NIH: Consensus Development Conference on Diagnosis and Management of Dental Caries Throughout Life: Background

Jane A. Weintraub, D.D.S., M.P.H.:

In 1983 the National Institutes of Health hosted a consensus development conference on dental sealants in the prevention of tooth decay (NIH, 1984). The panel�s conclusion was that the "placement of sealants is a highly effective means of preventing pit and fissure caries." The panel said that sealants were 100 percent effective in pits and fissures that remained completely sealed, although sealant retention declines over time. Since then, there have been comprehensive reviews (Weintraub, 1989; Ripa, 1985, 1993) and a meta-analysis (Llodra, Bravo, Delgado-Rodriguez, et al., 1993) that confirmed the effectiveness of sealants and a workshop that developed guidelines for their use (Siegal, Kumar, 1995). Sealants are still needed, since 78 percent of 17-year-olds in the United States have experienced dental caries (Surgeon General, 2000), and most of the disease occurs in pits and fissures (Kaste, Selwitz, Oldakowski, et al., 1996). Sealants, however, are far from being universally applied. In 1988-94, only 23 percent of U.S. 8-year-old children and 15 percent of 14-year-old children had received sealants (U.S. DHHS, Healthy People 2010). The current charge is to examine the evidence demonstrating the effectiveness of sealants in high risk children and to discuss the findings of the Research Triangle Institute/University of North Carolina group.

The RTI/UNC group used four initial criteria to select caries management studies: (1) studies of methods applied or prescribed in a professional setting (or professional provision); (2) in vivo studies; (3) studies with a concurrent comparison group; and (4) studies using traditional outcome measures of caries experience. For studies of the management of noncavitated lesions they included studies where the lesion was the unit of analysis. For studies on the management of caries in high-risk individuals, the risk determination was "made on an individual subject level based on carious lesion experience and/or bacteriologic testing." In other words, high-risk status conferred by group membership, such as a school or community with a high caries rate or low socioeconomic status, was not sufficient.

Because of these restrictive criteria, the investigators found only one study (Heller, 1995) that met the criteria and examined sealant use in noncavitated lesions, and only two studies that met the criteria and used sealants alone (Sheykholeslam, Houpt, 1978) or sealants in combination with other preventive agents in high-risk individuals (Zickert, Emilson, Krasse, 1982). Another sealant study was listed in the references but is not found in the tables (Carlsson, Petersson, Twetman, 1997).

This presentation will describe the RTI/UNC criteria, as well as those four studies and their limitations, in more detail. Additional studies are also discussed to better reflect the nature of sealant studies and include the studies that appear in this abstract�s tables 1 and 2.

Many of the first trials of sealants used a half-mouth design where children with one or two pairs of sound, homologous molars were included. Sealant was applied to one randomly selected molar while its pair was left unsealed. Most of those trials did not specifically discuss caries risk status, but review indicates that some of them specifically selected children with prior caries experience (Buonocore, 1970, 1971; Brooks, Mertz-Fairhurst, Della-Giustina, et al., 1976; Mertz-Fairhurst, Fairhurst, Williams, et al., 1984; Sheykholeslam, Houpt, 1978; Houpt, Shey, 1983; McCune, Bojannini, Abodeely, et al., 1979), either in general or specifically first permanent molars. In the latter case, studies such as those by Rock, Gordon, and Bradnock (1978) and Rock and Evans (1982) required all four first permanent molars to be erupted and caries-free in 6-7 and 8-year-olds, respectively. Thus, these children might have been at lower caries risk than children who did not have all four molars caries-free (McCune, Horowitz, Heifetz, et al., 1973; Weintraub, Stearns, Burt, et al., 1993.)

Other studies with a half-mouth design included children with one or two pairs of sound, homologous, first permanent molars. The proportion of children contributing only one pair may be indicative of at least one member of the other pair being unerupted or (more likely) carious, depending on the age of the child. The proportions of pairs of caries-free teeth available may have been a surrogate measure of the child�s caries status, indirectly correlated with caries experience and caries risk. These studies likely included a mix of low- and high-risk children. The current effectiveness of sealants is underestimated because the first generation of material used, polymerized by ultraviolet light, was less effective than newer materials and is no longer in use (Ripa, 1993). The retention rate in any sealant trial is also dependent on the accuracy with which examiners can identify the presence of sealant. Misclassification occurs more often when a clear resin rather than an opaque resin is used (Rock, Potts, Marchment, et al., 1989).

