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A comparative study of two pit and fissure sealants: two-year results in Augusta, Ga
ARTICLES
A
c o m
p a r a t i v e
t w
o - y e a r
s t u d y
r e s u lt s
in
o f
t w o
A u g u s t a ,
p it
a n d
fis s u r e
G a
J a ck D. B r o o k s , DDS, MS E va J. M e rtz -F a ir h u r s t, DDS V ic t o r E. D e lla -G iu s tin a , DDS, M PH Jam es E. W illia m s , DDS, D r PH C a rl W . F a irh u rst, PhD
Two pit and fissure sealants, an autopolym erized unfilled resin, and an ultraviolet-light-curing unfilled resin, applied to the perm anent first molars o f children are com pared in terms o f retention and efficacy.
\ A / i t h i n a ten-year period, pit and fissure sealants have progressed from the stage of clinical trial to the commercial availability of seven products. Two of these products, Nuva-Seal* and Deltont are clas sified as “acceptable” and three are classified as “provisionally accepta ble” by the American Dental Associ ation’s Council on Dental Materials and Devices. The remaining two products have not yet received either classification. R eview o f the literature
Current sealants are based on the reaction product of the bisphenol-A and glycidyl methacrylate (BISGMA) system which is cured either by ultraviolet light (UV) or a chemi cal catalyst. Earlier clinical studies1'5 focused on the UV-lightcuring system, that is, Nuva-Seal. Recent clinical studies7'9 are now focusing on the use of autopoly merized BIS-GMA systems. The autopolymerized system may offer advantages over the UV-lightcuring system in reduced cost and ease of application. These advan tages, however, are secondary in importance to the retention of the 722 ■ JADA, Vol. 98, May 1979
s e a la n t s :
sealant and inhibition of dental caries. Therefore, it is important first to determine the retentive and caries-inhibiting properties of both systems. Should the autopoly merized system prove to be similar in retention and inhibition of caries then selection of a sealant could be based on other factors, such as cost and ease of application.
Horowitz and others3reported the results of the two-year evaluation of Nuva-Seal at Kalispell, Mont. In that study, the permanent first molars presented the most stringent test for retention of sealant in 5- to 8-yearold children. Retention of sealant in maxillary and mandibular perma nent first molars was 41% and 57%, respectively. Horowitz and others found that retention of sealant de creased in teeth situated more poste riorly. This trend was recently ver ified by Bailey and others.10
Besides representing the most stringent test for retention of sealant, the permanent first molars may be considered relevant models for studies of sealants because loss of these teeth at a young age leads to many dental problems in later years. The purpose of this study was to compare the retention and efficacy
on permanent first molars of Delton, an autopolymerized pit and fissure sealant, and Nuva-Seal, a UV-lightcuring sealant. A previous report compared the results of one year’s data on retention for both sealants.7 This paper describes the retention and the caries-protective effects two years after a single application of either Delton or Nuva-Seal pit and fissure sealants to the teeth of chil dren living in Augusta, Ga. M aterials and m ethods
Because descriptions of the criteria for subject selection, the socio economic status of the study popula tion, sealant application procedures, and evaluation methods have been previously reported,7 only a sum mary is presented here. Signed parental consent forms were obtained before the children were screened. Children up to 8 years of age with either one or two pairs of contralateral sound perma nent first molars were admitted to the study. An indication of other past or current carious activity was also required. Children with cariesfree mouths were excluded because caries was not likely to develop in their teeth; this would contribute to the efficacy results. On the basis of previous studies,3,10 only the permanent first molars were selected for study. In addition to serving as a stringest test for retention of sealant, the use of permanent first molars provided a simplified study design for data analysis, reduced chances of errors in application and recording, and permitted simpler and faster follow-up evaluations. A randomized assignment sheet determined which sealant was to be used for each child and on which side of the mouth the teeth were to be treated. The teeth on the untreated side served as the controls. This pro-
ARTICLES
cedure is know n as the half-mouth experimental design. The sealant was applied by six dentists during a seven-day period. Each dentist applied each sealant on alternate days. Cotton rolls were used for isolation, and an air syringe was used for drying during applica tion o f sealant. Dentists were trained in the use o f both sealants on extrac ted teeth, before they applied them clinically. A clin ician experienced in the application o f both sealants observed these prestudy applica tions. The children w ere independently examined after 6 ,1 2 , and 24 months by the tw o dentists w h o performed the baseline examinations. N ew data forms were used at each exam in ation to record the presence or ab sence o f the sealant and the DMF surface index in the control and treated teeth. Disagreements were im m ediately recon ciled by a co m bin ed reexamination and by reach ing a consensus before dism issing the child. R e s u lts T w o years after placem ent o f the sealant, 311 o f the original children (81%) were exam ined. A s show n in Table 1, 233 pairs o f teeth in 152 children treated with Delton and 258 pairs o f teeth in 159 children treated w ith Nuva-Seal w ere examined for retention o f sealant and DMF surface index. Eighty percent o f the teeth originally sealed with Delton and 85% o f those sealed with Nuva-Seal were available for the two-year reex amination. Data on retention o f seal ant are show n in Table 2. Complete retention for Delton was 84% in com parison with 58% for Nuva-Seal. The difference betw een these tw o groups o f treated teeth in regard to the proportion o f teeth having com plete retention versus partial or com plete loss o f sealant was signifi cant (P<.001, using a chi-square test). Separating the data for m axil lary and mandibular teeth show ed that the difference for com plete re tention betw een these teeth was not statistically significant at the 5% level for either sealant.
