RESEARCH
ULTRACONSERVATIVE AND CARIOSTATIC SEALED RESTORATIONS:
RESULTS AT YEAR 10
EVA J. MERTZ-FAIRHURST, D.D.S.; JAMES W. CURTIS JR., D.M.D.; JANET W. ERGLE, C.D.A.; FRED A.
RUEGGEBERG, D.D.S., M.S.; STEVEN M. ADAIR, D.D.S., M.S.
The traditional treatment for
carious lesions was outlined
nearly a century ago by G.V.
Black.1 This treatment consists
of the removal of the carious le-
sion, including all demineral-
ized dentin and unsupported
enamel rods. Tooth preparation
that follows these guidelines
must also provide sufficient
room for placement of a restora-
tive material, based primarily
on the physical properties of the
material itself. Furthermore,
the preparations are extended
to include pits and fissures that
may at some future date be-
come carious (extension for pre-
vention). Finally, cavity prepa-
ration, according to Black,
requires the removal of tooth
structure to prepare a specifi-
cally dictated outline form as
well as an internal form that
provide for mechanical reten-
tion of the restoration.
Adherence to these tradition-
al guidelines results in removal
of sound tooth structure, howev-
er. The net result is that the
final preparation for a very lim-
ited carious lesion can involve
extensive loss of healthy enamel
and dentin.
In 1969, Keyes2 described the
three groups of causative fac-
tors (illustrated as overlapping
circles) essential in the etiology
Copyright ©1998-2001 American Dental Association. All rights reserved.
A B S T R A C T
Changes in restorative tech-
niques and the development of
newer restorative materials have
allowed for the use of more con-
servative cavity preparations.
This 10-year study evaluated
bonded and sealed composite
restorations placed directly over
frank cavitated lesions extend-
ing into dentin vs. sealed conser-
vative amalgam restorations and
conventional unsealed amalgam
restorations. The results indi-
cate that both types of sealed
restorations exhibited superior
clinical performance and longevi-
ty compared with unsealed amal-
gam restorations. Also, the bond-
ed and sealed composite
restorations placed over the
frank cavitated lesions arrested
the clinical progress of these le-
sions for 10 years.
of caries:
da susceptible host;
dcariogenic microflora;
da suitable substrate (mainly
the sugars in the host’s diet).
All three groups of causative
factors must interact simultane-
ously for caries to occur or
progress. Thus, it is reasonable
to expect that if the source of
nutrition for the cariogenic bac-
teria could be eliminated, the
organisms would die, thus ar-
resting the carious process.
Therefore, a bonded and sealed
composite restoration placed
over a frank cavitated lesion
could form a physical barrier
against nutrients from the oral
cavity. Without these nutrients,
the cariogenic organisms within
the sealed lesion would not
thrive, leading to a halt in the
carious process. The substrate
circle that Keyes described
would be prevented from inter-
acting with the other two cir-
cles, although the host and bac-
teria circles would still overlap
because the bacteria would re-
main inside the host’s tooth.
The success of enamel etch-
ing and resin bonding in greatly
reducing or virtually eliminat-
ing microleakage at the inter-
face between the etched enamel
and resin is well documented.3,4
Resin tags penetrate into the
etched enamel, forming a physi-
cal barrier at the microscopic
level against the entry of bacte-
ria and nutrients from the oral
JADA, Vol. 129, January 1998 55
RESEARCH
cavity. Thus, a properly placed
bonded and sealed Class I
restoration has the potential to
preclude the progression of a
carious lesion sealed within the
tooth.
The purpose of this con-
trolled clinical study was to use
two modalities to evaluate the
effectiveness of treating frank
cavitated lesions:
dsealed composite restorations
placed over the carious lesion;
dremoval of the carious lesion
and placement of ultraconserva-
tive, localized sealed amalgam
restorations without an exten-
sion for prevention.
We then compared these two
modalities with the traditional
unsealed Class I amalgam
restoration, including the exten-
sion-for-prevention cavity out-
line form. This article summa-
rizes the observed results for
each of the three restorative ap-
proaches over a 10-year clinical
trial period.
MATERIALS AND
METHODS
The materials and methods
used in this study have been de-
scribed elsewhere,5-10 but de-
scriptions of the patient selec-
tion criteria, lesions, procedures
and materials follow. All opera-
tors and evaluators were den-
tists. The operators were trained
regarding the specific restora-
tive techniques and the evalua-
tors were calibrated to enhance
interexaminer reliability.
Patient selection criteria.
To be included in the study,
each person must have had at
least two Class I lesions in pre-
molars or permanent molars,
and the carious lesions must
have been clinically and radio-
graphically obvious.
The selection of study lesions
required that permanent mo-
56 JADA, Vol. 129, January 1998
Copyright ©1998-2001 American Dental Association. All rights reserved.
lars be paired only with perma-
nent molars and premolars with
premolars. There were 131
molar pairs and 25 premolar
pairs. The procedures, possible
discomforts or risks, and possi-
ble benefits were explained
fully to subjects, and their in-
formed consent was obtained
before the investigation.
Lesion characteristics. We
screened patients who had at
least two clinically obvious cavi-
tated lesions with bitewing ra-
diographs to confirm that each
lesion extended into the dentin
but was no deeper than halfway
into it. The judgment that a le-
sion on a radiograph was halfway
into dentin was estimated as
half the distance between the
dentinoenamel junction, or
DEJ, and the pulp chamber or
between the DEJ and the near-
est pulp horn. We did not accept
lesions confined to the enamel
and we excluded teeth with
proximal caries.
Restorations. Conventional
amalgam restorations. At base-
line, 123 patients (43 males, 80
females), aged 8 to 52 years (the
median age was 23 years), re-
ceived either a localized sealed
amalgam, or AGS, restoration
that was not extended for pre-
vention or an unsealed amal-
gam, or AGU, restoration that
was prepared using the tradi-
tional principles for Class I cav-
ity form in which the preparation
was extended into noncarious fis-
sures to prevent future caries ac-
tivity. We completely removed
soft demineralized dentin and
chalky white demineralized
enamel for both types of amal-
gam preparations. We did not
remove dentin or enamel that
was stained and hard.
Conservative amalgam
restorations. For the AGS
restorations, the dentist opera-
tor removed all soft demineral-
ized dentin only in the localized
area of the carious lesion, but
the preparation was not extend-
ed into unaffected fissures and
grooves. If two separate occlusal
lesions were present, they were
not combined into a single larger
amalgam restoration. Instead,
two small localized cavity prepa-
rations were made, except when
the distance between the two
cavity preparations would be
less than 0.5 millimeters. After
the amalgam was placed, the
operator applied sealant over
the restoration and all pits and
fissures of the tooth.
Cariostatic sealed composite
restorations. For each patient,
we paired one of these amalgam
restorations with a bonded and
sealed composite, or CompS/C,
restoration placed over caries,
for a total of 156 pairs of study
teeth, or a total of 312 teeth.
Treatment assignment
(CompS/C and AGS or AGU)
was statistically randomized for
each study tooth.
The only preparation for the
CompS/C restorations consisted
of placing a 45- to 60-degree
bevel in the enamel surround-
ing the frank cavitated lesion.
This occlusally divergent bevel
had to be at least 1 mm wide
and placed in sound enamel. We
removed all of the crumbly,
opaque demineralized enamel
with a bur until we reached
translucent sound enamel. We
did not remove undermined
enamel or caries below the
bevel.
During the operative proce-
dures at baseline, if the opera-
tor inadvertently removed all of
the soft dentin, the potential
study tooth was disqualified for
the CompS/C restoration be-
cause a carious layer of soft
dentin had to remain below the

