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Effectiveness of a pit and fissure sealant in the prevention of caries: three-year clinical results
A BIS-GMA sealant was applied to perm anent first molars o f 200 children between the ages o f 6 and 8 years. Incidence of caries in all sealant-treated molars was 8%; in matching pairs o f untreated molars, the incidence was 53%.
E f fe c tiv e n e s s o f a p it a n d f is s u r e s e a la n t in th e p r e v e n t io n o f c a rie s : t h r e e -y e a r c lin ic a l re s u lts
R obert J. M cC une, DDS, M SD Jorge B ojan ini, DDS R obert A. A b o d eely , PhD
c
tudies on pit and fissure sealants indicate that the presence of sealant on occlusal surfaces of teeth prevents caries. However, to provide adequate pro tection, the sealant must be retained for a significant time. The literature indicates that retention of seal ant is dependent on several factors, including type of tooth (molars or premolars), method of applica tion, composition, and cure of sealant. Two systems of com m ercially available pit and fissure sealants have been extensively researched. One is a cold-cured BIS-GMA system and the other is a BIS-GMA system cured by ultraviolet light. B u on ocore,1 Going and others, 2-4 M cCune and others,5 and Horowitz and others6 reported on the retentive properties of BIS-GMA sealants cured by ultraviolet light; moderate to excellent retention was seen on different types of teeth. In contrast, Bag ramian and others7 used the same sealant system and reported less impressive retention, particularly on permanent molars. Retention of cold-cured BIS-GMA sealants has been rep orted as e x ce lle n t by several in v e sti gators.1,8' 12 In a pilot study of eight sealant form ula tions in eight groups of 25 children each, Bojanini and others8 reported that one formulation, later marketed as Delton* pit and fissure sealant, offered the best retention after 36 months. This report describes sealant retention after 24 and 36 months and presents data on caries preven tion from a larger study started in 1979; the study is designed to supplement the pilot study of 25 ch il dren by Bojanini and others.8
Methods A description of the clinical protocol and methods of study was reported earlier.8 A brief review of the basic principles of the study is presented here. Chil dren 6 to 8 years of age were selected random ly from pu blic sch ools in M ed ellin , C olom b ia, South America. Only children who had at least one pair of homologous permanent first molars free of caries were eligible to participate. In addition, the child had to have at least one carious tooth. The half mouth technique was used for placem ent of sealant with the contralateral tooth serving as a control. Evaluations were conducted at 6, 12, 24, and 36 months. Two dentists independently exam ined the children. Detection of caries and the absence or presence of sealant were determined by visual in spection with use of a mirror and explorer. Any dis agreement between the two examining dentists was resolved by a combined examination.
Results
Recall o f patients A total of 200 children were enrolled in the study. Table 1 shows the number of patients available for recall examination for each evaluation period and the number of initially sound pairs of teeth exam ined at each interval. The smallest number of re called patients were exam ined at 24 months when 158 patients (79% recall) were available for exam iJADA, Vol. 99, October 1979 ■ 619
Table
1
Table 3 ■ R e t e n t i o n o f s e a l a n t o n m a x i l l a r y a n d m a n d i b u l a r
■ R e c a ll e x a m i n a t i o n a n d n u m b e r o f i n i t i a l l y s o u n d ,
p a i r e d t e e t h e x a m i n e d c l i n i c a l l y u p to 36 m o n th s . R ecall
m o l a r s a t 12, 24, a n d 36 m o n th s . R eten tio n of sea la n t
No. p a ire d te e th
tion (m onths)
a v ailab le a t recall
B aseline 6 12 18 24 36
200 191 173 174 158 170
P a ire d teeth M ax illary (total) 318 304 275 277 252 272
No. p airs
M a n d ib u lar
180 171 155 157 143 155
E x a m in a tio n
138 133 120 120 109 117
te e th
12 m o n th s M ax illary m o lars M a n d ib u la r m o la rs T o tal 24 m o n th s M a x illary m o la rs M a n d ib u la r m o lars T o ta l 36 m o n th s M a x illary m o la rs M a n d ib u la r m o la rs T o tal
n ation. A total o f 252 pairs o f teeth w ere ex a m in ed at that tim e. A t 36 m on th s, 170 p atien ts (85% recall) w ith a total o f 272 pairs o f m olars w ere available for exam in ation . T h e rate o f recall is c o n sid ered e x c e l len t for th is ty p e o f stu d y.
155
C om plete %
No.
91.0 141
T he num ber o f teeth from w h ic h sea la n t w a s lo st at 36 m o n th s is g iv e n in T able 2. Three lo c a tio n s o f tooth surface are id en tified : reg io n 1, m e sia l pit; re g io n 2, central pit; reg io n 3, d istal pit. T h e data in d i cate that, o f th e 22 m axilla ry m olars from w h ic h sealan t w a s lo st at 36 m o n th s, sealan t w a s lo st at re g io n 3 for 13 m olars, w h erea s sea la n t w a s lo st at all three reg io n s for four m olars. In contrast, sealant w a s lo s t for o n ly 12 m a n d ib u la r m o la r s at 36 m on th s. O f th o se , sealan t w a s lo st for o n ly tw o at re g io n 3, w h erea s sea la n t w a s lo s t for se v e n at a ll three regio n s. T he differen ce in sea la n t lo s s in r eg io n 3 b e tw e e n m axilla ry and m an d ib ular m olars (13 v s tw o) m ay be ca u sed b y the fact that it is m ore d ifficu lt to keep th e d ista l lo c a tio n o f th e m axillary m olar dry during p la c e m e n t o f sealant.
C o m p r e h e n siv e data o n r e te n tio n o f se a la n t o n m axillary and m and ibu lar m olars at th e recall exam in a tio n s at 12, 24, and 36 m o n th s are p resen ted in T able 3. T he resu lts in d ic a te that co m p lete reten tion o f sealan t at 12, 24, and 36 m o n th s w as 91.6% , 88.9% , and 87.5% , resp ectiv ely . T here w a s n o sig n ifica n t d ifferen ce in co m p lete reten tion o f sealant b e tw e e n m a x illa ry and m an dib ular m olars at any exam in ation .
%
No.