Table 1 ■ Results in 311 children examined two years after
application of sealant to permanent first molars. P a irs o f teeth Sealant
C h ild re n
M a x illa r y
M a n d ib u la r
T o ta l
152 159 311
113 128 241
120 130 250
233 258 491
D e lto n N uva-S eal T o ta l
Table 2 ■ Retention of sealant in permanent first molars after two years. D e lto n M a x illa r y and m a n d ib u la r
N uva -S e a l
M a x illa r y
M a x illa r y and m a n d ib u la r
M a n d ib u la r
M a x illa r y
M a n d ib u la r
R eten tio n
N o.
%
No.
%
N o.
%
N o.
%
N o.
%
N o.
%
C om plete P a rtia l N one T o ta ls
196 24 13 233
84.1 10.3 5.6 100.0
92 14 7 113
81.4 12.4 6.2 100.0
104 10 6 120
86.7 8.3 5.0 100.0
150 62 46 258
58.1 24.0 17.8 100.0
68 36 24 128
53.1 28.1 18.8 100.0
82 26 22 130
63.1 20.0 16.9 100.0
Table 3 ■ Number of teeth losing sealant by occlusal
location. D e lto n M a x illa r y L o c a tio n M esia l th ird C en tra l th ir d D is ta l th ir d
N uva-S eal
M a n d ib u la r
M a x illa r y
M a n d ib u la r
N o.
%
No.
%
No.
%
No.
%
11
10
7
6
32
25
28
22
9
8
11
9
35
27
36
28
18
16
12
10
52
41
39
30
The most stringent test for reten tion o f sealant was the distal third of the occlusal surface o f maxillary m o lars. Table 3 shows that loss o f both Delton and Nuva-Seal sealants on the distal third was greater than that on other locations. The effect o f treatment for each sealant was inferred by classifying the treatment in each ch ild experi encing occlusal caries activity in the treated and control paired teeth as either a success, failure, or tie (Table 4). Treatments were classified as a success if the in ciden ce o f occlusal caries was greater on the control teeth than on the treated teeth; a failure if the caries in ciden ce was greater on the treated teeth; and a tie if caries or no caries were fou n d for both treated and control teeth. If caries were fou n d on both treated and control teeth, such a situation w ou ld constitute a clin ical failure; how ever, such an outcom e has n o ef fect on the statistics o f this experi mental design. The num ber o f ties was equally divided betw een the classifications o f success and failure;
in this way, all carious teeth were accounted for in the statistical test. A binom ial test was used to test the hypothesis that no difference existed betw een the proportion o f successes and failures in each sealant group. This hypothesis was rejected at the 1% level for each sealant and im plied the presence o f an effect of treatment. Table 5 show s that the teeth w h ich were sealed with either sealant had less occlu sal caries than the un sealed controls. Eleven percent o f the teeth treated with Delton were d e cayed or filled on the occlusal sur faces in com parison with 37% o f the untreated controls. Twenty percent o f the teeth treated with Nuva-Seal were decayed or filled on the o c clu sal surface in com parison with 32% o f the untreated controls. D ecay was never observed beneath either o f the tw o sealants w hen they were intact. It should also be n oticed that 52% of the 25 carious, Delton-treated teeth were recorded as having been re stored with amalgam, as were 41% o f the 86 carious control teeth. For
Brooks-others:COMPARISON OF TWO SEALANTS: TWO-YEAR RESULTS ■ 723
ARTIC LES
Table 4 ■ Classification of occlusal caries status of treatedcontrol pairs of teeth after 24 months. D elto n N o. o f c h ild re n w it h fe w e r decayed surfaces on tre a te d side (successes) N o. o f c h ild re n w it h fe w e r decayed surfaces on c o n tro l side (failures) N o. o f c h ild re n w it h decayed surfaces on b o th sides (ties) B in o m ia l p r o b a b ility (tw o -ta ile d ) N o. o f c h ild re n w it h n o decayed su r faces (ties) N o. o f c h ild re n
Table 5 ■ Occlusal decay or restoration two years after
sealant was applied to permanent first molars.
N uva-S eal
54
42
4
15
14 P C C .O O l
D ecayed teeth
D ecayed teeth restored
teeth
N o.
%
N o.
%*
233 233
25 86
10.7 36.9
13 35
52.0 40.7
258 258
51 82
19.8 31.8
25 33
49.0 40.2
D e lto n Treated Decayed N uva-S eal T reated C o n tro l
27 0.0064 75 159
80 152
Nn o f
‘ P ercent restored o f those decayed .