Caries risk can be considered at the personal level or at the tooth level. Some studies have compared sealants on carious vs. noncarious teeth (Leverett, Brenner, Handelman, et al., 1983), or on sound surfaces vs. surfaces with incipient lesions (Heller, Reed, Bruner, et al., 1995). In 1991, Handelman reviewed radiographic and bacteriologic studies investigating the therapeutic use of sealants and concluded that "caries is inhibited and may in fact regress under intact sealants." Some (Weerheijm, Groenn, Bast, et al., 1992) have expressed concern about occlusal radiolucencies beneath sealed surfaces. In retrospective sealant studies, dentists may or may not have selected high-risk children for sealant placement, but sealed and unsealed teeth can be compared in children, based on their prior caries experience as a measure of their caries risk status (Weintraub, Stearns, Rozier, et al., In press.) Recent attempts to target high-risk children have compared sealant survival rates (Kumar, Cavila, Green, et al., 1997), caries reduction (Carlsson, Petersson, Twetman, et al., 1997), or reduction of S. mutans levels (Mass, Eli, Lev-Dor-Samovici, et al., 1999) in teeth sealed in high-risk children compared to unsealed or sealed teeth in low-risk children.

Table 1. Pit and fissure sealants in high risk children: half-mouth study design

First Author	Year	Type of Sealant	N at Start	Age at start	Caries Risk Determination	Follow-up Years	Full Retention (at final exam)	Effectiveness (at final exam) %
Buonocore	1970 1971	UV-light	60	4-15 (mean 9)	Caries-free individuals with well coalesced occlusal surfaces excluded	2	87%	99%–permanent teeth 87%–primary teeth
McCune Horowitz	1973 1976, 1977	UV-light Nuva-Seal	128 301 429	K, 1st, 6th, 7th Total	Sealant placed on paired and unpaired teeth (usually homologue had already decayed)	5	42% (50%, 26% in paired and unpaired teeth after 4 years)	30%–younger group 38%–older group 98% where sealant completely present 50% unpaired sealed teeth dev caries 26% of paired sealed teeth, 41% paired control teeth
Brooks Mertz-Fairhurst	1976 1984	Nuva-Seal Delton	385	6-8	Caries-free children excluded (about 48% of those screened) 79% of possible first perm molar pairs treated	7	31%–NuvaSeal, 66% Delton	12% NuvaSeal, 55% Delton (10% of completely sealed teeth became carious-combined data from both sealant types)
Houpt	1978, 1983	Delton	205	6-10 (mean 7.5)	Evidence of caries and a pair of caries-free homologous first perm molars (21% screened were eligible)	6	58%	56%
Charbeneau	1977, 1979	Kerr, Chem-cured	143	5-8	81% of possible first perm molar pairs included	4	52.4%	53.4%
McCune	1979	Delton	200	6-8	At least one carious tooth	3	87%	85%
Thylstrup	1976, 1978	Concise Chem.-polymer.	217	7	40% one first perm molar pair, 60% two pairs	2	60%	98%–full 50%–partial 10%–lost
Richardson Gibson	1980, 1982	Chem-cure, pink colored	266	2nd grade	80% of eligible molars, teeth sealed if sound or "sticky"	5	67.4%	51.2%
Vrbirc	1983, 1986	Contact Seal	244	6.8	76% of possible first perm molar pairs	5	52%	55%