6.5
10
2.6
4
120
92.5 111
5.0
6
275
91.6 252
5.8
16
143
88.1
126
8.4
12
109
89.9
98
5.5
6
252
88.9 224
7.1
18
4.0
10
155
85.8 133 11.fi
18
2,fi
4
117
89.7 105
4.3
5
272
87.5 238
8.5
23
2.5 3{P > .05f) 2.5
7
3.5
5
4.6 5 (P > .0 5 f)
6.0 7 (P > .0 5 f) 4.0
11
R e te n tio n o f s e a la n t v s i n c id e n c e o f c a r ie s T h e relation sh ip b etw e en degree o f sealan t reten tio n (com p lete, partial, or n o retention) and o c c lu sa l caries at 24 and 36 m on th s is sh o w n in Table 4. T he data for co m p lete reten tio n sh o w that, w ith o n e e x
Table 2 ■ N u m b e r o f t e e t h t h a t lo s t s e a l a n t ( 3 6 - m o n th e v a l u a tio n ) .* No. teeth P a ire d teeth (total)
M ax illary
M a n d ib u lar
2 3 15 3 11 34
1 2 13 2 4 22
1 1 2 1 7 12
‘Descriptions of regions 1, 2, and 3 are found in study by Bojanini and others8: region 1 indicates mesial pit; region 2 indicates central pit; region 3 indicates distal pit. 6 2 0 ■ J A D A , V o l. 9 9 , O c to b e r 1 9 7 9
No.
T h e resu lts for partial reten tion o f sealant at 12, 24, and 36 m on th s w ere 5.8% , 7.1%, and 8.5% , re sp e c tiv e ly . T h e in crease in partial reten tion at 36 m o n th s is n o t sta tistic a lly sig n ific a n t. T he data su g g e st that m axillary m olars at each recall ex a m i n a tio n h ave greater partial reten tion o f sealan t than m andibular m olars. T h u s, at 36 m on th s, the sealan t w a s partially retain ed o n 18 m axillary m olars but o n ly o n fiv e m andibular m olars. In sp ite o f th ese n u m erical d ifferen ces, there is in su ffic ie n t sta tisti cal ev id e n c e to d eterm in e w h eth er m axillary and m andibular m olars sh o w different characteristics o f partial sealant retention. Data for total lo ss o f sealan t at 12, 24, and 36 m on th s are a lso g iv e n in T able 3. Total lo ss w a s a p p ro xim ately 2.5% at 12 m on th s and 4.0% for b oth 24 an d 36 m on th s. T h is in d ic a tes n o sig n ifica n t total lo s s o f sealant, ev e n at 36 m on th s.
R e te n tio n o f s e a la n t
T o o th su rfa c e
T o ta l loss
%
‘Partial retention is defined to mean that sealant is present on one or two (but not all three) of the occlusal regions 1, 2, or 3 shown in Illustration. fA nonparametric test described by Bross13was done to test whether classifica tion in maxillary and mandibular molars and the classification in the three levels of sealant retention was independent. No evidence was found to reject the hypothesis of independency (P > .05).
L o ss o f s e a la n t
Loss on reg io n 1 only Loss o n reg io n 2 only Loss o n reg io n 3 only Loss o n reg io n 1 a n d 2 C o m p lete loss o n reg io n 1, 2, an d 3 T o ta l a c c u m u la te d loss
P artial*
T a b le 4
■ Retention of sealant vs incidence of caries at 24 and 36 months. Retention o f sealant Com plete
Total loss
Partial
Exam ination
Occlusal caries status
Treated
Control
Treated
Control
Treated
Control
24 m onths
Sound teeth Carious teeth Sound teeth Carious teeth
224 0 237 1
146 78 116 122
18 0 13 10
6 12 9 14
3 7 0 11
7 3 3 8
36 m onths
ce p tio n , th e teeth treated w ith sea la n t d id n o t b e co m e carious. T he data a lso in d ica te that, at 24 m o n th s, no o c c lu sa l caries w a s n o tic e d in a n y o f th e 18 teeth on w h ic h sea la n t w a s p artially retain ed. In contrast, at 24 m on th s, 12 con trol teeth had o c c lu sa l caries. H ow ever, at 36 m o n th s, ten teeth o n w h ic h sealant w a s partially retain ed becam e carious as d id 14 c o n trol teeth . T h e d ifferen ce in rate o f caries o n teeth on w h ic h th e sea la n t w a s partially retain ed v s control teeth is sta tistic a lly sig n ifica n t at 24 b u t n ot at 36 m on th s. T h u s, it w o u ld appear that partial reten tion o f sealan t p ro v id ed sig n ific a n t p ro tectio n again st caries u p to 24 m on th s. T he in c id e n c e o f caries in teeth w ith co m p lete lo ss o f sealan t at 24 and 36 m o n th s is a lso presented. A t 24 m o n th s, se v e n sealant-treated a n d three c o n trol teeth h ad b eco m e carious. T h is d ifferen ce is n ot sta tistica lly sig n ifica n t.
d e n ce o f caries in sealant-treated teeth and in u n treated con trol teeth w a s com pared (Illustration). From six to 36 m on th s, th e p ercen t o f untreated (control) teeth that b ecam e carious in creased from ap p roxim ately 23% to 53%. In contrast, in sealanttreated teeth , th e in crease in caries from six to 36 m on th s w a s from 1% to 8%. T hus, th e difference in th e in c id e n c e o f caries b e tw e en sealant-treated and untreated teeth at six m on th s w as 22% and at 36 m o n th s, 45% . T h is difference in d ic a tes that sealant treatm ent p ro v id ed sig n ific a n t p ro tectio n o f the treated teeth again st caries for th is p eriod. In th e Illu stra tio n , an in v e r se r e la tio n sh ip is sh o w n b e tw e e n reten tion and in creased in c id e n c e o f caries. T h u s, a 10% red u ctio n in reten tion o f se a l ant, from 97.4% at six m on th s to 87.5% at 36 m on th s, is a cco m p a n ied b y a 7% in crease in th e rate of caries. H ow ever, b ecau se o f th e lo w rate o f caries, th e rela tio n sh ip can n ot be c o n sid ered sta tistic a lly sig n ifi cant.