Table 6 ■ Occlusal status of treated-control pairs of teeth at the two-year
examination. B oth teeth sound
B oth teeth decayed
Tre a te d -sou n d c o n tro l-d e caye d
63 81 144
14 8 22
34 30 64
68 88 156
19 12 31
34 17 51
D elto n M a x illa ry M a n d ib u la r T o ta l N uva-Seal M a x illa ry M a n d ib u la r T o ta l
Treated-decayed co n tro l-s o u n d
N et gain
Percent effectiveness
2 1 3
32 29 61
66.7% 76.3% 70.9%
7 13 20
27 4* 31
50.9% 13.8% 37.8%
*Not statistically significant.
the Nuva-Seal group, 49% o f the 51 carious treated teeth were seen as having been restored, as were 40% o f the 82 carious controls. The decision to restore the treated and control teeth of the children in the study was made by persons other than the investigators. How ever, it is appar ent that the percent o f treated and control decayed teeth that were re stored was about the same in both groups. It is assumed that the incidence o f caries on contralaterally paired m o lars is similar, and a significant d if ference in carious activity between the treated and control teeth in each pair w ill give information on effi cacy o f the sealant in preventing o c clusal caries. The net gain is a meas ure o f the num ber o f teeth saved from occlu sal caries by application o f sealant. In Table 6, this statistic is fou n d by subtracting the number o f sealant failures from the number o f sealant successes. A sealant success occu rs w hen the treated tooth re mains sound and the control tooth becom es carious. A sealant failure occurs w hen the treated tooth b e com es carious and the control tooth remains sound. The net gain for Delton was 61 teeth; the net gain for Nuva-Seal was 31 teeth. The percent effectiveness is a relative measure o f the number o f
724 ■ JADA, Vol. 98, May 1979
teeth saved (net gain) com pared with the num ber o f untreated teeth that becam e carious. It is obtained by dividin g the net gain by the total car ious control teeth. The percent effec tiveness for Delton was 70.9%; for Nuva-Seal, it was 37.8%. Delton was equally effective on both maxillary and mandibular permanent first m o lars; Nuva-Seal was apparently more effective on maxillary molars. D is c u s s io n A com parison o f the retention data for permanent first molars from this study in Augusta with the retention data for permanent first molars from the K alispell study3 and the Alachua, Fla, study5 is show n in Table 7. T he table show s that the com plete molar retention in the A u gusta study is slightly higher for Nuva-Seal than in the Kalispell study and almost the same as in the Alachua study. The Kalispell co m parison is noteworthy because the design o f the study and analysis o f data are similar to the Augusta study. However, the retention data in the Kalispell study were based on children aged 7 to 10 years and 12 to 16 years at the time o f the two-year examination. The Augusta children were 8 to 10 years old at this same examination interval.
Data on the clinical effectiveness o f Delton for tw o or more years are lim ited because o f the newness of the product. However, a study by Bojanini and others8 reported a 76% rate o f com plete retention in 21 permanent first molars after three years. These results are comparable to the 84% retention rate found for Delton after tw o years in this study. Similar com parisons o f the effi cacy data on permanent first molars from the Augusta study with those o f the Kalispell and A lachua studies are show n in Table 8. In the Alachua study, the percent effectiveness for Nuva-Seal was similar for both the maxillary and mandibular molars. In the Kalispell and Augusta Nuva-Seal results, the percent effectiveness for maxillary molars was greater than for the mandibular molars in each study. In the Augusta study, h o w ever, the percent effectiveness for the mandibular molars was con sid erably low er than comparable data from the Kalispell and Alachua studies. A lso to be considered relative to the three studies is the status o f water fluoridation in the com munities. T he water supplies of Kalispell and Alachua are not fluoridated but Augusta has been fluoridating its water since 1956. At this poin t in the anticipated four-
ARTICLES
Table 7 ■ Complete retention of sealant in permanent first molars. Study Nuva-Seal Kalispell, Mont Maxillary Mandibular Alachua, Fla Maxillary Mandibular Augusta, Ga Maxillary Mandibular Delton Augusta, Ga Maxillary Mandibular
Total
No.
Table 8 years.
Efficacy in permanent first molars after two
Percent Study
108 81
44 46
40.7 56.8
42 44
21 29
50.0 65.9
128 130
68 82
53.1 63.1
113 120
92 104
81.4 86.7
year study, no unusual differences can be attributed to this variable. The percent effectiveness for Del ton of 77% in B ojanini’s three-year study is slightly higher than the 71% fou n d in this study after tw o years. However, as previously noted, Boja n in i’s study was based on too few molars to be firm ly conclusive. No other studies o f Delton were avail able for com parison. Examination o f the relative rates o f retention o f the tw o sealants in Table 2 and the occlu sal DMFS dif ferences o f the tw o sealants in Table 5 further supports the direct rela tionship betw een com plete retention o f sealant and prevention o f occlusal caries. Both Nuva-Seal and Delton were equally effective in these teeth where each sealant was com pletely retained. For future studies on sealants, it is recom m ended that n ew form ula tions be com pared to established products. M oreover, the study should include retention, net gain, and percent effectiveness, by tooth types within the categories o f per manent and decidu ou s teeth to allow for more accurate interstudy comparisons. S u m m a ry a n d c o n c lu s io n s A total o f 311 children w ere exam ined tw o years after placem ent o f sealant. One-hundred fifty two ch il dren were treated w ith Delton on 233 permanent first molars and 159 children were treated with NuvaSeal on 258 permanent first molars. The proportion o f sealed teeth com pletely retaining all sealant after
No. of study pairs
Effectiveness %
74 65
72.1 61.8
42 44
63.0 58.3
68 88
50.9 13.8
63 81
66.7 76.3
Nuva-Seal Kalispell, Mont Maxillary Mandibular Alachua, Fla Maxillary Mandibular Augusta, Ga Maxillary Mandibular Delton Augusta, Ga Maxillary Mandibular
tw o years was 84% for the Delton group and 58% for the Nuva-Seal group. A strong positive treatment effect was show n for both sealants at a high level o f statistical con fiden ce (P c.O l). The UV-light-curing BIS-GMA resin was 38% effective in prevent ing occlusal caries on 258 perma nent first molars o f children tw o years after application. The autopolym erized BIS-GMA resin was 71% effective in prevent ing occlusal caries on 233 perma nent first molars o f children tw o years after application It can be con clu d ed that: — The permanent first molar is a relevant and practical m odel for studies o f sealants. — Both sealants have a treatment effect in preventing occlusal caries on permanent first molars o f ch il dren tw o years after application. — A s a result o f its higher co m plete retention, Delton was som e what m ore effective in preventing occlusal caries than was Nuva-Seal.
