While dental sealants have been recognized as an effective approach to preventing pit-and-fissure caries in children,1–5 clinical questions remain about the indications for placing pit-and-fissure sealants, the criteria for their placement over early caries (that is, noncavitated caries) and techniques to optimize retention and effectiveness. This report on the clinical recommendations for use of pit-and-fissure sealants presents a critical evaluation and summary of relevant scientific evidence to assist clinicians with their clinical decision-making process.
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USE OF SEALANTS: AN EVIDENCE-BASED APPROACH
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Dentistry is a dynamic profession, continually reshaped by new science, devices, techniques and materials, all of which have increased rapidly since many of todays practicing dentists were trained. During the past 30 years, evidence-based approaches have developed that involve rigorous summary of findings from clinical studies about the effectiveness of preventive and treatment strategies, with the aim of providing the best available information to clinicians for decision making. In a changing practice environment, it is important that educational institutions and providers of continuing education continually update the state of the evidence related to the effectiveness of sealants in dental caries prevention and management.
Clinical decision making reflects the intersection of science, professional judgment and patients desires. Decisions about sealant use should be based on the best available evidence about the effectiveness of the intervention and on knowledge of the epidemiology of dental caries (risk factors and patterns of disease). Therefore, this report includes a section addressing caries prevalence according to tooth surface and population group. This information should help to ensure that sealants are used appropriately within the context of these recommendations.
This report was developed through a critical evaluation of the collective body of published scientific evidence, conducted by an expert panel that was convened by the American Dental Association Council on Scientific Affairs. These clinical recommendations are not a standard of care, but rather a useful tool for dentists to use in making clinically sound decisions about sealant use. These clinical recommendations should be integrated with the practitioners professional judgment and the individual patients needs and preferences. While these recommendations are applicable to multiple settings, the Centers for Disease Control and Prevention (CDC) is developing recommendations for use of pit-and-fissure sealants specific for school-based programs.
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CARIES: DEFINITION AND PREVENTION
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Definition of dental caries.
This report defines caries as the manifestation of the stage of the caries process at any given point in time.6 The caries process occurs across time as an interaction between biofilm (that is, dental plaque) and the tooth surface and subsurface.6 The bacteria in biofilm are metabolically active, which causes fluctuations in plaque fluid pH. These fluctuations may cause a loss of mineral from the tooth when the pH level is dropping or a gain of mineral when the pH level is increasing.7,8 Progression occurs when the equilibrium between demineralization and remineralization is imbalanced, leading to a net mineral loss. In clinical care settings, diagnosis of caries implies not only determining whether caries is present (that is, detection) but also determining if the disease is arrested or active and, if active, progressing rapidly or slowly.7,9
Caries is an infectious oral disease that can be arrested in its early stages. Caries can be prevented and managed in many ways. Approaches include primary prevention, defined as interventions provided to avert the onset of caries, and secondary prevention, defined as interventions to avert the progression of early caries to cavitation.
Epidemiology.
In data from 2004, 42 percent of children and young adults aged 6 to 19 years had dental caries (decayed or filled) in their permanent teeth.10 Prevalence of dental caries increases with age, ranging from 21 percent among those aged 6 to 11 years to 67 percent among adolescents aged 16 to 19 years.10 The prevalence of dental caries is higher among children from low-income families and those of Mexican-American ethnicity.10 Overall, about one-quarter of carious surfaces remain untreated in children and young adults with any caries. About 90 percent of carious lesions are found in the pits and fissures of permanent posterior teeth.10 These data also indicate that around 40 percent of children aged 2 to 8 years have experienced dental caries (decayed or filled) in their primary teeth.10 Similar to the findings for the permanent teeth, the prevalence of dental caries and of untreated decay in the primary teeth is higher among children from low-income families and those of Mexican-American ethnicity.10 Overall, about one-half of carious surfaces remain untreated among children with any caries. About 44 percent of carious lesions in primary teeth are found on the pits and fissures of molars.10
The role of pit-and-fissure sealants in primary and secondary prevention.
Pit-and-fissure sealants can be used effectively as part of a comprehensive approach to caries prevention on an individual basis or as a public health measure for at-risk populations. Sealants are placed to prevent caries initiation and to arrest caries progression by providing a physical barrier that inhibits microorganisms and food particles from collecting in pits and fissures. It is generally accepted that the effectiveness of sealants for caries prevention depends on long-term retention.5,11,12 Full retention of sealants can be evaluated through visual and tactile examinations. In situations in which a sealant has been lost or partially retained, the sealant should be reapplied to ensure effectiveness.
Pit-and-fissure sealants are underused, particularly among those at high risk of experiencing caries; that population includes children in lower-income and certain racial and ethnic groups.13 The national oral health objectives for dental sealants, as stated in the U.S. Department of Health and Human Services initiative Healthy People 2010, includes increasing the proportion of children who have received dental sealants on their molar teeth to 50 percent.14 However, national data collected from 1999 through 2002 indicated that sealant prevalence on permanent teeth among children aged 6 to 11 years was 30.5 percent,15 but this represents a substantial increase over the 8 percent prevalence reported in a survey conducted in 1986 and 1987.16
Types of sealant materials and placement techniques.