C o m p le te r e te n tio n o f s e a la n t a n d i n c id e n c e o f c a r ie s
E f fi c a c y o f s e a la n t
T o d eterm in e further th e rela tio n sh ip b e tw e e n re ten tio n o f sea la n t and red u ctio n in caries, th e in c i
To d eterm in e the efficacy o f sealan t o n teeth at 24 and 36 m on th s, net gain and p ercen t e ffectiv en ess
Months Percent ofretention on treated teeth is shown by solid line; percent of caries on control teeth is shown by dashed line; percent of caries on sealant-treated teeth is shown by dotted line. M c C u n e -B o ja n in i-A b o d e e ly : E F F E C T IV E N E S S O F P I T A N D F IS S U R E S E A L A N T ■ 6 2 1
Table 5 ■ C o m p a r i s o n o f o c c l u s a l c a r i e s o f t r e a t e d a n d c o n t r o l te e t h ; n e t g a i n a n d p e r c e n t e f f e c tiv e n e s s ; e v a l u a t i o n a t 24 a n d 36 m o n th s . O c clu sa l c aries statu s E x a m in a tio n 24 m o n th s M ax illary M an d ib u lar T o tal 36 m o n th s M ax illary M an d ib u lar T o tal
T o tal no. o f p airs
C o n tro l te e th C ario u s
S ound
T rea te d teeth C arious
Sound
N et gain*
P e rc e n t effe c tiv e n ess!
143 109 252
45 48 93
98 61 159
3 4 7
140 105 245
42 44 86
93.3 91.792.5
155 117 272
71 73 144
84 44 128
11 11 22
144 106 250
60 62 122
84.5 84.9 84.7
*Net gain means carious control teeth minus carious treated teeth. fPercent effectiveness means net gain divided by carious control teeth multiplied by 100.
w ere d eterm in ed. T he n e t gain is an estim ate o f h o w m an y teeth w ere sav ed b eca u se o f a p p lica tio n of sealant. It is d eterm in ed b y subtracting th e num ber o f treated carious teeth from th e num ber o f control carious teeth . T able 5 sh o w s that th e n et g ain w a s 86 teeth sa v ed at 24 m o n th s and 122 teeth saved at 36 m on th s. T hu s, at 24 and 36 m on th s, resp ectiv ely , the n et gain w a s 34% and 45% o f th e sealant-treated teeth , that is, 34 and 45 teeth per 100 treated teeth esca p ed caries b eca u se o f a p p lica tio n o f sealant. T able 5 also in d ica tes that there is n o sig n ific a n t d if ference in n et gain b e tw e e n m axillary and m an d ib u lar m olars. T he percen t e ffe c tiv en ess is d efin ed as n et g ain d iv id e d by the num ber o f control carious teeth , m u ltip lie d by 100. T able 5 sh o w s percent ef fec tiv e n e ss v a lu e s o f 92.5% at 24 m o n th s and 84.7% at 36 m on th s.
Discussion T he resu lts o f th is stu d y in d ica te that co m p lete re ten tio n o f sealan t w as 88.9% an d 87.5% after 24 and 36 m on th s, resp ectiv ely . In a series o f stu d ies by Brooks and o th ers9-11 in A u gu sta, Ga, a cold -cu red p it an d fissu re sealant* w a s com p ared w ith sealan t cured w ith u ltra violet lig h t.t T he ch ild ren w ere ran d om ly se le c te d to re c e iv e eith er o f th e sealan ts on perm an en t first m olars on on e sid e o f the m outh. T he h o m o g o lo u s m olars o n the other sid e served as the control teeth. C om p lete reten tion w a s fo u n d in 84% of th e 233 teeth treated w ith co ld -cu red p it and fissu re sealan t at 24 m on th s com p ared w ith 58% of th e teeth treated w ith th e se a la n t cu r e d w ith u ltr a v io le t lig h t. A t 36 m on th s, the co ld -cu red sealan t w a s c o m p le te ly re tain ed in 80% o f th e 201 teeth ex a m in ed , w h ereas 60% w a s retained for th e other sealant. T h ese le v e ls o f co m p lete reten tion , as reported by Brooks and oth ers,9-11 are c o n siste n t w ith le v e ls fo u n d in the current study. M any c lin ic a l stu d ie s w ith other sealan ts h a ve in c lu d e d different ty p es o f teeth, often w ith a large proportion o f prem olars. G oing and oth ers3 c o n d u cted a stu d y in w h ic h 86 pairs o f perm an en t first 6 2 2 ■ J A D A , V o l. 9 9 , O c to b e r 1 9 7 9
m olars w ere exam in ed at 24 m on th s. A p p roxim ately 23% o f th e m olars treated w ith u ltraviolet ligh tcured sealan t had o c clu sa l caries, as com pared w ith ap p roxim ately 59% o f the controls. T h is d ifferen ce resu lted in an estim ated n e t ga in of 36%, or 31 teeth, and a p ercen t e ffec tiv en ess o f about 61%. In c o n trast, th e 24-m on th resu lts o f th e current stu d y in d i cate that o n ly se v e n (or ap p roxim ately 3%) o f the 252 cold -cu red , sealant-treated first m olars and 93 (or about 3 7%) o f th e con trol teeth w ere carious. T h is d ifference resu lts in an estim ated n et gain o f 86 teeth (34%) 'and a p ercen t effec tiv en ess o f ap p roxim ately 93%, after 24 m on th s. B rooks and oth ers9-11 com pared the effica cy o f the tw o sealan ts u n d er sim ilar c o n d itio n s. T he resu lts after 24 m on th s in d ica te th e n e t ga in o f th e ultra v io le t ligh t-cu red sealan t w a s 31 teeth sa ved from caries (258 treated) and 38% e ffectiv en ess. In c o n trast, at 24 m on th s, the n et gain o f the co ld -cu red p it and fissu re sealant w a s 61 teeth w ith o u t caries (233 treated) and 71% e ffectiv en ess. A t 36 m o n th s, th e re su lts from the stu d y by Brooks and others in d ica ted a n et gain o f 31 teeth sa v ed and 39% e ffec tiv en ess (205 treated) w ith the u ltraviolet ligh t-cu red system . A n et gain o f 59 teeth and 69% e ffec tiv en ess for the cold -cu red p it and fissu re sealan t (201 treated) w a s fou n d at 36 m on th s. T he resu lts p resen ted in th is re port and th o se o f Brooks and oth ers9-11 in d ica te that the cold -cu red p it and fissu re sealan t is h ig h ly effec tiv e in p reven tin g caries for 36 m on th s.
