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177
A clinical comparison
Three restorative
materials and topical
fluoride gel used in
xerostomic patients
ABSTRACT
IO
N
R E S E A R C H
178
extremely scarce.
and Wilson17 found no conclusive evidence of
Glass ionomer restorations. In one two-year
decreased recurrent caries surrounding
clinical study, Wood and colleagues6 found that
glass ionomer restorations compared with other
glass ionomer restorations placed in patients
materials.
whose compliance with the daily use of a topical
Caries-protective effect. A significant
fluoride was less than 50 percent had increased
problem with studies of fluoride-releasing matelongevity compared with amalgam restorations.
rials is that much of the research evaluating the
However, they also found that in patients whose
caries-protective effects of glass ionomer restoracompliance with the daily use of a sodium fluotions has not focused on patients at high risk of
ride gel (pH, 5.8) was more than 50 percent, 32
developing caries, such as those with low salivary
(91 percent) of 35 glass ionomer restorations
flow, high Streptococcus mutans counts, or high
failed as a result of surface erosion. There was no
sucrose intake and poor plaque control. High
recurrent caries associated with these restoracaries rates are needed in clinical trials that evaltions, nor with any of the 35 amalgam restorauate the efficacy of fluoride-releasing materials to
tions placed in patients who used the sodium
provide a challenge that is severe enough to
fluoride gel more than 50 percent of the time.6
determine the effectiveness of these materials in
reducing the caries incidence. If the caries risk of
Although glass ionomer restorative materials
patients is low or if the sample size
have inferior mechanical properties
is too small to detect a difference in
compared with amalgam and resinpatients with low caries rates, the
based composite, they bond to tooth
Conflicting
study will not be able to detect a
structure and release fluoride. The
information exists
difference in the recurrent caries
fluoride release begins with an iniconcerning the
rates for teeth restored with
tial burst and rapidly declines to a
reduction in recurrent fluoride-releasing and nonfluoridelow-level, slow-release rate. Glass
caries rates
releasing materials.
ionomer restorative materials are
The purpose of this study was to
rechargeable in that they take up
surrounding glass
compare
the clinical performance
and re-release fluoride from
ionomer restorations
and recurrent caries associated with
fluoride-containing agents. The
in vivo.
two fluoride-releasing glass ionomer
recharging of fluoride-releasing
materials may be the most impormaterials and one nonfluoridetant factor in maintaining carioreleasing amalgam material used
static properties.7-9 Conventional glass ionomers
for Class III and V restorations in patients with a
and resin-modified glass ionomers have a welllow salivary flow rate who were instructed to use
documented protective effect against tooth demina topical fluoride daily. The initial hypothesis for
eralization in vitro.7,10-12 Although the exact level
this study was that no difference would be
of fluoride release required to protect against
detected in the recurrent caries rates adjacent to
caries has not been established, a dose-response
fluoride-releasing and nonfluoride-releasing
relationship has been demonstrated for fluoride.13
materials in any of the patients.
Conflicting information and controversy exist
MATERIALS AND METHODS
concerning the reduction in recurrent caries rates
7.14-17
surrounding glass ionomer restorations in vivo.
Three of us (C.H., J.S., J.B.) placed 111 restoraIn two surveys of general practitioners, Mjr14,15
tions in nine patients classified as xerostomic,
reported that the primary reason for the replacebased on subjective symptoms and a resting saliment of glass ionomer restorations was recurrent
vary flow rate of less than 0.2 milliliters/minute.
caries and that the recurrent caries rate for teeth
The subjects (seven women, two men) were
restored with glass ionomer restorations was no
recruited from The University of Texas Health
better than that for teeth restored with resinScience Center at San Antonio. We used rubber
based composite. McComb16 conducted a compredam isolation for all restorations. The fluoridehensive literature review of in vivo studies of
releasing materials used were Ketac-Fil Aplicap
caries prevention via fluoride-releasing restora(now marketed as Ketac-Fil Plus Aplicap)
tive materials and concluded that there is modest
(3M ESPE, St. Paul, Minn.) and Vitremer Core
evidence of a caries-controlling influence by glass
Buildup/Restorative (3M ESPE). The non
ionomer cements. In a similar review, Randall
fluoride-releasing material used was Tytin
R E S E A R C H
179
BOX
amalgam (Kerr, Orange, Calif.).
We placed and finished the
SCORING CRITERIA.*
restorations in one appointment
in accordance with the manufacSCORE
MARGINAL ADAPTATION
turers instructions. Tytin restorations were not polished. KetacThe restoration appeared to adapt closely to the surface of the
0
tooth, with no crevice formation. An explorer did not catch when
Fil restorations were finished
drawn across the margin or, if it did catch, only did so when
with Sof-Lex discs (3M ESPE)
passed in one direction.
and coated with light-cured
An explorer was lightly caught in both directions, and there
1
unfilled resin (Scotchbond Multiwas visible evidence of early crevice formation. Dentin was not
visible.
Purpose Dental Adhesive, 3M
ESPE). Vitremer restorations
An explorer was caught in both directions and penetrated a
2
marginal crevice. There was visible evidence of crevice formation;
were finished with Sof-Lex discs,
however, dentin was not visible.
but they were not coated with
A crevice was of sufficient depth to expose dentin. The
3
unfilled resin. The choice of
restoration required replacement.
restorative material was not
The restoration was fractured or lost.