bevel to qualify the tooth for the
CompS/C restoration. The deep
soft portions of the cavity re-
mained untouched. After place-
ment of the bevel, we frequently
observed shreds of carious
dentin or other material hang-
ing below the bevel toward the
soft and wet pulpal floor of the
cavity.
After placement of the bevel,
the operator washed the cavity
and dried the bevel. Some of the
previously observed hanging
shreds were washed out, but
others remained. A layer of soft
and wet-looking dentin in the
pulpal area of the cavity re-
mained intact, and there was
absolutely no instrumentation
below the enamel bevel. The op-
erator next thoroughly dried
and etched the bevel and the
adjacent enamel for 60 seconds.
The bonding agent was placed
on the bevel and the adjacent
etched enamel. The operator
then used hand instruments to
place a self-curing composite
material.
After a final shaping of the
occlusal anatomy with rotary
instruments, the operator then
etched all of the occlusal, buccal
and lingual pits and fissures for
60 seconds, washed the etchant
thoroughly and applied a chem-
ically cured sealant. The
sealant, which was applied with
an applicator supplied in the
sealant kit, was placed over the
entire restoration and adjacent
etched enamel as well as over
all of the pits and fissures of the
tooth.
When the sealant was set in
the mixing well, the operator
waited another 30 seconds to
ensure that the sealant was
also set on the tooth. The opera-
tor then wiped the sealed tooth
with a wet cotton roll, dried it
with an air syringe and inspect-
Copyright ©1998-2001 American Dental Association. All rights reserved.
FOUR-CELLED* STUDY DESIGN.
GROUP 1
Teeth with bonded and
sealed composite restora-
tions over caries
(CompS/C) (n = 77)
GROUP 3
Teeth with sealed amalgam
(AGS) restorations (n = 77)
*Groups 1 and 3 and groups 2 and 4 were compared directly in the same patients. Different
patients in Group 1 were compared with different patients in Group 2. Likewise, different
patients in Group 3 were compared with different patients in Group 4.
ed it to ensure that all of the
pits and fissures and the entire
restoration with the adjacent
enamel were completely sealed.
If they were not completely
sealed, the area or areas in
question were re-etched for 30
seconds and resealed. The rub-
ber dam was removed and the
dentist made necessary occlusal
adjustments.
Materials. The materials
used included Delton yellow-
tinted, chemically cured pit and
fissure sealant (L. D. Caulk,
Dentsply Division [at the time
of the study, the sealant was
manufactured by Johnson &
Johnson Dental Products Co.]),
radiopaque chemically cured
Miradapt composite restorative
material (Johnson & Johnson
Dental Products Co. [the mate-
rial is no longer manufactured])
and Dispersalloy amalgam
(L. D. Caulk, Dentsply Division
[at the time of the study, the
amalgam was manufactured by
Johnson & Johnson Dental
Products Co.]).
Study design. The study de-
sign was four-celled, as shown
in the box (“Four-Celled Study
Design”). This type of design al-
lowed us to compare the four
RESEARCH
GROUP 2
Teeth with bonded and
sealed composite restora-
tions over caries
(CompS/C) (n = 79)
GROUP 4
Teeth with unsealed amal-
gam (AGU) restorations
(n = 79)
groups of restorations, with the
added advantage that Group 1
(n = 77) and Group 2 (n = 79)
CompS/C restorations could
also be combined into a
CompS/C study cell consisting
of 156 CompS/C restorations.
This double-sized CompS/C cell
represented the greatest devia-
tion from the traditional ap-
proach to treating pit and fis-
sure caries and was designed to
test not only the clinical
longevity of service but also to
monitor any progression of the
carious lesions under the sealed
composite restorations.
Criteria for clinical evalu-
ation. The three types of study
restorations were evaluated
clinically according to the modi-
fied Ryge criteria10 and accord-
ing to further subcategories of
the marginal integrity, or MI,
criteria.8 The Ryge criteria,
ranging from the best rating to
the worst, are as follows:
dOscar is excellent;
dAlfa is very good;
dBravo means a defect is pres-
ent but the restoration is still
clinically acceptable and does
not require replacement;
dCharlie is a clinical failure of
the restoration involving ex-
JADA, Vol. 129, January 1998 57
RESEARCH