Summary W ith u se o f the h alf-m ou th tech n iq u e, a p it and fis sure sealan t w as a p p lied to the perm anent first m o lars of 200 ch ild ren b e tw e e n 6 and 8 years o f age in a co m m u n ity w ith flu o rid a ted w ater in C olom bia, S ou th A m erica. C om plete reten tion o f sealan t at 12, 24, and 36 m on th s after a p p lica tio n w a s 91.6% , 88.9% , and 87.5% , resp ectiv ely . Partial reten tion of sealan t w a s 5.8%, 7.1%, an d 8.5% at th e sam e inter vals. T he in c id e n c e o f caries in all sealant-treated teeth at 36 m on th s w a s 8% v s 53% in untreated paired teeth. O f th e 238 teeth that c o m p le te ly r e
tain ed sealant, o n ly o n e to o th h ad o c c lu sa l caries at 36 m on th s. N o sta tistic a lly sig n ific a n t d ifferen ce in co m p le te r eten tio n b e tw e e n m a x illa ry an d m a n dibular m olars w a s n o tic e d at a n y exam in ation . T he stu d y con firm s that th is co ld -cu red p it and fissu re sealan t is effectiv e in p rotectin g the o c c lu sa l surfaces o f teeth aga in st caries for at lea st three years.
*D elton, Jo h n so n & Jo h n so n , E ast W in d so r, NJ. tN u v a -S e a l, L. D. C au lk Co., M ilfo rd , Del. Dr. M cC une is v ic e -p re sid e n t, re s e a rc h a n d d e v e lo p m e n t, Jo h n so n & Jo h n so n D en tal P ro d u c ts C o; Dr. B o ja n in i is d ire c to r o f d e n ta l s ec tio n , S ec re ta ry of H e a lth a n d S o c ia l W elfare, M u n ic ip a lity o f M e d e llin , C olom bia, S o u th A m erica; a n d Dr. A b o d e e ly is d ire c to r o f re g u la to ry a ffairs a n d q u a l ity a ssu ra n c e , J o h n so n & Jo h n so n D e n tal P ro d u c ts Co. A d d re ss re q u e sts for re p rin ts to Dr. M cC une, J o h n so n & Jo h n so n D e n tal P ro d u c ts Co., 20 Lake Dr, E ast W in d so r, NJ 08520. 1. B uo n o co re, M .G. C aries p re v e n tio n in p its a n d fissu re s se a le d w ith a n a d h e s iv e re s in p o ly m e riz e d b y u ltra v io le t lig h t: a tw o -y ear s tu d y o f a s in g le a d h e s iv e a p p lic a tio n . JADA 8 2 (5 ):1 0 9 0 -1 0 9 3 ,1971. 2. G oing,R .E., a n d o th e rs. T w o -y ea 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 sea la n t. R e ten tio n a n d lo ss o f s u b sta n c e. JADA 9 2 (2 ):3 8 8 -3 9 6 ,1976.
3. G oing, R.E., a n d o th e rs. T w o -y ea r c lin ic a l e v a lu a tio n of a p it a n d fis s u re s ea la n t. C aries in itia tio n a n d p ro g re ssio n . JADA 9 2{3):578-585,1976. 4. G oing, R.E., a n d o th e rs. F o u r-y e ar c lin ic a l e v a lu a tio n o f a p it a n d fis s u re se a la n t. JADA 95(5):972-981, 1977. 5. M cC une, R.J., a n d o th e rs. P it a n d fissu re sea la n ts: o n e -y e ar re su lts fro m a s tu d y in K a lisp e ll, M o n tan a. JADA 8 7 (5 ):1 1 7 7 -1 1 8 0 ,1973. 6. H o ro w itz , H .S.; H eifetz, S.B.; a n d M cC une, R.J. T h e e ffectiv en ess of a n a d h e s iv e s e a la n t in p re v e n tin g o c clu sa l caries. F in d in g s a fter tw o years in K a lisp e ll, M o n tan a . JADA 8 9 (4 ):8 8 5 -8 9 0 ,1977. 7. B ag ra m ia n , R.A .; G raves, R .C.; a n d S riv asta v a , S. S e a la n t e ffe c tiv e n e ss fo r c h ild re n re c e iv in g a c o m b in a tio n of p re v e n tiv e m e th o d s in a flu o rid a te d c o m m u n ity : tw o -y e a r re su lts. J D en t R es 56(12):1511-1519, 1977. 8. B o ja n in i, J.D., a n d o th e rs. E ffectiveness of p it a n d fissu re se a la n ts in th e p re v e n tio n o f c aries. J P rev D e n t 3 (6 ):3 1 -3 4 ,1976. 9. B rooks, J.D., a n d o th e rs. R e ten tio n a n d efficacy o f tw o p it a n d fissu re s ea la n ts. IADR A b stra cts, no. 7 0 2 ,1 9 7 6 . 10. B rooks, J.D., a n d o th e rs. T w o -y ea r c lin ic a l e v a lu a tio n of th e re te n tio n a n d efficacy o f tw o p it a n d fissu re sea la n ts. IADR A b stra cts, no. 73, B 7 0 ,1977. 11. B rooks, J.D., a n d o th e rs. T h ree -y e a r c lin ic a l e v a lu a tio n o f th e re te n tio n a n d efficacy o f tw o p it a n d fissu re sea la n ts. IADR A b stracts, no. 1140, A 359, 1978. 12. H o u p t, M ., a n d S h e y k h o le slam , Z . T h e c lin ic a l effe c tiv e n ess o f Delto n fissu re s e a la n t a fte r e le v en m o n th s. IADR A b stra cts, no. 799, B 251, 1977. 13. B ross, J. Is th e re a n in c re a se d ris k ? F e d P ro c 1 3 :8 1 5 ,1 9 5 4 .