are a t th e S ch o o l o f D e n tis try , M e d ic a l C ollege o f G eorgia. D r. M e rtz -F a irh u rs t is an N IH p o s t d o c to ra l research fe llo w , d e p a rtm e n t o f o ra l b io lo g y , d e p a rtm e n t o f c o m m u n ity d e n tis try . D r. D e lla -G iu s tin a is a n associate p rofessor, d e p a rtm e n t o f c o m m u n ity d e n tis try , a n d th e d is tr ic t d e n ta l d ire c to r o f East C e n tra l G eorgia H e a lth D is tric t. D r. W illia m s is a p rofe ssor and c o o rd in a to r o f th e d e p a rtm e n t o f c o m m u n ity d e n tis try . D r. F a irh u rs t is a p rofe ssor a n d c o o r d in a to r o f d e n ta l m a te ria ls , d e p a rtm e n t o f re s to ra tiv e d e n tis try . Send requests fo r re p rin ts to D r. F a irh u rs t, D e p a rtm e n t o f R estorative D e n tis try , S c h o o l o f D e n tis try , M e d ic a l C ollege o f G eorgia, A u g u s ta , 30902. 1. B u o n o co re , M .G . C aries p re v e n tio n i n p its a n d fissu res sealed w it h an adh e sive re s in p o ly m e riz e d b y u ltr a v io le t lig h t: a tw o -y e a r s tu d y o f a s in g le adh e sive a p p lic a tio n . JA D A 82(5):1090-1093, 1971. 2. R ock, W .P . F issu re sealants. F u rth e r re s u lts o f c lin ic a l tria ls . B r D e n t J 136(8):317-321, 1974. 3. H o ro w itz ,
H .S .;
H e ife tz ,
S.B.;
and
M cC u n e , R.J. T h e effe ctive n ess o f an adh e sive sealant i n p re v e n tin g o c c lu s a l caries: fin d in g s a fte r tw o years in K a lis p e ll, M o n ta n a . J A D A 8 9(4):885-890, 1974. 4. G o u rle y , J.M . A tw o -y e a r s tu d y o f a fis sure sealant in tw o N o v a S co tia c o m m u n itie s . J P ub H e a lth D e n t 35(2):132-137, 1975. 5. G o in g , R.E., a n d others. T w o -y e a r c lin ic a l e v a lu a tio n o f a p it a n d fis s u re sealant. R eten t io n a n d loss o f substance. J A D A 92(2):388396, 1976. 6. G o in g , R.E., a n d others. T w o -y e a r c lin ic a l
‘ Nuva-Seal, L. D. Caulk Co., Milford, Del 19963. tD e lto n , Johnson a n d Johnson D e n ta l P ro d u cts Co., East W in d s o r, NJ 08520.
The informed consent of parents or legal guardians of all children who participated in the experimental investigation reported in the manuscript was obtained, after the nature of the procedures and possible discomforts and risks had been fully explained. Dr. Brooks is currently at the Regional Dental Center, University of Iowa, Iowa City. He was formerly an assistant professor, department of community dentistry, School of Dentistry, Medical College of Georgia. The other authors
e v a lu a tio n o f a p it a nd fis s u re sealant. C aries in itia tio n a n d p ro g re s s io n . J A D A 92(3):578585, 1976. 7. B ro oks, J.D., and others. A c o m p a ra tiv e s tu d y o f th e re te n tio n o f tw o p it and fis s u re sealants: O n e -ye ar re s u lts . J P rev D e n t 3(5):434 6, 1976. 8. B o ja n in i, J., and oth e rs. E ffective n e ss o f p it a n d fis s u re sealants in th e p re v e n tio n o f caries. J P re v D e n t 3 (6 ):3 1 -3 4 ,1976. 9. C harbeneau, G .T.; D e n n is o n , J.B.; and R yge, G. A f ille d p it and fis s u re sealant: 18m o n th re s u lts . J A D A 95(2):299-306, 1977. 10. B a ile y , L ., a n d oth e rs. D iffe re n tia l seal a n t re te n tio n b y to o th ty p e in a c lin ic a l tria l: te n -m o n th re s u lts . J D e n t Res 56:B70 a bstract n o. 74, 1977.