Figure 1B. At year 6, there is no evidence of

Figure 1A. Preoperative radiograph of the mandibu-
progress of the lesions shown in Figure 1A.
lar right first and second molars (teeth no. 30 and
31) of a 26-year-old woman showing a rather large le-
sion in the central pit area of tooth no. 30 and a sep-
arate, barely visible lesion in the mesial pit of this
tooth. There is also a barely visible lesion in the cen-
tral pit of tooth no. 31. These teeth were randomly
assigned to receive bonded and sealed composite
restorations over caries (amalgam restorations were
placed in other teeth).

posed dentin or base and re- rence of open

quires immediate attention;
dDelta implies a clinical fail-
ure so extensive that the
restoration is mobile, fractured
or missing and also requires im-
mediate attention.
All examiners used a mirror
and an explorer, without the aid
of magnification, during the
clinical evaluations.
RESULTS
Figure 1 shows standardized ra-
diographs of two teeth with
CompS/C restorations. Figures 2
and 3 are intraoral photographs
of each of these CompS/C teeth.
The lack of progress of the cari-
ous lesions under the CompS/C
restorations in these two teeth is
typical for the CompS/C group.
Table 1 shows the study re-
sults at baseline and at year 10.
Of the original 156 pairs of study
teeth, 85, or 54 percent, were
evaluated at year 10; there were
85 CompS/C, 44 AGS and 41
AGU study restorations.
Partial and complete
retention of sealant over
restorations and the occur-
margins. An
open margin is
defined as a vis-
ible crevice de-
tectable by an
explorer tip,
which is drawn Figure 1C. At year 10, the lesions in Figure 1A are
well-delineated and not progressing, the distance be-
lightly and gen- tween the carious lesions and the pulp is not de-
tly back and creasing and the pulp is not in danger in either tooth
no. 30 or 31.
forth across all
margins of the restoration in a showed partial sealant reten-
continuous motion perpendicular tion with no open margins. Two
to the cavosurface margin. The percent of the AGS restorations
Ryge criteria for MI in this study but none of the CompS/C
pertain not only to the status of restorations fell into the Alfa
the margins but also include the category, in which there was no
degree of sealant retention over sealant retention but also no
the sealed restorations. open margins. Fifty-six percent
Table 1 shows the clinically of the AGU restorations had no
acceptable MI ratings of the open margins.
study restorations. The columns The number of restorations
labeled Oscar, Oscar/Alfa and with completely sealed margins
Alfa refer to restorations that in the CompS/C and AGS
had no open margins. At year groups tended to decrease,
10, 16 percent of the CompS/C whereas the number of partly
restorations and 25 percent of sealed restorations without any
the AGS restorations exhibited open margins increased steadily
complete sealant retention. over the 10-year observation pe-
Fifty-four percent of the riod. These two patterns repre-
CompS/C restorations and 57 sented some wear of the sealant
percent of the AGS restorations over the CompS/C and AGS

58 JADA, Vol. 129, January 1998

Copyright ©1998-2001 American Dental Association. All rights reserved.