M c C u n e -B o ja n im -A b o d e e ly : E F F E C T IV E N E S S O F P I T A N D F IS S U R E S E A L A N T ■ 6 2 3
E f fe c tiv e n e s s o f a p it a n d f is s u r e s e a la n t in th e p r e v e n t io n o f c a rie s : t h r e e -y e a r c lin ic a l re s u lts
R obert J. M cC une, DDS, M SD Jorge B ojan ini, DDS R obert A. A b o d eely , PhD
c
tudies on pit and fissure sealants indicate that the presence of sealant on occlusal surfaces of teeth prevents caries. However, to provide adequate pro tection, the sealant must be retained for a significant time. The literature indicates that retention of seal ant is dependent on several factors, including type of tooth (molars or premolars), method of applica tion, composition, and cure of sealant. Two systems of com m ercially available pit and fissure sealants have been extensively researched. One is a cold-cured BIS-GMA system and the other is a BIS-GMA system cured by ultraviolet light. B u on ocore,1 Going and others, 2-4 M cCune and others,5 and Horowitz and others6 reported on the retentive properties of BIS-GMA sealants cured by ultraviolet light; moderate to excellent retention was seen on different types of teeth. In contrast, Bag ramian and others7 used the same sealant system and reported less impressive retention, particularly on permanent molars. Retention of cold-cured BIS-GMA sealants has been rep orted as e x ce lle n t by several in v e sti gators.1,8' 12 In a pilot study of eight sealant form ula tions in eight groups of 25 children each, Bojanini and others8 reported that one formulation, later marketed as Delton* pit and fissure sealant, offered the best retention after 36 months. This report describes sealant retention after 24 and 36 months and presents data on caries preven tion from a larger study started in 1979; the study is designed to supplement the pilot study of 25 ch il dren by Bojanini and others.8
Methods A description of the clinical protocol and methods of study was reported earlier.8 A brief review of the basic principles of the study is presented here. Chil dren 6 to 8 years of age were selected random ly from pu blic sch ools in M ed ellin , C olom b ia, South America. Only children who had at least one pair of homologous permanent first molars free of caries were eligible to participate. In addition, the child had to have at least one carious tooth. The half mouth technique was used for placem ent of sealant with the contralateral tooth serving as a control. Evaluations were conducted at 6, 12, 24, and 36 months. Two dentists independently exam ined the children. Detection of caries and the absence or presence of sealant were determined by visual in spection with use of a mirror and explorer. Any dis agreement between the two examining dentists was resolved by a combined examination.
Results
Recall o f patients A total of 200 children were enrolled in the study. Table 1 shows the number of patients available for recall examination for each evaluation period and the number of initially sound pairs of teeth exam ined at each interval. The smallest number of re called patients were exam ined at 24 months when 158 patients (79% recall) were available for exam iJADA, Vol. 99, October 1979 ■ 619
Table
1
Table 3 ■ R e t e n t i o n o f s e a l a n t o n m a x i l l a r y a n d m a n d i b u l a r
■ R e c a ll e x a m i n a t i o n a n d n u m b e r o f i n i t i a l l y s o u n d ,
p a i r e d t e e t h e x a m i n e d c l i n i c a l l y u p to 36 m o n th s . R ecall
m o l a r s a t 12, 24, a n d 36 m o n th s . R eten tio n of sea la n t
No. p a ire d te e th
tion (m onths)
a v ailab le a t recall
B aseline 6 12 18 24 36
200 191 173 174 158 170
P a ire d teeth M ax illary (total) 318 304 275 277 252 272
No. p airs
M a n d ib u lar
180 171 155 157 143 155
E x a m in a tio n
138 133 120 120 109 117
te e th
12 m o n th s M ax illary m o lars M a n d ib u la r m o la rs T o tal 24 m o n th s M a x illary m o la rs M a n d ib u la r m o lars T o ta l 36 m o n th s M a x illary m o la rs M a n d ib u la r m o la rs T o tal
n ation. A total o f 252 pairs o f teeth w ere ex a m in ed at that tim e. A t 36 m on th s, 170 p atien ts (85% recall) w ith a total o f 272 pairs o f m olars w ere available for exam in ation . T h e rate o f recall is c o n sid ered e x c e l len t for th is ty p e o f stu d y.
155
C om plete %
No.
91.0 141
T he num ber o f teeth from w h ic h sea la n t w a s lo st at 36 m o n th s is g iv e n in T able 2. Three lo c a tio n s o f tooth surface are id en tified : reg io n 1, m e sia l pit; re g io n 2, central pit; reg io n 3, d istal pit. T h e data in d i cate that, o f th e 22 m axilla ry m olars from w h ic h sealan t w a s lo st at 36 m o n th s, sealan t w a s lo st at re g io n 3 for 13 m olars, w h erea s sea la n t w a s lo st at all three reg io n s for four m olars. In contrast, sealant w a s lo s t for o n ly 12 m a n d ib u la r m o la r s at 36 m on th s. O f th o se , sealan t w a s lo st for o n ly tw o at re g io n 3, w h erea s sea la n t w a s lo s t for se v e n at a ll three regio n s. T he differen ce in sea la n t lo s s in r eg io n 3 b e tw e e n m axilla ry and m an d ib ular m olars (13 v s tw o) m ay be ca u sed b y the fact that it is m ore d ifficu lt to keep th e d ista l lo c a tio n o f th e m axillary m olar dry during p la c e m e n t o f sealant.
C o m p r e h e n siv e data o n r e te n tio n o f se a la n t o n m axillary and m and ibu lar m olars at th e recall exam in a tio n s at 12, 24, and 36 m o n th s are p resen ted in T able 3. T he resu lts in d ic a te that co m p lete reten tion o f sealan t at 12, 24, and 36 m o n th s w as 91.6% , 88.9% , and 87.5% , resp ectiv ely . T here w a s n o sig n ifica n t d ifferen ce in co m p lete reten tion o f sealant b e tw e e n m a x illa ry and m an dib ular m olars at any exam in ation .
%
No.