Brooks-others : COMPARISON OF TWO SEALANTS: TWO-YEAR RESULTS ■ 725
A
c o m
p a r a t i v e
t w
o - y e a r
s t u d y
r e s u lt s
in
o f
t w o
A u g u s t a ,
p it
a n d
fis s u r e
G a
J a ck D. B r o o k s , DDS, MS E va J. M e rtz -F a ir h u r s t, DDS V ic t o r E. D e lla -G iu s tin a , DDS, M PH Jam es E. W illia m s , DDS, D r PH C a rl W . F a irh u rst, PhD
Two pit and fissure sealants, an autopolym erized unfilled resin, and an ultraviolet-light-curing unfilled resin, applied to the perm anent first molars o f children are com pared in terms o f retention and efficacy.
\ A / i t h i n a ten-year period, pit and fissure sealants have progressed from the stage of clinical trial to the commercial availability of seven products. Two of these products, Nuva-Seal* and Deltont are clas sified as “acceptable” and three are classified as “provisionally accepta ble” by the American Dental Associ ation’s Council on Dental Materials and Devices. The remaining two products have not yet received either classification. R eview o f the literature
Current sealants are based on the reaction product of the bisphenol-A and glycidyl methacrylate (BISGMA) system which is cured either by ultraviolet light (UV) or a chemi cal catalyst. Earlier clinical studies1'5 focused on the UV-lightcuring system, that is, Nuva-Seal. Recent clinical studies7'9 are now focusing on the use of autopoly merized BIS-GMA systems. The autopolymerized system may offer advantages over the UV-lightcuring system in reduced cost and ease of application. These advan tages, however, are secondary in importance to the retention of the 722 ■ JADA, Vol. 98, May 1979
s e a la n t s :
sealant and inhibition of dental caries. Therefore, it is important first to determine the retentive and caries-inhibiting properties of both systems. Should the autopoly merized system prove to be similar in retention and inhibition of caries then selection of a sealant could be based on other factors, such as cost and ease of application.
Horowitz and others3reported the results of the two-year evaluation of Nuva-Seal at Kalispell, Mont. In that study, the permanent first molars presented the most stringent test for retention of sealant in 5- to 8-yearold children. Retention of sealant in maxillary and mandibular perma nent first molars was 41% and 57%, respectively. Horowitz and others found that retention of sealant de creased in teeth situated more poste riorly. This trend was recently ver ified by Bailey and others.10
Besides representing the most stringent test for retention of sealant, the permanent first molars may be considered relevant models for studies of sealants because loss of these teeth at a young age leads to many dental problems in later years. The purpose of this study was to compare the retention and efficacy
on permanent first molars of Delton, an autopolymerized pit and fissure sealant, and Nuva-Seal, a UV-lightcuring sealant. A previous report compared the results of one year’s data on retention for both sealants.7 This paper describes the retention and the caries-protective effects two years after a single application of either Delton or Nuva-Seal pit and fissure sealants to the teeth of chil dren living in Augusta, Ga. M aterials and m ethods
Because descriptions of the criteria for subject selection, the socio economic status of the study popula tion, sealant application procedures, and evaluation methods have been previously reported,7 only a sum mary is presented here. Signed parental consent forms were obtained before the children were screened. Children up to 8 years of age with either one or two pairs of contralateral sound perma nent first molars were admitted to the study. An indication of other past or current carious activity was also required. Children with cariesfree mouths were excluded because caries was not likely to develop in their teeth; this would contribute to the efficacy results. On the basis of previous studies,3,10 only the permanent first molars were selected for study. In addition to serving as a stringest test for retention of sealant, the use of permanent first molars provided a simplified study design for data analysis, reduced chances of errors in application and recording, and permitted simpler and faster follow-up evaluations. A randomized assignment sheet determined which sealant was to be used for each child and on which side of the mouth the teeth were to be treated. The teeth on the untreated side served as the controls. This pro-
ARTICLES
cedure is know n as the half-mouth experimental design. The sealant was applied by six dentists during a seven-day period. Each dentist applied each sealant on alternate days. Cotton rolls were used for isolation, and an air syringe was used for drying during applica tion o f sealant. Dentists were trained in the use o f both sealants on extrac ted teeth, before they applied them clinically. A clin ician experienced in the application o f both sealants observed these prestudy applica tions. The children w ere independently examined after 6 ,1 2 , and 24 months by the tw o dentists w h o performed the baseline examinations. N ew data forms were used at each exam in ation to record the presence or ab sence o f the sealant and the DMF surface index in the control and treated teeth. Disagreements were im m ediately recon ciled by a co m bin ed reexamination and by reach ing a consensus before dism issing the child. R e s u lts T w o years after placem ent o f the sealant, 311 o f the original children (81%) were exam ined. A s show n in Table 1, 233 pairs o f teeth in 152 children treated with Delton and 258 pairs o f teeth in 159 children treated w ith Nuva-Seal w ere examined for retention o f sealant and DMF surface index. Eighty percent o f the teeth originally sealed with Delton and 85% o f those sealed with Nuva-Seal were available for the two-year reex amination. Data on retention o f seal ant are show n in Table 2. Complete retention for Delton was 84% in com parison with 58% for Nuva-Seal. The difference betw een these tw o groups o f treated teeth in regard to the proportion o f teeth having com plete retention versus partial or com plete loss o f sealant was signifi cant (P<.001, using a chi-square test). Separating the data for m axil lary and mandibular teeth show ed that the difference for com plete re tention betw een these teeth was not statistically significant at the 5% level for either sealant.