Figure 2A. Clinical photograph of a mirror image of Figure 2B. Tooth no. 30 immediately after the
two preparations (bevels in the central and mesial restorative procedure.
pit areas) of tooth no. 30 shown in Figure 1. There
was no excavation of soft caries below the bevels.
Part of the mesiolingual aspect of the tooth is cut subcategory
off in this photograph. (Oscar/Alfa)
consisted of
restorations that remained
partly sealed; that is, more than
50 percent of the margins re-
mained sealed and there were
no open margins. This subcate-
gory had a wide range of
sealant retention (that is, 51 to
99 percent of margins remain-
ing sealed) over restoration
margins. At year 10, 36 percent
of the CompS/C restorations
and 45 percent of the AGS
restorations were in this largest
subcategory.
At year 10, the percentage of
remaining sealed restorations
that had no open margins and
varying amounts of sealant (rat-
ings of Alfa, Oscar/Alfa, Oscar)
Figure 2C. Tooth no. 30 at year 10. was 70 percent for the CompS/C
restorations and 84 percent for
restorations. the AGS restorations. As shown
Other subcategories of MI in Table 1, only 56 percent of
among the sealed restora- the AGU restorations had the
tions. As of the third year of Alfa rating at year 10.
the study, we subdivided the Open margins. Although
Ryge MI criteria into additional the margins of the restorations
subcategories to better differen- were never forcibly probed, the
tiate the marginal status of the explorer tip would perceptibly
sealed restorations.8 Among the drop into the defect as it was
sealed restorations, the largest moved across the margin. Once
Copyright ©1998-2001 American Dental Association. All rights reserved.
RESEARCH
the explorer tip encountered a
crevice, the explorer tip entered
it and then was blocked from
continuing in either direction
(that is, from the tooth to the
restoration or from the restora-
tion to the tooth). Table 1 shows
the percentage of open margins
for the CompS/C and AGS
restorations that remained in
single digits after 10 years.
According to the Ryge crite-
ria, some restorations with open
margins are clinically accept-
able; that is, they require obser-
vation rather than replacement.
Seven percent of CompS/C
restorations and 9 percent of
AGS restorations had open
margins that remained partly
sealed after 10 years. In addi-
tion, 1 percent of CompS/C
restorations lost all of the
sealant and had an open mar-
gin (Bravo MI), which means
that a total of 8 percent of
CompS/C restorations had an
open margin. Thus, 8 percent of
CompS/C, 9 percent of AGS and
29 percent of AGU restorations
had open margins at year 10.
Because the percentage of open
margins in the sealed restora-
tions remained in single digits,
JADA, Vol. 129, January 1998 59
RESEARCH

Figure 3A. Clinical postoperative photograph of tooth Figure 3B. Tooth no. 31 at year 6.
no. 31, which was shown in the radiographs of
Figure 1.

their clinical degradation over caries around

10 years was usually limited to the restoration
minor transitions from Oscar to that the study
Oscar/Alfa, thus representing restoration is
only superficial sealant wear. mobile, frac-
In contrast with the infre- tured or miss-
quent and minor degradation of ing). One of the
MI seen in the sealed restora- seven AGU fail-
tions, the development of open ures received
margins (Bravo MI) of the AGU the Delta caries
restorations reached 43 percent rating, and the
at year 5 and then declined to remaining six
29 percent at year 10, as shown AGU failures
in Table 1. This apparent de- received the
cline in the percentage of open Charlie caries
margins was offset by the AGU rating.
group’s large shift resulting We should
from clinical failures, all of note, as shown
which were due to caries. Seven in Table 1, that
of these AGU failures were ob- at the begin-
served through year 10. ning of the Figure 3C. Tooth no. 31 at year 10.
Thus, the high occurrence of study, 4 per-
open margins in the AGU group cent of CompS/C and 6 percent this absence of sealant or the
peaked at year 5, and then the of AGS restorations had only presence of only partial sealant
open margin ratings (Bravo MI) partial sealant coverage; also, coverage over the CompS/C and
deteriorated to ratings of either 10 percent of CompS/C and 4 AGS restorations was usually
Charlie (denoting softness and percent of AGS restorations had due to occlusal adjustment of
opacity of enamel or dentin) or no sealant at all at the begin- the sealant after the operator
Delta (denoting such extensive ning of the study. At baseline, removed the rubber dam.

60 JADA, Vol. 129, January 1998

Copyright ©1998-2001 American Dental Association. All rights reserved.
 RESEARCH

TABLE 1

RESULTS AT BASELINE AND AT YEAR 10.

YEAR NO. OF RESTOR- CLINICALLY ACCEPTABLE CLINICAL UNRELATED OTHERS
TEETH ATION MARGINAL INTEGRITY RATINGS FAILURES FAILURES (% OF TEETH)
TYPE* (% OF TEETH) (% OF TEETH) (% OF TEETH)

Oscar† Oscar/ Alfa§ Oscar/ Bravo††

Alfa‡ Bravo**

156 Comp- 86 4 10 0 0 0 0 0
S/C
Base-
line 77 AGS 90 6 4 0 0 0 0 0

79 AGU NA‡‡ NA 100 NA 0 0 0 0

85 Comp- 16 54 0 7 1 13 4 5
S/C
10
44 AGS 25 57 2 9 0 0§§ 2 4

41 AGU NA NA 56 NA 29 15 0 0

* CompS/C: bonded and sealed composite restoration over caries; AGS: sealed amalgam restoration; AGU: unsealed amalgam
restoration.
† Restoration, including all margins, is completely sealed.
‡ Restoration is partly sealed and has no open margin—that is, the restoration has no visible crevice and either the explorer does not catch or
it catches only one way.
§ There is no sealant but no open margin.
** The restoration is partly sealed and there is an open margin (a visible v-shaped crevice at the margin or one determined by an explorer catch
in both directions), but no dentin or base is exposed. (The terms open margin and crevice are interchangeable.)
†† There is no sealant and there is an open margin.
‡‡ NA: not applicable.
§§ There was a single clinical failure in the group that received the bonded and sealed amalgam restorations. The failure occurred at year 4, but
the patient did not come for an evaluation at year 10.