6.5
10
2.6
4
120
92.5 111
5.0
6
275
91.6 252
5.8
16
143
88.1
126
8.4
12
109
89.9
98
5.5
6
252
88.9 224
7.1
18
4.0
10
155
85.8 133 11.fi
18
2,fi
4
117
89.7 105
4.3
5
272
87.5 238
8.5
23
2.5 3{P > .05f) 2.5
7
3.5
5
4.6 5 (P > .0 5 f)
6.0 7 (P > .0 5 f) 4.0
11
R e te n tio n o f s e a la n t v s i n c id e n c e o f c a r ie s T h e relation sh ip b etw e en degree o f sealan t reten tio n (com p lete, partial, or n o retention) and o c c lu sa l caries at 24 and 36 m on th s is sh o w n in Table 4. T he data for co m p lete reten tio n sh o w that, w ith o n e e x
Table 2 ■ N u m b e r o f t e e t h t h a t lo s t s e a l a n t ( 3 6 - m o n th e v a l u a tio n ) .* No. teeth P a ire d teeth (total)
M ax illary
M a n d ib u lar
2 3 15 3 11 34
1 2 13 2 4 22
1 1 2 1 7 12
‘Descriptions of regions 1, 2, and 3 are found in study by Bojanini and others8: region 1 indicates mesial pit; region 2 indicates central pit; region 3 indicates distal pit. 6 2 0 ■ J A D A , V o l. 9 9 , O c to b e r 1 9 7 9
No.
T h e resu lts for partial reten tion o f sealant at 12, 24, and 36 m on th s w ere 5.8% , 7.1%, and 8.5% , re sp e c tiv e ly . T h e in crease in partial reten tion at 36 m o n th s is n o t sta tistic a lly sig n ific a n t. T he data su g g e st that m axillary m olars at each recall ex a m i n a tio n h ave greater partial reten tion o f sealan t than m andibular m olars. T h u s, at 36 m on th s, the sealan t w a s partially retain ed o n 18 m axillary m olars but o n ly o n fiv e m andibular m olars. In sp ite o f th ese n u m erical d ifferen ces, there is in su ffic ie n t sta tisti cal ev id e n c e to d eterm in e w h eth er m axillary and m andibular m olars sh o w different characteristics o f partial sealant retention. Data for total lo ss o f sealan t at 12, 24, and 36 m on th s are a lso g iv e n in T able 3. Total lo ss w a s a p p ro xim ately 2.5% at 12 m on th s and 4.0% for b oth 24 an d 36 m on th s. T h is in d ic a tes n o sig n ifica n t total lo s s o f sealant, ev e n at 36 m on th s.
R e te n tio n o f s e a la n t
T o o th su rfa c e
T o ta l loss
%
‘Partial retention is defined to mean that sealant is present on one or two (but not all three) of the occlusal regions 1, 2, or 3 shown in Illustration. fA nonparametric test described by Bross13was done to test whether classifica tion in maxillary and mandibular molars and the classification in the three levels of sealant retention was independent. No evidence was found to reject the hypothesis of independency (P > .05).
L o ss o f s e a la n t
Loss on reg io n 1 only Loss o n reg io n 2 only Loss o n reg io n 3 only Loss o n reg io n 1 a n d 2 C o m p lete loss o n reg io n 1, 2, an d 3 T o ta l a c c u m u la te d loss
P artial*
T a b le 4
■ Retention of sealant vs incidence of caries at 24 and 36 months. Retention o f sealant Com plete
Total loss
Partial
Exam ination
Occlusal caries status
Treated
Control
Treated
Control
Treated
Control
24 m onths
Sound teeth Carious teeth Sound teeth Carious teeth
224 0 237 1
146 78 116 122
18 0 13 10
6 12 9 14
3 7 0 11
7 3 3 8
36 m onths
ce p tio n , th e teeth treated w ith sea la n t d id n o t b e co m e carious. T he data a lso in d ica te that, at 24 m o n th s, no o c c lu sa l caries w a s n o tic e d in a n y o f th e 18 teeth on w h ic h sea la n t w a s p artially retain ed. In contrast, at 24 m on th s, 12 con trol teeth had o c c lu sa l caries. H ow ever, at 36 m o n th s, ten teeth o n w h ic h sealant w a s partially retain ed becam e carious as d id 14 c o n trol teeth . T h e d ifferen ce in rate o f caries o n teeth on w h ic h th e sea la n t w a s partially retain ed v s control teeth is sta tistic a lly sig n ifica n t at 24 b u t n ot at 36 m on th s. T h u s, it w o u ld appear that partial reten tion o f sealan t p ro v id ed sig n ific a n t p ro tectio n again st caries u p to 24 m on th s. T he in c id e n c e o f caries in teeth w ith co m p lete lo ss o f sealan t at 24 and 36 m o n th s is a lso presented. A t 24 m o n th s, se v e n sealant-treated a n d three c o n trol teeth h ad b eco m e carious. T h is d ifferen ce is n ot sta tistica lly sig n ifica n t.
d e n ce o f caries in sealant-treated teeth and in u n treated con trol teeth w a s com pared (Illustration). From six to 36 m on th s, th e p ercen t o f untreated (control) teeth that b ecam e carious in creased from ap p roxim ately 23% to 53%. In contrast, in sealanttreated teeth , th e in crease in caries from six to 36 m on th s w a s from 1% to 8%. T hus, th e difference in th e in c id e n c e o f caries b e tw e en sealant-treated and untreated teeth at six m on th s w as 22% and at 36 m o n th s, 45% . T h is difference in d ic a tes that sealant treatm ent p ro v id ed sig n ific a n t p ro tectio n o f the treated teeth again st caries for th is p eriod. In th e Illu stra tio n , an in v e r se r e la tio n sh ip is sh o w n b e tw e e n reten tion and in creased in c id e n c e o f caries. T h u s, a 10% red u ctio n in reten tion o f se a l ant, from 97.4% at six m on th s to 87.5% at 36 m on th s, is a cco m p a n ied b y a 7% in crease in th e rate of caries. H ow ever, b ecau se o f th e lo w rate o f caries, th e rela tio n sh ip can n ot be c o n sid ered sta tistic a lly sig n ifi cant.