4
entirely random in that amalgam
was not placed in the maxillary
ANATOMICAL FORM
anterior teeth. Otherwise, we
The restoration was continuous with the existing tooth anatomy.
0
used a coin flip to determine the
The restoration was not continuous with the existing tooth
1
restorative material to be used.
anatomy, but no dentin was exposed. The restoration was
Two of us (C.H., J.B.) evaluclinically acceptable.
ated the restorations at six
The restoration was not continuous with the existing tooth
2
months, one year and two years
anatomy and required replacement.
using scoring criteria similar to
CARIES IN ADJACENT TOOTH STRUCTURE
those described by Wood and col6
Caries was not present within 3 millimeters of the border of the
0
leagues (see box). At each evalurestoration.
ation, color slides and polyvinylCaries was present within 3 mm of the border of the restoration.
1
siloxane impressions were made
to aid in the evaluation process.
CARIES AT THE CAVOSURFACE MARGIN
At the beginning of the study,
No caries was present on a cavosurface margin.
0
we gave patients instructions on
Caries was present on a cavosurface margin.
1
oral hygiene and home care that
included the daily application of
* Adapted with permission of the publisher from Wood and colleagues.
fluoride gel (1.1 percent sodium
fluoride, pH 7.0) (PreviDent
RESULTS
brush-on gel, Colgate Oral Pharmaceuticals,
Canton, Mass.) via a custom-made tray or by
We evaluated 95 (86 percent) of the 111 restorabrushing it on. We assessed patient compliance
tions at the two-year recall appointment (Table
with these instructions during the study by
1). Table 2 shows the results expressed as the
recording the amount of fluoride gel used (that is,
percentage of restorations with the most favorwe recorded the number of tubes dispensed
able rating (score of 0) for each of the rating criduring the study) and at the end of the study by
teria. As shown in Tables 1 and 2, caries did not
questioning the patient. (Specifically, patients
develop at the cavosurface margin, or CSM, of 23
were asked how often they complied with the
(85 percent) of 27 Ketac-Fil restorations, 30
instructions to use the topical fluoride gel on a
(88 percent) of 34 Vitremer restorations and
daily basis.)
19 (56 percent) of 34 Tytin restorations.
At the completion of the study, we divided the
All of the restorations with caries at the CSM
patients into two groups: fluoride users (that is,
developed in the three patients who were less
those who were compliant at least 50 percent of
than 50 percent compliant with regard to the
the time) and fluoride nonusers (that is, those
daily use of fluoride gel. The cumulative findings
who were compliant less than 50 percent of the
for restorations with caries at the margin in these
time).
patients were as follows: four (36 percent) of 11
R E S E A R C H
TABLE 1
NO. OF RESTORATIONS
NO. OF
RESTORATIONS
Marginal
Adaptation
Rating*
AC Rating
Anatomical
Form Rating
CSM Rating
Ketac-Fil Aplicap
27
18
24
19
23
Vitremer
34
22
27
27
30
Tytin#
34
26
34
16
18
19
15
TABLE 2
Marginal
Adaptation
Anatomical
Form
AC*
CSM
Ketac-Fil Aplicap
67
89
70
85
Vitremer
65
79
79
88
Tytin
76
100
47
56
(P < .05). We rejected the hypothesis that no difference would be detected in recurrent caries
rates between fluoride-releasing and non
fluoride-releasing materials in any of the patients.
In regard to marginal integrity and anatomical
form, we found no statistically significant difference in the clinical success of the three restorative materials at the two-year recall appointment.
However, six (86 percent) of the seven glass
ionomer restorations (three Ketac-Fil and three
Vitremer) placed in a single patient exhibited surfaces that rapidly became severely eroded and
partially dissolved. These restorations required
replacement between six and 24 months after
R E S E A R C H
they were placed. No recurrent caries was associated with any of these seven restorations.
None of the other patients experienced a rapid
loss of surface material from the glass ionomer
restorations.
DISCUSSION
181
R E S E A R C H
TABLE 3
R E S E A R C H
183
R E S E A R C H
1998;26:591-7.
10. Gilmour AS, Edmunds DH, Newcombe RG. Prevalence and depth
of artificial caries-like lesions adjacent to cavities prepared in roots and
restored with a glass ionomer or a dentin-bonded composite material. J
Dent Res 1997;76:1854-61.
11. Nagamine M, Itota T, Torii Y, Irie M, Staninec M, Inoue K. Effect
of resin-modified glass ionomer cements on secondary caries. Am J
Dent 1997;10:173-8.
12. Eichmiller FC, Marjenhoff WA. Fluoride-releasing dental restorative materials. Oper Dent 1998;23:218-28.
13. Baysan A, Lynch E, Ellwood R, Davies R, Petersson L, Borsboom
P. Reversal of primary root caries using dentifrices containing 5,000
and 1,100 ppm fluoride. Caries Res 2001;35(1):41-6.
14. Mjr IA. Glass-ionomer cement restorations and secondary caries:
a preliminary report. Quintessence Int 1996;27:171-4.
15. Mjr IA. The reasons for replacement and the age of failed restorations in general dental practice. Acta Odontol Scand 1997;55:58-63.
16. McComb D. Caries prevention by fluoride-releasing restorative
materials: a review of in-vivo evidence. Proceedings of Conference on
Critical Reviews of Restorative Quandaries; October 1-3, 1998; Banff,
184