Table 2.Pit and fissure sealants in high risk children: other study designs

First Author	Date	Study Design	Control/ Comparison	Type of Sealant	N at Start	Age at Start	Follow-Up Years	Caries Risk Determination	Outcome	Conclusions
Leverett	1983	Half-mouth, benefit/cost analysis	Sealants on one side, restorative care on other	Nuva-Seal	292	6-9	4	Caries-active (sealants placed on a carious surface) Caries-inactive (sealant placed on sound surface)	1 year retention–52%, resealed; After 4 years, sealed surfaces 74% less caries increment than unsealed	Benefit cost ratios based on time or costs were more favorable for caries-active. Sealants should not be used unless evidence of past or current caries experience
Weintraub	1993	Retrospective cohort, patient records, Life table analysis, cost-effectiveness	Children with none, any or 4 molars sealants; children with and without prior restorations	Varied	275	7.4	5.8–mean (up to 11 years)	Restorations on first molars prior to sealant placement on remaining molars	8-year survival: sealed teeth with and without prior restorations–85%, 94%; unsealed teeth–23% and 46%	Cost savings from sealants were obtained within 4-6 years for children with prior restorations; after 8 years without prior restorations
Heller	1995	Retrospective cohort study, patient health center records	96 children with and 17 without sealants, sealed and unsealed teeth	Delton	113	1st grade	5	Tooth surfaces rated sound, "incipient", or frank caries	Decay rates for initially sound sealed and non-sealed surfaces were 0.81 and 0.125 (OR=1.63); for initially incipient surfaces, .108 and .518 (OR=8.88)	Initially sound teeth were unlikely to become carious in 5 years; sealants more effective in preventing further caries on surfaces initially with incipient lesions
Kumar	1997	Survival analysis	Sealed high- risk first molars (65% sites) compared to unsealed low-risk first molars (35% sites)	Helioseal, Delton	1,122	7-9	4	Eligibility required prior caries experience. Teeth with shallow anatomy, occlusal or proximal D or F excluded	Retention (with some resealing)–65-82%; Time to restoration or caries similar for both groups. Cumulative survival rate for 4 years: .89-.94	Targeting approach was effective

Table 2. Pit and fissure sealants in high risk children: other study designs (continued)

First Author	Date	Study Design	Control/ Comparison	Type of Sealant	N at Start	Age at Start	Follow-Up Years	Caries Risk Determination	Outcome	Conclusions
Carlsson	1997	Prospective study, tx based on caries risk assessment, radiographs used	High-risk children (121) received sealant, low risk did not (83)	Helioseal-F (fluoride)	204	6-7	2	Risk based on salivary mutans streptococci, lactobacilli, buffer capacity, past caries experience, cariogenic diet	76.6% complete sealant retention, First molar DFS and dfs incidence lower for sealed group, but NS, enamel caries incidence sig diff in both dentitions	Two-year caries incidence was 11-70% lower in high risk sealed group (range based on dentition and outcome measure)
Maas	1998	Prospective study of two groups receiving sealants; sealant delayed 3 months on one side	Group 1 — mean deft =2.40 (low risk), Group 2 — mean deft = 6.60 (high risk)	Helioseal	52	6-8	0.5	Initially, deft "microbial replica" measured occlusal S. mutans	For both groups, S. mutans was significantly reduced immediately after sealing and lasted up to six months	Sealants reduced bacterial levels for both low-and high-risk groups
Weintraub	In press	Retrospective cohort, Medicaid claims, discrete time hazard model	Sealed and unsealed teeth	Dentists’ choice	15,438	4-7	8	Low risk --no prior Caries-Related Service involving Occlusal surface (CRSO) Middle risk— 1 prior CRSO, High risk > 2 prior CRSO	Unsealed molars 3x more likely to get CRSO than sealed molars. Low risk —sealants effective up to 4 years, middle risk — lower odds for 6 years; high risk — reductions up to 7 years	Medicaid expenditure savings for high-risk children within 2 years; not for low risk.

Conclusions

1. Sealants are very effective if completely retained on the tooth surface.
2. Most sealant studies have included low-risk children (all four first molars caries-free), high-risk children (prior caries experience), or a mixture of both low- and high-risk children. However, analyses may not have been stratified by caries risk status. Sealants have been effective to varying degrees in all of these studies.
3. There is evidence that sealants are more effective in preventing further caries and providing cost savings in a shorter time span if placed in individuals (or teeth) with high caries risk compared to individuals with low caries risk.
4. Most caries risk assessment methods used in these studies relied on past caries experience or presence of incipient lesions. Caries risk assessment methods are needed to predict high risk prior to clinical caries development so that sealants can be used to prevent caries on all susceptible teeth.

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Abstracts Index