviewed prior to the conference. However, because of limitations of time during the conference, discussion papers were not commissioned for these systematic reviews.

A specific question addressed by the UNC/RTI pertinent to the present workshop was: What are the validities of the available methods for detecting caries lesions in teeth? The UNC/RTI review and discussants of the review, as well as the independent reviewers, identified numerous limitations or problems with evidence that was relevant to the question. Most apparent, perhaps, was that too few studies used the same criteria for identifying caries lesions, which ranged from visual only to the use of adjunctive devices, including visual-tactile, radiography, fiber-optic transillumination (FOTI), electrical conduction, laser fluorescence, or various combinations of these technologies. In addition, most studies reported data only for cavitated lesions, thereby excluding early lesions that can be remineralized. Moreover, methods of training examiners were frequently neither mentioned nor described in enough detail to replicate. Similarly, methods of conducting examinations, detailing how examiners were calibrated and standardized, were inconsistent or missing. Most studies involved the crowns of permanent teeth of children, and few studies included primary teeth or root surfaces; many were under-powered and improperly controlled. The review found a dearth of evidence on the validity of the diagnosis of root caries. Overall, strength of evidence was rated as poor.

A major limitation of any review of the evidence on diagnosis of caries is the lack of a suitable in vivo gold standard. The gold standard of requiring histological confirmation used by the UNC/RTI team was criticized not only by conference participants but also by members of the CDC panel and several discussants (Kidd, 2001; Pitts, 2001; Statement, 2001). Several related questions have been posed—for example: Should a gold standard be validated? If yes, just how do we validate a gold standard? Further, should a gold standard that cannot be used in a clinical setting be used? In other words, histologic validation limits in vivo studies to 3rd molars and bicuspids. It is legitimate to ask, Who will adhere to gold standards that use histological examination of extracted third molars or bicuspids, which are not typical of teeth most susceptible to decay? Further, as noted by Kidd (2001), using a histological gold standard does not indicate current caries status; it portrays past decay only, not activity of a lesion.

For the diagnostic question, the UNC/RTI review delineated three possible ratings for their reviews: good, fair, or poor. The conclusions from the UNC/RTI review on validity of caries diagnosis included:

1. Few assessments were found for the performance of any diagnostic method of dental caries for primary or anterior teeth, and no assessments were found of performance on root surfaces; thus, the strength of the evidence for these teeth and surfaces was rated as poor.
   
2. Assessments of visual/tactile, FOTI, and laser fluorescence methods for diagnosing lesions in proximal and occlusal lesions were rated as poor because of the few studies available.
   
3. Assessment for radiographic, visual, and electrical conductance methods also was rated as poor for all types of lesions on posterior and proximal and occlusal surfaces.
   

After reviewing all of the evidence, the panel members made the following statements regarding the best methods for diagnosing dental caries:

• Existing diagnostic modalities require stronger validation.
  
• New diagnostic modalities are needed with appropriate sensitivities and specificities for different sites.
  
• It is unlikely that any one diagnostic modality will have adequate sensitivity and specificity of detection for all tooth surfaces.
  
• The literature is weak with regard to diagnosing root-surface dental caries and caries adjacent to restorations.
  
• The use of an explorer in detecting occlusal caries appears to add little information and may be detrimental.
  
• Existing diagnostic modalities appear to be satisfactory for diagnosing overt, cavitated lesions but are inadequate to diagnose non-cavitated lesions, root-surface lesions, or secondary caries efficaciously.
  

Specific recommendations for research included:

• Research into diagnostic methods, including established and new devices and techniques, is needed. Development of standardized methods of calibrating examiners is also needed.
  
• Clinical trials of established and new treatment methods are needed. These should conform to contemporary standards of design, implementation, analysis, and reporting. They should include trials of efficacy.
  

	DISCUSSION

TOP INTRODUCTION DISCUSSION REFERENCES

 
The results of the consensus development conference, Diagnosis and Management of Dental Caries Throughout Life, held in Bethesda, Maryland, in March, 2001, are clearly related to this International Consensus Workshop on Caries Clinical Trials (ICW-CCT). The members of the CDC panel suggested that although the science of clinical research design has advanced rapidly in recent decades, the design and execution of caries trials and epidemiologic studies have not kept up with current standards. The ICW-CCT has the potential to lay the groundwork for developing solutions to some of the deficiencies in diagnosing dental caries and perhaps for developing strategies for achieving the solutions. One thing is critical: Everyone working in clinical caries research should be "on the same page". That is, if an objective is to increase the quality and consistency of dental caries clinical trials throughout the world, then we must work together on solving the problems and share the resultant information broadly. In that way, researchers from all countries would have the potential of increasing the quality of dental caries clinical trials, and future systematic reviews would have more data upon which to assess a particular modality. Moreover, improved caries detection and diagnostic methods would help determine appropriate boundaries that separate clinical decisions to do nothing or to do something preventively or to restore cavitated carious teeth.

In preparing for the NIH consensus development conference on dental caries, it became patently clear that if systematic reviews are to be the basis of NIH consensus development conferences, we need to educate researchers throughout the world in these methods and introduce the methods to our students. Perhaps one of the major values of the NIH consensus development conference was to identify a dental caries research agenda, with an emphasis on the need to establish and validate methods of diagnosis of dental caries as well as the need for trials of both existing and new interventions. Further, we anticipate a new and vigorous focus on dental caries research. We need improved methods of assessing risk and diagnosing dental caries to make progress in eliminating this disease. This effort is particularly important with regard to diagnosing and managing incipient lesions, especially among those who are most vulnerable and have least access to preventive regimens and treatment.

	FOOTNOTES

 
Presented at the International Consensus Workshop on Caries Clinical Trials, Glasgow, Scotland, January 7–10, 2002

	REFERENCES

TOP INTRODUCTION DISCUSSION REFERENCES

 
Anderson PF (2001). Search strategies for independent reviewers. J Dent Educ 65:1169–1179.[Medline]

Banting DW (2001). The diagnosis of root caries. J Dent Educ 65:991–996.[Abstract]

Bader J (2001). Diagnosis and management of dental caries. Number 36. AHRQ Publication No. 01-E055, February, 2001. Rockville, MD: Agency for Healthcare Research and Quality, http://www.ahrq.gov/clinic/dentsumm.htm.

Consensus Development Conference statement, National Institutes of Health : Diagnosis and Management of Dental Caries Throughout Life (2001). J Am Dent Assoc 132:1153–1161.[Abstract/Free Full Text]

Kidd EA (2001). Diagnosis of secondary caries. J Dent Educ 65:997–1000.[Abstract]

Pitts NB (2001). Clinical diagnosis of dental caries: a European perspective. J Dent Educ 65:972–978.[Abstract]

Proceedings, diagnosis and management of dental caries throughout life (2001). J Dent Educ 65:935–1179.[Medline]

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