Two predominant types of pit-and-fissure sealant materials are available: resin-based sealants and glass ionomer cements. Available resin-based sealant materials can be polymerized by autopolymerization, photopolymerization using visible light or a combination of the two processes.11
Glass ionomer cements are available in two forms, both of which contain fluoride: conventional and resin-modified.17 Glass ionomer cements, which do not require acid etching of the tooth surface, generally are easier to place than are resin-based sealants. They also are not as moisture-sensitive as their resin-based counterparts. Glass ionomer materials, which were developed for their ability to release fluoride, can bond directly with enamel. It is hypothesized that release of fluoride from this material may contribute to caries prevention. However, the clinical effect of fluoride release from glass ionomer cement is not well-established. Clinical studies have provided conflicting evidence as to whether these materials significantly prevent or inhibit caries and affect the growth of caries-associated bacteria compared with materials not containing fluoride.18–20
A transient amount of bisphenol-A (BPA) may be detected in the saliva of some patients immediately after initial application of certain sealants as a result of the action of salivary enzymes on bisphenol-dimethacrylate, a component of some sealant materials.21–24 According to research, systemic BPA has not been detected as a result of the use of such sealants, and potential estrogenicity at such low levels of exposure has not been documented.22
Pit-and-fissure sealant materials vary, as do the techniques used to place them. Manufacturers instructions for effective placement and long-term retention of resin-based sealants typically include cleaning pits and fissures, appropriately acid etching surfaces and maintaining a dry field uncontaminated by saliva until the sealant is placed and cured. Supplemental techniques and recommendations as cited in the literature may include using bonding agents; using various forms of mechanical enamel preparation, such as air abrasion and modification with a bur (enameloplasty); and using the four-handed application technique.
Bonding agents, also known as adhesives, may be used when applying pit-and-fissure sealants. Current bonding systems are marketed as total-and self-etch systems. The total-etch systems involve a three- or two-step placement technique, with a separate step for acid etching. The self-etch systems are packaged either as self-etching primers with separate adhesives or all-in-one systems that combine acid etchants, primers and adhesives. Both systems are available in single or multiple bottles.25
Clinical questions regarding pit-and-fissure sealants.
Although the scientific evidence supports the use of pit-and-fissure sealants as an effective caries-preventive measure, clinical questions remain about the indications for placing pit-and-fissure sealants, criteria for their placement over early (noncavitated) caries and techniques to optimize retention and caries prevention. To address these topics, the expert panel considered the following clinical questions:
- – Under what circumstances should sealants be placed to prevent caries?
- – Does placing sealants over early (noncavitated) lesions prevent progression of the lesions?
- – Are there conditions that favor the placement of resin-based versus glass ionomer cement sealants in terms of retention or caries prevention?
- – Are there any techniques that could improve sealants retention and effectiveness in caries prevention?
These clinical recommendations do not address the cost-effectiveness of using pit-and-fissure sealants. However, multiple models have shown that basing selection criteria for sealant placement on caries risk is cost-effective.26,27 Readers are referred to resources cited in the reference list for further discussion of cost-effectiveness.26–33
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METHODS
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In this report, we provide an abbreviated description of the review method we used. The full methods, including the complete search strategy, are provided as Appendix 1 in supplemental data to the online version of this article (visit "http://jada.ada.org").
The ADA Council on Scientific Affairs convened a panel of experts to evaluate the systematic reviews and clinical trials identified by staff of the ADA Center for Evidence-based Dentistry (CEBD). The council selected panelists on the basis of their expertise in the relevant subject matter. The expert panel convened at a workshop held at the ADA Headquarters in Chicago Nov. 13-15, 2006, to evaluate the collective evidence and develop evidence-based clinical recommendations for use of pit-and-fissure sealants.
CEBD staff members searched MEDLINE to identify systematic reviews that addressed the four clinical questions.2,5,34–42 They conducted a second search to identify clinical studies published since the identified systematic reviews were conducted.17,33,43–78
Members of the expert panel (B.G. and W.K.) presented an unpublished manuscript that examined individual studies included in three recent systematic reviews regarding sealant effectiveness.2,5,79 (That manuscript now has been published.80) CDC completed a multivariate analysis of factors associated with sealant retention, including use of the two-handed method versus the four-handed method. The included studies evaluated the retention of second- or third-generation resin-based sealant materials and provided data on whether the sealant was applied with the two-handed or the four-handed method.80
For each identified systematic review and clinical study, the panel determined the final exclusion of publications. They excluded publications on the basis of the following criteria: they did not directly address one of the identified clinical questions; the sealant materials they described were not available in the United States; and the panelists had concerns about the methodology described. Appendix 2 in the supplemental data online is a list of excluded publications.
For each included publication, the panel developed an evidence statement and graded it according to a system modified from that of Shekelle and colleagues81 (Table 1
). The panel developed clinical recommendations that were based on the evidence statements. They classified clinical recommendations according to the strength of the evidence that forms the basis for the recommendation, again using a system modified from that of Shekelle and colleagues81 (Table 2
). It is important to note that while the classification of the recommendation may not directly reflect the importance of the recommendation, it does reflect the quality of scientific evidence that supports the recommendation. Because the effectiveness of sealants depends on clinical retention,5,11,12 the panelists chose to accept clinical sealant retention as a reasonable proxy for caries prevention.