Table 1 ■ Results in 311 children examined two years after
application of sealant to permanent first molars. P a irs o f teeth Sealant
C h ild re n
M a x illa r y
M a n d ib u la r
T o ta l
152 159 311
113 128 241
120 130 250
233 258 491
D e lto n N uva-S eal T o ta l
Table 2 ■ Retention of sealant in permanent first molars after two years. D e lto n M a x illa r y and m a n d ib u la r
N uva -S e a l
M a x illa r y
M a x illa r y and m a n d ib u la r
M a n d ib u la r
M a x illa r y
M a n d ib u la r
R eten tio n
N o.
%
No.
%
N o.
%
N o.
%
N o.
%
N o.
%
C om plete P a rtia l N one T o ta ls
196 24 13 233
84.1 10.3 5.6 100.0
92 14 7 113
81.4 12.4 6.2 100.0
104 10 6 120
86.7 8.3 5.0 100.0
150 62 46 258
58.1 24.0 17.8 100.0
68 36 24 128
53.1 28.1 18.8 100.0
82 26 22 130
63.1 20.0 16.9 100.0
Table 3 ■ Number of teeth losing sealant by occlusal
location. D e lto n M a x illa r y L o c a tio n M esia l th ird C en tra l th ir d D is ta l th ir d
N uva-S eal
M a n d ib u la r
M a x illa r y
M a n d ib u la r
N o.
%
No.
%
No.
%
No.
%
11
10
7
6
32
25
28
22
9
8
11
9
35
27
36
28
18
16
12
10
52
41
39
30
The most stringent test for reten tion o f sealant was the distal third of the occlusal surface o f maxillary m o lars. Table 3 shows that loss o f both Delton and Nuva-Seal sealants on the distal third was greater than that on other locations. The effect o f treatment for each sealant was inferred by classifying the treatment in each ch ild experi encing occlusal caries activity in the treated and control paired teeth as either a success, failure, or tie (Table 4). Treatments were classified as a success if the in ciden ce o f occlusal caries was greater on the control teeth than on the treated teeth; a failure if the caries in ciden ce was greater on the treated teeth; and a tie if caries or no caries were fou n d for both treated and control teeth. If caries were fou n d on both treated and control teeth, such a situation w ou ld constitute a clin ical failure; how ever, such an outcom e has n o ef fect on the statistics o f this experi mental design. The num ber o f ties was equally divided betw een the classifications o f success and failure;
in this way, all carious teeth were accounted for in the statistical test. A binom ial test was used to test the hypothesis that no difference existed betw een the proportion o f successes and failures in each sealant group. This hypothesis was rejected at the 1% level for each sealant and im plied the presence o f an effect of treatment. Table 5 show s that the teeth w h ich were sealed with either sealant had less occlu sal caries than the un sealed controls. Eleven percent o f the teeth treated with Delton were d e cayed or filled on the occlusal sur faces in com parison with 37% o f the untreated controls. Twenty percent o f the teeth treated with Nuva-Seal were decayed or filled on the o c clu sal surface in com parison with 32% o f the untreated controls. D ecay was never observed beneath either o f the tw o sealants w hen they were intact. It should also be n oticed that 52% of the 25 carious, Delton-treated teeth were recorded as having been re stored with amalgam, as were 41% o f the 86 carious control teeth. For
Brooks-others:COMPARISON OF TWO SEALANTS: TWO-YEAR RESULTS ■ 723
ARTIC LES
Table 4 ■ Classification of occlusal caries status of treatedcontrol pairs of teeth after 24 months. D elto n N o. o f c h ild re n w it h fe w e r decayed surfaces on tre a te d side (successes) N o. o f c h ild re n w it h fe w e r decayed surfaces on c o n tro l side (failures) N o. o f c h ild re n w it h decayed surfaces on b o th sides (ties) B in o m ia l p r o b a b ility (tw o -ta ile d ) N o. o f c h ild re n w it h n o decayed su r faces (ties) N o. o f c h ild re n
Table 5 ■ Occlusal decay or restoration two years after
sealant was applied to permanent first molars.
N uva-S eal
54
42
4
15
14 P C C .O O l
D ecayed teeth
D ecayed teeth restored
teeth
N o.
%
N o.
%*
233 233
25 86
10.7 36.9
13 35
52.0 40.7
258 258
51 82
19.8 31.8
25 33
49.0 40.2
D e lto n Treated Decayed N uva-S eal T reated C o n tro l
27 0.0064 75 159
80 152
Nn o f
‘ P ercent restored o f those decayed .
