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Three restorative materials and topical

fluoride gel used in xerostomic patients: A


clinical comparison
CARL W. HAVEMAN, JAMES B. SUMMITT,
JOHN O. BURGESS and KAREN CARLSON
J Am Dent Assoc 2003;134;177-184

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erostomia, or dry mouth, is recognized as


having a pronounced adverse effect on the
incidence and risk of developing dental caries
because of the lost buffering capacity of the
saliva, reduced ions needed for remineralization and increased number of cariogenic
Fluoride- microorganisms. Although the precise
releasing salivary flow rate required to protect
teeth has not been determined, an
materials may
unstimulated flow rate of 0.2 millimereduce caries ters/minute or less is considered to be
surrounding below normal by public health
restorations researchers.1
in high-risk
BACKGROUND
patients who
When asked if they had noticed an
do not
increase in the number of patients who
routinely use have xerostomia, 87 percent of the
topical respondents to The Journal of the
fluoride. American Dental Associations Question
of the Month for August 2001 stated
that they had seen increases of 15 to 35
percent during the past couple of years.2 Multiple clinical
studies have shown the efficacy of using topical fluoride
gel on a daily basis to prevent caries in high-risk
patients.3-5 However, there is a paucity of in vivo evidence regarding the effect of fluoride-releasing restorative materials in patients at high risk of developing
caries. In vivo studies comparing the daily use of topical
fluoride with the effect of fluoride-releasing materials on
the incidence of caries in high-risk patients are

CARL W. HAVEMAN, D.D.S., M.S.; JAMES B.


SUMMITT, D.D.S., M.S.; JOHN O. BURGESS, D.D.S.,
M.S.; KAREN CARLSON, B.S.

A clinical comparison

Background. The authors compare the


incidence of recurrent caries
around two glass ionomer
A D A
J
restorative materials and

one amalgam material.


Methods. The authors
placed 111 restorations in
N
C
nine xerostomic patients. A U I N G E D U
2
R
Patients were given oral
TICLE
hygiene instructions and fluoride
gel to use daily. The authors evaluated the
restorations clinically and with photographs and impressions at six months, one
year and two years according to criteria for
marginal adaptation, anatomical form,
caries in adjacent tooth structure and caries
at the cavosurface margin. The authors
divided patients into users and nonusers of
fluoride.
Results. At the two-year recall appointments, the authors evaluated 95 (86 percent) of the 111 restorations. They analyzed
two-year data using an analysis of variance
for repeated measures and Fishers post hoc
test. The study results showed no significant differences among materials in regard
to caries at the cavosurface margin among
fluoride users. However, among fluoride
nonusers, patients with amalgam restorations had a significantly higher incidence of
caries at the cavosurface margins than did
patients with either of the two glass
ionomer restorations. The authors found no
statistically significant difference between
restorations with regard to marginal
integrity or anatomical form. However, one
patient exhibited failure of glass ionomer
restorations owing to material loss.
Conclusions. Less caries developed at
the margins of glass ionomer restorations
compared with amalgam restorations in
xerostomic patients who did not routinely
use a neutral topical sodium fluoride gel.
Clinical Implications. Fluoridereleasing materials may reduce caries surrounding restorations in high-risk patients
who do not routinely use topical fluoride.
Patients who routinely used topical fluoride
gel did not develop recurrent caries, and
clinicians should encourage the use of fluoride gel on a daily basis.
CON

Three restorative
materials and topical
fluoride gel used in
xerostomic patients

ABSTRACT

IO
N

R E S E A R C H

178

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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

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179

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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

RESULTS AT TWO-YEAR RECALL APPOINTMENTS.


RESTORATIVE
MATERIAL

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

TWO-YEAR RESULTS EXPRESSED AS PERCENTAGE OF RESTORATIONS


WITH MOST-FAVORABLE RATING.
RESTORATIVE
MATERIAL

PERCENTAGE OF RESTORATIONS WITH SCORE OF 0

Marginal
Adaptation

Anatomical
Form

AC*

CSM

Ketac-Fil Aplicap

67

89

70

85

Vitremer

65

79

79

88

Tytin

76

100

47

56

* AC: Caries in adjacent tooth structure.


CSM: Caries at the cavosurface margin.
Ketac-Fil Aplicap (now marketed as Ketac-Fil Plus Aplicap) glass ionomer is manufactured by 3M ESPE, St. Paul, Minn.
Vitremer Core Buildup/Restorative glass ionomer is manufactured by 3M ESPE.
Tytin amalgam is manufactured by Kerr, Orange, Calif.

Ketac-Fil restorations, four (27 percent) of 15


Vitremer restorations and 15 (68 percent) of 22
Tytin restorations. None of the patients who complied with the daily use of fluoride gel had restorations with caries at the CSM.
We analyzed two-year data using analysis of
variance for repeated measures and a Fisher post
hoc test. This analysis revealed a significant difference between materials regarding caries at the
CSM in patients who were less than 50 percent
compliant with the daily use of fluoride gel.
Patients with the glass ionomer restorations had
a significantly lower rate of caries at the CSM
than did patients with amalgam restorations
180

(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

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* See the box for scoring criteria.


AC: Caries in adjacent tooth structure.
CSM: Caries at the cavosurface margin.
Ketac-Fil Aplicap (now marketed as Ketac-Fil Plus Aplicap) glass ionomer is manufactured by 3M ESPE, St. Paul, Minn.
Vitremer Core Buildup/Restorative glass ionomer is manufactured by 3M ESPE.
# Tytin amalgam is manufactured by Kerr, Orange, Calif.