Statistically, there was no
significant difference through
year 10 in the number of open
margins, compared with the
number of closed margins, for
the AGS and CompS/C groups
of restorations (χ2 = 0.0133,
P = .91). The AGS group had a
significantly lower number of
open margins than did the AGU
group (χ2 = 6.8356, P = .009).
The CompS/C group also
showed a significantly smaller
number of open margins than
the AGU group (χ2 = 8.6189,
P = .003). These findings dem-
onstrate that the traditional
AGU restorations fared the
worst of the three groups with
regard to the occurrence of open
margins.
Clinical failures of study
restorations. Over the 10-year
period, there were 25 clinical
failures, including five failures
that were unrelated to the study.
Clinical failures of restorations
through year 9 have been de-
scribed elsewhere.7-10 Table 2
shows the number of failures per
restoration type. The cumula-
tive number of clinical failures
at year 10 that were related to
the study included 12 in the
double-sized CompS/C group,
one in the AGS group and seven
in the AGU group.
Caries. Over the 10-year pe-
riod, caries occurred at the mar-
gin of only one CompS/C
restoration and one AGS
restoration. However, caries
was the only reason that the
seven AGU restorations failed.
As shown in Table 2, the clini-
cal failures in the AGU group
started to appear in year 4 of
the study and continued to
occur in subsequent years.
(Years 7 and 8 of the study were
unsupervised, so no data are
available for that period.)
Sealant failure. We defined
sealant failure as occlusal pit
and fissure caries that occurred
at a site other than the margin
of a study restoration. Through
year 10, three sealant failures
had occurred in the CompS/C
group. The first was observed at
year 2; the second and third
were observed at year 9. In the
AGS group, there were two
sealant failures, one of which
was observed at year 3 and the
other at year 9.
Restoration failure. For
the AGU restorations, develop-
ment of occlusal caries that was
not at the margin of the study
restoration was considered a
failure of the extension-for-pre-

JADA, Vol. 129, January 1998 61

Copyright ©1998-2001 American Dental Association. All rights reserved.
RESEARCH

TABLE 2
OCCURRENCE OF CLINICAL FAILURES OF RESTORATIONS THROUGH YEAR 10.
TIME
Bonded and Sealed
Composite Restorations
(n = 156 at Baseline)
Six months-
two years
Three years
Four years
Five years
Six years
Nine years
Ten years
Cumulative
failures through
year 10
* U: clinical failure unrelated to the study.
† The percentage is calculated by dividing the number of cumulative failures related to the study by the number of
restorations evaluated at year 10.
vention concept, and, therefore,
it was a restoration failure. One
of these was observed in an
AGU restoration at year 9.
Unrelated clinical fail-
ures. Five clinical failures un-
related to the study occurred.
Three intact study restorations
had to be removed to achieve
access to unrelated proximal
caries, and two teeth were even-
tually extracted as a result of
unrelated gingival (Class V) le-
sions.
Restoration survival. We
used Wilcoxon’s test to analyze
the survival of the restorations
to determine the homogeneity of
the survival curves of the mate-
rials.11 Table 3 shows the re-
sults of this analysis. We found
that the longevity of the
restorations in the AGU and
CompS/C groups was the same.
Furthermore, the longevity of
the restorations in the AGS
group, which recorded only one
clinical failure related to the
NO. OF FAILURES
Sealed Amalgam
Restorations
Over Caries (n = 77 at Baseline) (n = 79 at Baseline)
1 0 + 1 U*
3 + 1 U* 0 0
4 1
1 0
0 + 1 U* 0 1
3 + 2 U* 0 2
0 0
12 + 4 U* 1 + 1 U*
(14%)† (n = 85) (2%)† (n = 44)
study, was significantly better
than the longevity of the
restorations in the other two
groups.
Others. At year 9, six (8 per-
cent) of the 75 CompS/C
restorations that remained and
two (5 percent) of the 40 AGS
restorations that remained
could not be evaluated because
of circumstances that could not
be controlled during the unsu-
pervised years 7 and 8 of the
study. During that period, four
CompS/C restorations had been
replaced for unknown reasons
(probably because they had ap-
peared radiographically unusu-
al to dentists who were unfamil-
iar with this study).
In addition, one CompS/C
study restoration and one AGS
restoration had been placed in
third molars that were extract-
ed between years 6 and 9 of the
study. Neither patient knew
why the teeth were extracted
since neither had experienced
pain or other
symptoms.
The AGS
tooth of one
Unsealed Amalgam
patient was
Restorations avulsed in a
car accident.
At year 10, we
0 saw some of
these pa-
tients, and
2
again four (5
percent) of the
1 80 CompS/C
restorations
that remained
and two (4
1 percent) of the
7 50 AGS
(17%)† (n = 41) restorations
that remained
could not be
evaluated.
Wear.
Table 4 shows the anatomic
form, or the modified Ryge cri-
teria for wear of restorations
(one criterion, Hotel, was devel-
oped by one of the authors). At
year 10, 10 percent of the AGU
restorations showed clinically
acceptable wear (Bravo). We
saw this same level of wear in
only 3.5 percent of the CompS/C
restorations and in none of the
AGS restorations.
The CompS/C restorations in
two patients had abnormally
high occlusal stresses and
showed a complete loss of
sealant and generalized wear.
Once the entire enamel bevel
was completely exposed, these
two CompS/C restorations lost
their bond to enamel and were
missing at the next evaluation
(Delta anatomic form failures).
Thus, the dentist evaluators did
not see the Charlie anatomic
form, in which dentin is exposed
as a result of wear. We should
note that these two CompS/C