Table 6 ■ Occlusal status of treated-control pairs of teeth at the two-year
examination. B oth teeth sound
B oth teeth decayed
Tre a te d -sou n d c o n tro l-d e caye d
63 81 144
14 8 22
34 30 64
68 88 156
19 12 31
34 17 51
D elto n M a x illa ry M a n d ib u la r T o ta l N uva-Seal M a x illa ry M a n d ib u la r T o ta l
Treated-decayed co n tro l-s o u n d
N et gain
Percent effectiveness
2 1 3
32 29 61
66.7% 76.3% 70.9%
7 13 20
27 4* 31
50.9% 13.8% 37.8%
*Not statistically significant.
the Nuva-Seal group, 49% o f the 51 carious treated teeth were seen as having been restored, as were 40% o f the 82 carious controls. The decision to restore the treated and control teeth of the children in the study was made by persons other than the investigators. How ever, it is appar ent that the percent o f treated and control decayed teeth that were re stored was about the same in both groups. It is assumed that the incidence o f caries on contralaterally paired m o lars is similar, and a significant d if ference in carious activity between the treated and control teeth in each pair w ill give information on effi cacy o f the sealant in preventing o c clusal caries. The net gain is a meas ure o f the num ber o f teeth saved from occlu sal caries by application o f sealant. In Table 6, this statistic is fou n d by subtracting the number o f sealant failures from the number o f sealant successes. A sealant success occu rs w hen the treated tooth re mains sound and the control tooth becom es carious. A sealant failure occurs w hen the treated tooth b e com es carious and the control tooth remains sound. The net gain for Delton was 61 teeth; the net gain for Nuva-Seal was 31 teeth. The percent effectiveness is a relative measure o f the number o f
724 ■ JADA, Vol. 98, May 1979
teeth saved (net gain) com pared with the num ber o f untreated teeth that becam e carious. It is obtained by dividin g the net gain by the total car ious control teeth. The percent effec tiveness for Delton was 70.9%; for Nuva-Seal, it was 37.8%. Delton was equally effective on both maxillary and mandibular permanent first m o lars; Nuva-Seal was apparently more effective on maxillary molars. D is c u s s io n A com parison o f the retention data for permanent first molars from this study in Augusta with the retention data for permanent first molars from the K alispell study3 and the Alachua, Fla, study5 is show n in Table 7. T he table show s that the com plete molar retention in the A u gusta study is slightly higher for Nuva-Seal than in the Kalispell study and almost the same as in the Alachua study. The Kalispell co m parison is noteworthy because the design o f the study and analysis o f data are similar to the Augusta study. However, the retention data in the Kalispell study were based on children aged 7 to 10 years and 12 to 16 years at the time o f the two-year examination. The Augusta children were 8 to 10 years old at this same examination interval.
Data on the clinical effectiveness o f Delton for tw o or more years are lim ited because o f the newness of the product. However, a study by Bojanini and others8 reported a 76% rate o f com plete retention in 21 permanent first molars after three years. These results are comparable to the 84% retention rate found for Delton after tw o years in this study. Similar com parisons o f the effi cacy data on permanent first molars from the Augusta study with those o f the Kalispell and A lachua studies are show n in Table 8. In the Alachua study, the percent effectiveness for Nuva-Seal was similar for both the maxillary and mandibular molars. In the Kalispell and Augusta Nuva-Seal results, the percent effectiveness for maxillary molars was greater than for the mandibular molars in each study. In the Augusta study, h o w ever, the percent effectiveness for the mandibular molars was con sid erably low er than comparable data from the Kalispell and Alachua studies. A lso to be considered relative to the three studies is the status o f water fluoridation in the com munities. T he water supplies of Kalispell and Alachua are not fluoridated but Augusta has been fluoridating its water since 1956. At this poin t in the anticipated four-
ARTICLES
Table 7 ■ Complete retention of sealant in permanent first molars. Study Nuva-Seal Kalispell, Mont Maxillary Mandibular Alachua, Fla Maxillary Mandibular Augusta, Ga Maxillary Mandibular Delton Augusta, Ga Maxillary Mandibular
Total
No.
Table 8 years.
Efficacy in permanent first molars after two
Percent Study
108 81
44 46
40.7 56.8
42 44
21 29
50.0 65.9
128 130
68 82
53.1 63.1
113 120
92 104
81.4 86.7
year study, no unusual differences can be attributed to this variable. The percent effectiveness for Del ton of 77% in B ojanini’s three-year study is slightly higher than the 71% fou n d in this study after tw o years. However, as previously noted, Boja n in i’s study was based on too few molars to be firm ly conclusive. No other studies o f Delton were avail able for com parison. Examination o f the relative rates o f retention o f the tw o sealants in Table 2 and the occlu sal DMFS dif ferences o f the tw o sealants in Table 5 further supports the direct rela tionship betw een com plete retention o f sealant and prevention o f occlusal caries. Both Nuva-Seal and Delton were equally effective in these teeth where each sealant was com pletely retained. For future studies on sealants, it is recom m ended that n ew form ula tions be com pared to established products. M oreover, the study should include retention, net gain, and percent effectiveness, by tooth types within the categories o f per manent and decidu ou s teeth to allow for more accurate interstudy comparisons. S u m m a ry a n d c o n c lu s io n s A total o f 311 children w ere exam ined tw o years after placem ent o f sealant. One-hundred fifty two ch il dren were treated w ith Delton on 233 permanent first molars and 159 children were treated with NuvaSeal on 258 permanent first molars. The proportion o f sealed teeth com pletely retaining all sealant after
No. of study pairs
Effectiveness %
74 65
72.1 61.8
42 44
63.0 58.3
68 88
50.9 13.8
63 81
66.7 76.3
Nuva-Seal Kalispell, Mont Maxillary Mandibular Alachua, Fla Maxillary Mandibular Augusta, Ga Maxillary Mandibular Delton Augusta, Ga Maxillary Mandibular
tw o years was 84% for the Delton group and 58% for the Nuva-Seal group. A strong positive treatment effect was show n for both sealants at a high level o f statistical con fiden ce (P c.O l). The UV-light-curing BIS-GMA resin was 38% effective in prevent ing occlusal caries on 258 perma nent first molars o f children tw o years after application. The autopolym erized BIS-GMA resin was 71% effective in prevent ing occlusal caries on 233 perma nent first molars o f children tw o years after application It can be con clu d ed that: — The permanent first molar is a relevant and practical m odel for studies o f sealants. — Both sealants have a treatment effect in preventing occlusal caries on permanent first molars o f ch il dren tw o years after application. — A s a result o f its higher co m plete retention, Delton was som e what m ore effective in preventing occlusal caries than was Nuva-Seal.