C o m p le te r e te n tio n o f s e a la n t a n d i n c id e n c e o f c a r ie s
E f fi c a c y o f s e a la n t
T o d eterm in e further th e rela tio n sh ip b e tw e e n re ten tio n o f sea la n t and red u ctio n in caries, th e in c i
To d eterm in e the efficacy o f sealan t o n teeth at 24 and 36 m on th s, net gain and p ercen t e ffectiv en ess
Months Percent ofretention on treated teeth is shown by solid line; percent of caries on control teeth is shown by dashed line; percent of caries on sealant-treated teeth is shown by dotted line. M c C u n e -B o ja n in i-A b o d e e ly : E F F E C T IV E N E S S O F P I T A N D F IS S U R E S E A L A N T ■ 6 2 1
Table 5 ■ C o m p a r i s o n o f o c c l u s a l c a r i e s o f t r e a t e d a n d c o n t r o l te e t h ; n e t g a i n a n d p e r c e n t e f f e c tiv e n e s s ; e v a l u a t i o n a t 24 a n d 36 m o n th s . O c clu sa l c aries statu s E x a m in a tio n 24 m o n th s M ax illary M an d ib u lar T o tal 36 m o n th s M ax illary M an d ib u lar T o tal
T o tal no. o f p airs
C o n tro l te e th C ario u s
S ound
T rea te d teeth C arious
Sound
N et gain*
P e rc e n t effe c tiv e n ess!
143 109 252
45 48 93
98 61 159
3 4 7
140 105 245
42 44 86
93.3 91.792.5
155 117 272
71 73 144
84 44 128
11 11 22
144 106 250
60 62 122
84.5 84.9 84.7
*Net gain means carious control teeth minus carious treated teeth. fPercent effectiveness means net gain divided by carious control teeth multiplied by 100.
w ere d eterm in ed. T he n e t gain is an estim ate o f h o w m an y teeth w ere sav ed b eca u se o f a p p lica tio n of sealant. It is d eterm in ed b y subtracting th e num ber o f treated carious teeth from th e num ber o f control carious teeth . T able 5 sh o w s that th e n et g ain w a s 86 teeth sa v ed at 24 m o n th s and 122 teeth saved at 36 m on th s. T hu s, at 24 and 36 m on th s, resp ectiv ely , the n et gain w a s 34% and 45% o f th e sealant-treated teeth , that is, 34 and 45 teeth per 100 treated teeth esca p ed caries b eca u se o f a p p lica tio n o f sealant. T able 5 also in d ica tes that there is n o sig n ific a n t d if ference in n et gain b e tw e e n m axillary and m an d ib u lar m olars. T he percen t e ffe c tiv en ess is d efin ed as n et g ain d iv id e d by the num ber o f control carious teeth , m u ltip lie d by 100. T able 5 sh o w s percent ef fec tiv e n e ss v a lu e s o f 92.5% at 24 m o n th s and 84.7% at 36 m on th s.
Discussion T he resu lts o f th is stu d y in d ica te that co m p lete re ten tio n o f sealan t w as 88.9% an d 87.5% after 24 and 36 m on th s, resp ectiv ely . In a series o f stu d ies by Brooks and o th ers9-11 in A u gu sta, Ga, a cold -cu red p it an d fissu re sealant* w a s com p ared w ith sealan t cured w ith u ltra violet lig h t.t T he ch ild ren w ere ran d om ly se le c te d to re c e iv e eith er o f th e sealan ts on perm an en t first m olars on on e sid e o f the m outh. T he h o m o g o lo u s m olars o n the other sid e served as the control teeth. C om p lete reten tion w a s fo u n d in 84% of th e 233 teeth treated w ith co ld -cu red p it and fissu re sealan t at 24 m on th s com p ared w ith 58% of th e teeth treated w ith th e se a la n t cu r e d w ith u ltr a v io le t lig h t. A t 36 m on th s, the co ld -cu red sealan t w a s c o m p le te ly re tain ed in 80% o f th e 201 teeth ex a m in ed , w h ereas 60% w a s retained for th e other sealant. T h ese le v e ls o f co m p lete reten tion , as reported by Brooks and oth ers,9-11 are c o n siste n t w ith le v e ls fo u n d in the current study. M any c lin ic a l stu d ie s w ith other sealan ts h a ve in c lu d e d different ty p es o f teeth, often w ith a large proportion o f prem olars. G oing and oth ers3 c o n d u cted a stu d y in w h ic h 86 pairs o f perm an en t first 6 2 2 ■ J A D A , V o l. 9 9 , O c to b e r 1 9 7 9
m olars w ere exam in ed at 24 m on th s. A p p roxim ately 23% o f th e m olars treated w ith u ltraviolet ligh tcured sealan t had o c clu sa l caries, as com pared w ith ap p roxim ately 59% o f the controls. T h is d ifferen ce resu lted in an estim ated n e t ga in of 36%, or 31 teeth, and a p ercen t e ffec tiv en ess o f about 61%. In c o n trast, th e 24-m on th resu lts o f th e current stu d y in d i cate that o n ly se v e n (or ap p roxim ately 3%) o f the 252 cold -cu red , sealant-treated first m olars and 93 (or about 3 7%) o f th e con trol teeth w ere carious. T h is d ifference resu lts in an estim ated n et gain o f 86 teeth (34%) 'and a p ercen t effec tiv en ess o f ap p roxim ately 93%, after 24 m on th s. B rooks and oth ers9-11 com pared the effica cy o f the tw o sealan ts u n d er sim ilar c o n d itio n s. T he resu lts after 24 m on th s in d ica te th e n e t ga in o f th e ultra v io le t ligh t-cu red sealan t w a s 31 teeth sa ved from caries (258 treated) and 38% e ffectiv en ess. In c o n trast, at 24 m on th s, the n et gain o f the co ld -cu red p it and fissu re sealant w a s 61 teeth w ith o u t caries (233 treated) and 71% e ffectiv en ess. A t 36 m o n th s, th e re su lts from the stu d y by Brooks and others in d ica ted a n et gain o f 31 teeth sa v ed and 39% e ffec tiv en ess (205 treated) w ith the u ltraviolet ligh t-cu red system . A n et gain o f 59 teeth and 69% e ffec tiv en ess for the cold -cu red p it and fissu re sealan t (201 treated) w a s fou n d at 36 m on th s. T he resu lts p resen ted in th is re port and th o se o f Brooks and oth ers9-11 in d ica te that the cold -cu red p it and fissu re sealan t is h ig h ly effec tiv e in p reven tin g caries for 36 m on th s.