62 JADA, Vol. 129, January 1998

Copyright ©1998-2001 American Dental Association. All rights reserved.

study teeth had previously been
misclassified as Delta MI fail-
ures.8,9
DISCUSSION
Since the introduction of pit and
fissure sealants into clinical
practice, dentists have been
concerned that undetected
small carious lesions could
progress under a sealant. This
10-year study might help to al-
leviate such fears regarding
sealed-in lesions. These results
may have contributed to an
understanding of the behavior of
the carious process in that a
frank cavitated lesion can be
arrested both clinically and radio-
graphically over a long (10-year)
period by means of bonded and
sealed composite restorations. It
is highly probable that once they
have been arrested, these dor-
mant lesions have stabilized and
will not progress. As long as
etched enamel is present around
the periphery of the lesion, a
bonded and sealed restoration
will cut off the nutrients from the
oral cavity to the cariogenic bac-
teria in the lesion and prevent
any further progress of the cari-
ous process.
This study confirms Keyes’
concept of caries etiology.2 A pre-
vious clinical study,12,13 which in-
cluded microbial sampling and
an evaluation of bacterial viabili-
ty in sealed carious lesions,
showed that such lesions became
sterile and clinically inactive.
The use of a pit and fissure
sealant to protect amalgam
margins was not a common
practice when we began this
study. Because this appeared to
be a logical extension of sealant
use, a scanning electron micro-
scopic study was conducted14 to
evaluate the extent of sealant
penetration into the interfacial
gap between the margins of the
Copyright ©1998-2001 American Dental Association. All rights reserved.
TABLE 3
SURVIVAL ANALYSIS USING WILCOXON’S TEST AT YEAR 10.
COMPARISON GROUP
77 Bonded and sealed
composite restorations over
caries (CompS/C) vs. 79
CompS/C restorations*
77 CompS/C restorations
vs. 77 sealed amalgam
(AGS) restorations†
79 CompS/C restorations
vs. 79 unsealed amalgam
(AGU) restorations†
77 AGS restorations vs. 79
AGU restorations*
* Comparison of two groups of restorations in different patients.
† Direct comparison of restorations in the same patient.
amalgam and the cavity walls.
The results of that study
showed that deep penetration of
sealant did occur; hence, we in-
corporated the technique into
this study.
Sealants highly success-
ful. The results indicate that
using sealant as a means of
maintaining MI is highly suc-
cessful and should be adopted
as an improved technique for
placing Class I amalgam
restorations. Moreover, such
minimal localized cavity prepa-
ration and sealing of the re-
maining occlusal pits and fis-
sures result in an amalgam
restoration that prevents the
development of caries and is
less invasive.
When conducting long-term
studies on arresting caries with
sealants or with bonded and
sealed restorations placed over
caries, investigators should pro-
vide operative treatment for
teeth that are not part of the
study to prevent dentists unfa-
miliar with the research design
from interfering with the study
teeth. Except for the period cov-
RESEARCH
P-VALUE
0.8990 (Not significant)
0.0322 (Significant difference;
AGS is superior)
0.8320 (Not significant)
0.0242 (Significant difference;
AGS is superior)
ering years 7 and 8, we provid-
ed free-of-charge operative care
for teeth not included in the
study. (Patients also received a
nominal annual fee to encour-
age their continued participa-
tion in the study.)
After the unsupervised two-
year interval, a total of eight
study teeth could not be evalu-
ated at year 9, because the orig-
inal study restorations had
been replaced or the study teeth
had been extracted or avulsed
in an accident. This inability to
evaluate all of the study teeth
did not occur at any other year.
Occlusal enamel undermined
by caries may be stronger than
what has been believed in the
past. Only one of the CompS/C
restorations appeared to cave in
(the enamel, which was very
thin, fractured at the edge of an
intact CompS/C restoration).
This single fracture of under-
mined enamel may have been
due to an operator’s error dur-
ing the bevel preparation at
baseline, which then resulted in
a failure to reach the 1 mm of
sound enamel that the protocol
JADA, Vol. 129, January 1998 63
RESEARCH

TABLE 4

MODIFIED RYGE CRITERIA10 FOR ANATOMIC FORM (WEAR).