are a t th e S ch o o l o f D e n tis try , M e d ic a l C ollege o f G eorgia. D r. M e rtz -F a irh u rs t is an N IH p o s t d o c to ra l research fe llo w , d e p a rtm e n t o f o ra l b io lo g y , d e p a rtm e n t o f c o m m u n ity d e n tis try . D r. D e lla -G iu s tin a is a n associate p rofessor, d e p a rtm e n t o f c o m m u n ity d e n tis try , a n d th e d is tr ic t d e n ta l d ire c to r o f East C e n tra l G eorgia H e a lth D is tric t. D r. W illia m s is a p rofe ssor and c o o rd in a to r o f th e d e p a rtm e n t o f c o m m u n ity d e n tis try . D r. F a irh u rs t is a p rofe ssor a n d c o o r d in a to r o f d e n ta l m a te ria ls , d e p a rtm e n t o f re s to ra tiv e d e n tis try . Send requests fo r re p rin ts to D r. F a irh u rs t, D e p a rtm e n t o f R estorative D e n tis try , S c h o o l o f D e n tis try , M e d ic a l C ollege o f G eorgia, A u g u s ta , 30902. 1. B u o n o co re , M .G . C aries p re v e n tio n i n p its a n d fissu res sealed w it h an adh e sive re s in p o ly m e riz e d b y u ltr a v io le t lig h t: a tw o -y e a r s tu d y o f a s in g le adh e sive a p p lic a tio n . JA D A 82(5):1090-1093, 1971. 2. R ock, W .P . F issu re sealants. F u rth e r re s u lts o f c lin ic a l tria ls . B r D e n t J 136(8):317-321, 1974. 3. H o ro w itz ,
H .S .;
H e ife tz ,
S.B.;
and
M cC u n e , R.J. T h e effe ctive n ess o f an adh e sive sealant i n p re v e n tin g o c c lu s a l caries: fin d in g s a fte r tw o years in K a lis p e ll, M o n ta n a . J A D A 8 9(4):885-890, 1974. 4. G o u rle y , J.M . A tw o -y e a r s tu d y o f a fis sure sealant in tw o N o v a S co tia c o m m u n itie s . J P ub H e a lth D e n t 35(2):132-137, 1975. 5. G o in g , R.E., a n d others. T w o -y e a r c lin ic a l e v a lu a tio n o f a p it a n d fis s u re sealant. R eten t io n a n d loss o f substance. J A D A 92(2):388396, 1976. 6. G o in g , R.E., a n d others. T w o -y e a r c lin ic a l
‘ Nuva-Seal, L. D. Caulk Co., Milford, Del 19963. tD e lto n , Johnson a n d Johnson D e n ta l P ro d u cts Co., East W in d s o r, NJ 08520.
The informed consent of parents or legal guardians of all children who participated in the experimental investigation reported in the manuscript was obtained, after the nature of the procedures and possible discomforts and risks had been fully explained. Dr. Brooks is currently at the Regional Dental Center, University of Iowa, Iowa City. He was formerly an assistant professor, department of community dentistry, School of Dentistry, Medical College of Georgia. The other authors
e v a lu a tio n o f a p it a nd fis s u re sealant. C aries in itia tio n a n d p ro g re s s io n . J A D A 92(3):578585, 1976. 7. B ro oks, J.D., and others. A c o m p a ra tiv e s tu d y o f th e re te n tio n o f tw o p it and fis s u re sealants: O n e -ye ar re s u lts . J P rev D e n t 3(5):434 6, 1976. 8. B o ja n in i, J., and oth e rs. E ffective n e ss o f p it a n d fis s u re sealants in th e p re v e n tio n o f caries. J P re v D e n t 3 (6 ):3 1 -3 4 ,1976. 9. C harbeneau, G .T.; D e n n is o n , J.B.; and R yge, G. A f ille d p it and fis s u re sealant: 18m o n th re s u lts . J A D A 95(2):299-306, 1977. 10. B a ile y , L ., a n d oth e rs. D iffe re n tia l seal a n t re te n tio n b y to o th ty p e in a c lin ic a l tria l: te n -m o n th re s u lts . J D e n t Res 56:B70 a bstract n o. 74, 1977.
Brooks-others : COMPARISON OF TWO SEALANTS: TWO-YEAR RESULTS ■ 725