Summary W ith u se o f the h alf-m ou th tech n iq u e, a p it and fis sure sealan t w as a p p lied to the perm anent first m o lars of 200 ch ild ren b e tw e e n 6 and 8 years o f age in a co m m u n ity w ith flu o rid a ted w ater in C olom bia, S ou th A m erica. C om plete reten tion o f sealan t at 12, 24, and 36 m on th s after a p p lica tio n w a s 91.6% , 88.9% , and 87.5% , resp ectiv ely . Partial reten tion of sealan t w a s 5.8%, 7.1%, an d 8.5% at th e sam e inter vals. T he in c id e n c e o f caries in all sealant-treated teeth at 36 m on th s w a s 8% v s 53% in untreated paired teeth. O f th e 238 teeth that c o m p le te ly r e
tain ed sealant, o n ly o n e to o th h ad o c c lu sa l caries at 36 m on th s. N o sta tistic a lly sig n ific a n t d ifferen ce in co m p le te r eten tio n b e tw e e n m a x illa ry an d m a n dibular m olars w a s n o tic e d at a n y exam in ation . T he stu d y con firm s that th is co ld -cu red p it and fissu re sealan t is effectiv e in p rotectin g the o c c lu sa l surfaces o f teeth aga in st caries for at lea st three years.
*D elton, Jo h n so n & Jo h n so n , E ast W in d so r, NJ. tN u v a -S e a l, L. D. C au lk Co., M ilfo rd , Del. Dr. M cC une is v ic e -p re sid e n t, re s e a rc h a n d d e v e lo p m e n t, Jo h n so n & Jo h n so n D en tal P ro d u c ts C o; Dr. B o ja n in i is d ire c to r o f d e n ta l s ec tio n , S ec re ta ry of H e a lth a n d S o c ia l W elfare, M u n ic ip a lity o f M e d e llin , C olom bia, S o u th A m erica; a n d Dr. A b o d e e ly is d ire c to r o f re g u la to ry a ffairs a n d q u a l ity a ssu ra n c e , J o h n so n & Jo h n so n D e n tal P ro d u c ts Co. A d d re ss re q u e sts for re p rin ts to Dr. M cC une, J o h n so n & Jo h n so n D e n tal P ro d u c ts Co., 20 Lake Dr, E ast W in d so r, NJ 08520. 1. B uo n o co re, M .G. C aries p re v e n tio n in p its a n d fissu re s se a le d w ith a n a d h e s iv e re s in p o ly m e riz e d b y u ltra v io le t lig h t: a tw o -y ear s tu d y o f a s in g le a d h e s iv e a p p lic a tio n . JADA 8 2 (5 ):1 0 9 0 -1 0 9 3 ,1971. 2. G oing,R .E., a n d o th e rs. T w o -y ea 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 sea la n t. R e ten tio n a n d lo ss o f s u b sta n c e. JADA 9 2 (2 ):3 8 8 -3 9 6 ,1976.
3. G oing, R.E., a n d o th e rs. T w o -y ea r c lin ic a l e v a lu a tio n of a p it a n d fis s u re s ea la n t. C aries in itia tio n a n d p ro g re ssio n . JADA 9 2{3):578-585,1976. 4. G oing, R.E., a n d o th e rs. F o u r-y e ar c lin ic a l e v a lu a tio n o f a p it a n d fis s u re se a la n t. JADA 95(5):972-981, 1977. 5. M cC une, R.J., a n d o th e rs. P it a n d fissu re sea la n ts: o n e -y e ar re su lts fro m a s tu d y in K a lisp e ll, M o n tan a. JADA 8 7 (5 ):1 1 7 7 -1 1 8 0 ,1973. 6. H o ro w itz , H .S.; H eifetz, S.B.; a n d M cC une, R.J. T h e e ffectiv en ess of a n a d h e s iv e s e a la n t in p re v e n tin g o c clu sa l caries. F in d in g s a fter tw o years in K a lisp e ll, M o n tan a . JADA 8 9 (4 ):8 8 5 -8 9 0 ,1977. 7. B ag ra m ia n , R.A .; G raves, R .C.; a n d S riv asta v a , S. S e a la n t e ffe c tiv e n e ss fo r c h ild re n re c e iv in g a c o m b in a tio n of p re v e n tiv e m e th o d s in a flu o rid a te d c o m m u n ity : tw o -y e a r re su lts. J D en t R es 56(12):1511-1519, 1977. 8. B o ja n in i, J.D., a n d o th e rs. E ffectiveness of p it a n d fissu re se a la n ts in th e p re v e n tio n o f c aries. J P rev D e n t 3 (6 ):3 1 -3 4 ,1976. 9. B rooks, J.D., a n d o th e rs. R e ten tio n a n d efficacy o f tw o p it a n d fissu re s ea la n ts. IADR A b stra cts, no. 7 0 2 ,1 9 7 6 . 10. B rooks, J.D., a n d o th e rs. T w o -y ea r c lin ic a l e v a lu a tio n of th e re te n tio n a n d efficacy o f tw o p it a n d fissu re sea la n ts. IADR A b stra cts, no. 73, B 7 0 ,1977. 11. B rooks, J.D., a n d o th e rs. T h ree -y e a r c lin ic a l e v a lu a tio n o f th e re te n tio n a n d efficacy o f tw o p it a n d fissu re sea la n ts. IADR A b stracts, no. 1140, A 359, 1978. 12. H o u p t, M ., a n d S h e y k h o le slam , Z . T h e c lin ic a l effe c tiv e n ess o f Delto n fissu re s e a la n t a fte r e le v en m o n th s. IADR A b stra cts, no. 799, B 251, 1977. 13. B ross, J. Is th e re a n in c re a se d ris k ? F e d P ro c 1 3 :8 1 5 ,1 9 5 4 .
M c C u n e -B o ja n im -A b o d e e ly : E F F E C T IV E N E S S O F P I T A N D F IS S U R E S E A L A N T ■ 6 2 3