YEAR NO. OF RESTORA- ALFA† AND BRAVO§ DELTA** CLINICAL FAIL- UNRELATED OTHER
TEETH TION TYPE* HOTEL‡ (% OF (% OF URES OTHER FAILURES FACTORS
(% OF TEETH) TEETH) TEETH) THAN ANATOMIC (% OF TEETH) (% OF
FORM TEETH)
(% OF TEETH)

Base- 156 CompS/C 100 0 0 0 0 0

line 77 AGS 100 0 0 0 0 0
79 AGU 100 0 0 0 0 0

1 126 CompS/C 100 1 0 1 0 0

63 AGS 100 0 0 0 2 0
63 AGU 100 0 0 0 0 0

2 119 CompS/C 99 1 A†† 0 1 0 0

59 AGS 100 0 0 0 2 0
60 AGU 100 0 0 0 0 0

3 128 CompS/C 95 1 B‡‡ 1A 3 0 0

65 AGS 95 3 0 0 2 0
63 AGU 98 2 0 0 0 0

4 123 CompS/C 93 0 2 A, B 7 0 0
62 AGS 95 2 0 2 2 0
61 AGU 93 3 0 3 0 0

5 116 CompS/C 88 3 2 A, B 8 1 0
60 AGS 97 0 0 2 2 0
56 AGU 93 2 0 5 0 0

6 100 CompS/C 90 0 2 A, B 9 2 0
51 AGS 96 0 0 2 2 0
49 AGU 92 4 0 8 0 0

9 75 CompS/C 68 0 3 A, B 16 5 8
40 AGS 91 0 0 2 2 5
35 AGU 80 3 0 17 0 0

10 85 CompS/C 70.6 3.5 2.4 A, B 14.1 4.7 4.7

44 AGS 90.9 0 0 2.3 2.3 4.5
41 AGU 73 10 0 17 0 0

* CompS/C: bonded and sealed composite restoration over caries; AGS: sealed amalgam restoration; AGU: unsealed amalgam
restoration.
† Restoration is neither undercontoured nor discontinuous.
‡ Restoration is neither undercontoured nor discontinuous, and it remains completely sealed.
§ Restoration is undercontoured and discontinuous, but neither the dentin nor the base is exposed.
** Restoration is mobile, fractured or missing as a result of the amount of material that has been lost to wear.
†† A: At year 2, loss of sealant and generalized wear below the cavosurface margin of the bevel (Bravo anatomic form), followed by loss of the
CompS/C restoration (Delta anatomic form) at year 3. (The patient had abnormally heavy occlusion, as described elsewhere.8,9)
‡‡ B: At year 3, generalized wear (Bravo anatomic form), followed by loss of the CompS/C restoration (Delta anatomic form) at year 4.
(The patient had abnormally heavy occlusion, as described elsewhere.8,9)

dictated. We observed no thin-
ning of undermined enamel
around any other CompS/C
restorations on the radiographs.
Dental caries is a globally
prevalent symptom of an infec-
tious bacterial disease transmit-
ted in early childhood (as soon
as primary teeth start erupting)
from parents or caretakers
through an exchange of saliva,
such as that which occurs when
eating utensils are shared.15-18
Historically, dental caries has
been treated by surgical exci-
sion. Sound tooth structure had
to be sacrificed to make up for
the shortcomings in the physi-
cal properties of various
restorative materials.
Medical model of treating
caries. With the advent of ad-
hesive dentistry, prevention of
caries and greater conservation
of tooth structure are possible.19
Even more important, there is
evidence that a shift in philoso-
phy from the traditional surgi-
cal model of excision to a more
modern medical model of treat-
ing caries may be occurring.20-26
Edelstein27 said that this reori-
entation advances the dentist to

64 JADA, Vol. 129, January 1998

Copyright ©1998-2001 Amer ican Dental Association.All rights reserved.

a new role as clinical cariolo-
gist. He also discussed one of
the barriers to an information
transfer, which could be related
to a lack of shared language be-
tween scientists and clinicians.
Even the word caries is used
differently by scientists and
clinicians; scientists refer to a
process and clinicians use it to
identify the lesions that result
from that process.
Other investigations.
Many investigators28-32 have sug-
gested altering traditional diag-
nostic techniques and ceasing to
use a sharp explorer to examine
the enamel for evidence of cari-
ous changes. A sharp explorer
might destroy the enamel over-
lying the initial surface lesion,
thus jeopardizing the possibility
of remineralization. A sharp ex-
plorer might also carry cario-
genic microorganisms from an
infected to a noninfected site.
Thus, a dentist who is perform-
ing a dental examination with
an explorer may be inoculating
the sound teeth of the patient
with infectious cariogenic bacte-
ria. In summarizing presenta-
tions given by several speakers
at a 1993 symposium, Bader
and Brown33 suggested that
there is no overall improvement
in diagnostic accuracy when an
explorer is used compared with
a detailed visual examination
involving careful drying of the
tooth.
Wenzel34 discussed newer
methods of diagnosing caries,
such as direct digital radiogra-
phy, fiber-optic transillumina-
tion and electrical resistance
measurements. However, these
technologies need to be evaluat-
ed further before they are rou-
tinely adopted in clinical prac-
tice.
During a joint symposium at
the 1993 meeting of the
Copyright ©1998-2001 American Dental Association. All rights reserved.
International Association for
Dental Research and the
American Association of Dental
Schools, Brown35 stressed the
need for a longitudinal clinical
risk assessment to discriminate
between progressive and remin-
eralized lesions. He stated that
treating caries restoratively in-
volves the probability of more
costly retreatment, and that
overtreatment of caries is possi-
bly the norm.
Hume36 stated that dentists
should modify their 200-year-
old philosophy that caries
should be treated like gangrene
by extracting or excavating and
filling. He advocated a treat-
ment approach based on the
structure and behavior of the
carious lesion. He further noted
that carious lesions in dentin
and cementum are reversible to
some degree and recommended
that clinicians include nonsur-
gical healing of these lesions in
the treatment plan.
Bader and Brown33 reported
that the prevalence of caries
has decreased and that carious
lesions may progress more slow-
ly. These changes in disease
patterns make it important to
determine the activity status of
a carious lesion and its poten-
tial for remineralization and
sealing. Anusavice37 provided
insight into the decision-making
processes related to restorative
dental care.
Pitts38 suggested that for
proper treatment decisions, it
may be logical to differentiate
“LANIMA” (that is, lesions for
which appropriate noninvasive
management is advised) caries
from “LOCA” (that is, lesions
for which operative care is ad-
vised) caries.
Perhaps in the future, re-
search might focus on the possi-
bility of remineralization of the
RESEARCH
carious dentin as a precursor to
restorative procedures.
CONCLUSIONS
Bonded and sealed composite
restorations placed over frank
cavitated lesions (CompS/C) ar-
rested the progress of these le-
sions over a period of 10 years.
Caries at the margin occurred
in only one CompS/C restora-
tion and one AGS restoration.
All failures of the AGU restora-
tions occurred as a result of
caries at the margin. Because of
the high occurrence of open
margins leading to caries at the
margins of AGU restorations,
we recommend that Class I
amalgam restorations be sealed
immediately after they have
been placed.
At year 10, 10 percent of the
AGU restorations, 3.5 percent
of the CompS/C restorations
and none of the AGS restora-
tions showed wear. Insofar as
the literature has reported wear
in composite restorations, we
conclude that the unfilled
sealant used in this study pro-
tected the posterior composite
restorations from any clinically
obvious wear, as evaluated ac-
cording to modified Ryge
anatomic form criteria.
The sealed restorations were
superior to the unsealed restora-
tions in conserving sound tooth
structure, protecting margins,
preventing recurrent caries and
prolonging the clinical survival
of the restorations. ■
Dr. Mertz-Fairhurst is professor emerita,
Department of Oral Rehabilitation, Medical
College of Georgia, School of Dentistry,
Augusta.
Dr. Curtis is an associate professor,
Department of Oral Rehabilitation, Medical
College of Georgia, School of Dentistry, 1120
Fifteenth St., Augusta, Ga. 30912-1260.
Address reprint requests to Dr. Curtis.
Ms. Ergle is a research assistant, Department
of Oral Rehabilitation, Medical College of
Georgia, School of Dentistry, Augusta.
JADA, Vol. 129, January 1998 65
RESEARCH
Dr. Rueggeberg is an associate professor,
Department of Oral Rehabilitation, Medical
College of Georgia, School of Dentistry,
Augusta.
Dr. Adair is an associate professor and
chairman, Department of Pediatric Dentistry,
Medical College of Georgia, School of
Dentistry, Augusta.
The first six years of this investigation were
supported financially by NIH/NIDR grant No.
DE 06112; years 9 and 10 were supported by
the NIH/NIDR Shannon award. Additional fi-
nancial support and clinical supplies were
provided by Johnson & Johnson Dental
Products Co., New Windsor, N.J.
The authors gratefully acknowledge the sig-
nificant contributions of the following people
in conducting this research: W. Frank
Caughman, D.M.D., M.Ed.; Gene L.
Dickinson, D.D.S., M.S.; I. Kin Hawkins,
D.D.S., Ph.D.; J. Rodway Mackert Jr.,
D.M.D., Ph.D.; Norris L. O’Dell, D.D.S.,
Ph.D.; E. Earl Richards, D.D.S., M.P.H.; Carl
M. Russell, D.M.D., M.S., Ph.D.; Deirdre R.
Sams, D.D.S., M.S.; George S. Schuster,
D.D.S., M.S., Ph.D.; Jack D. Sherrer, D.D.S.;
C. Douglas Smith, D.D.S.; and J. Earl
Williams, D.D.S., Dr.P.H.
The authors also thank Dr. S. Julian Gibbs
of Vanderbilt University, Nashville, Tenn., for
his assistance as a radiology consultant in the
design of the study and Mr. Warren Twiggs
for designing the computer database input
and report formats.
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