R E S E A R C H

Figure 2. Glass ionomer restoration (Vitremer Core


Buildup/Restorative, 3M ESPE, St. Paul, Minn.) in the
mesiolingual aspect of tooth no. 7 at baseline in patient
no. 1.

Figure 3. The same restoration as in Figure 2, 13 months


after placement.

Figure 4. The same restoration as in Figure 2, 17 months


after placement.

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.

caries-protective effect of the restoration.


Figure 1 also shows amalgam restorations in
teeth nos. 28 and 29, with caries involving the
margins of both restorations, indicating a lack of
caries-protective effect. Caries was present at the
margin of one (9 percent) of the 11 fluoridereleasing glass ionomer restorations placed in
this patient, whereas caries involving the margins was evident for four (67 percent) of six
amalgam restorations.
Patient no. 1 also had received radiation
therapy for head and neck cancer and was poorly
compliant with regard to the use of fluoride gel
(that is, less than 50 percent of the daily applications). This patient refused to stop the frequent
daily consumption of a sugar-containing soft
drink as the primary means of moistening the

DISCUSSION

Patient no. 6, who had received radiation therapy


for head and neck cancer, refused to use the topical fluoride and perform basic oral hygiene. This
patient agreed to return to the clinic for the
evaluation appointments, but refused to undergo
routine care. Figure 1 shows Vitremer restorations in teeth nos. 26 and 27 two years after
placement. Although a large amount of caries is
present in these teeth, the caries does not involve
the margins of the restorations, which indicates a

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181

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Figure 1. Glass ionomer restorations (Vitremer Core


Buildup/Restorative, 3M ESPE, St. Paul, Minn.) in teeth
nos. 26 and 27 and amalgam restorations (Tytin, Kerr,
Orange, Calif.) in teeth nos. 28 and 29 two years after
placement in patient no. 6.

R E S E A R C H

TABLE 3

restoration involved the margin.


This sequence of photographs
reveals that the cariostatic effect of this fluoridereleasing restorative material is limited and can
be overwhelmed by a rapidly progressive caries
process.
Glass ionomer restorations provided a greater
in vivo cariostatic effect than did amalgam restorations in patients at high risk of developing
caries. After two years, four (15 percent) of 27
182

in these studies is that there was a


dose-response relationship between
fluoride use and caries incidence.
We are concerned about the survivability of
glass ionomer restorations in a dry mouth. However, a large majority of the glass ionomer restorations in this study did not experience rapid
material failure leading to poor marginal adaptation or poor anatomical form, as did occur in the
study by Wood and colleagues.6 Although a small

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Ketac-Fil restorations, four


PATIENT DATA.
(12 percent) of
34 Vitremer
PATIENT
RESTING
USE OF TOPICAL
MISCELLANEOUS
RECURRENT
restorations
NO.
SALIVARY FLOW
FLUORIDE
FACTORS
CARIES RATE
RATE
GEL
and 15 (44
percent) of 34
High
Consume soft
1
Occasionally
< 0.1
drinks daily
Milliliter/minute
Tytin restorations were
Low
0.05% sodium
2
Never
Negligible
fluoride rinse
associated
with caries at
None
None
3
Four times per
0.2 mL/minute
week
the CSM.
These findings
None
None
4
Daily
Negligible
are similar to
None
None
5
Daily
< 0.1 mL/minute
those of Qvist
High
Never brushed
6
Never
0.2 mL/minute
and colleagues,18 who
None
Used oral
7
Daily
< 0.1 mL/minute
moisturizer daily
reported that
after three
None
None
8
Four times per
Negligible
week
years, caries
progression in
None
None
9
Daily
< 0.1 mL/minute
primary teeth
involved 21
mouth. Although we provided repeated instrucpercent of amalgam restorations compared with
tions in the proper use of fluoride gel and in oral
12 percent of glass ionomer restorations.
hygiene methods, the patient was poorly comOur findings also support those of Donly and
pliant and had a high appointment failure rate.
colleagues,19 who found that resin-modified glass
Caries was present at the margins of six (54 perionomer restorations can help prevent enamel
cent) of 11 glass ionomer restorations and at the
demineralization on adjacent teeth.
margins of 11 (79 percent) of 14 amalgam
It is important to note that the six patients in
restorations.
our study who were at least 50 percent compliant
Figure 2 shows a Vitremer reswith regard to the daily use of fluotoration in the mesiolingual aspect
ride gel exhibited no caries within 3
of tooth no. 7 at baseline in patient
mm of the margins of their 47 restoGlass ionomer
no. 1. Figure 3 shows the same
rations in all. However, we did not
restorations provided assess the presence of caries elserestoration 13 months later.
a greater in vivo
Caries was present within
where in the restored teeth or in
cariostatic effect than other teeth. The results of this study
3 mm of the restoration, but did
not involve the margin. Figure 4
support those of Wood and coldid amalgam
shows this restoration 17 months
leagues6 and those of other studies3-5
restorations in
after placement. Rapid caries prothat demonstrated the efficacy of
patients at high risk
gression has occurred, and the
using topical fluoride gels daily to
of developing caries.
caries adjacent to the Vitremer
prevent caries. The primary finding

R E S E A R C H

Dr. Summitt is a professor and chairman,


Department of Restorative Dentistry, The University of Texas Health
Science Center at San
Antonio.

Dr. Burgess is a professor and chairman,


Department of Operative Dentistry and Biomaterials, Louisiana
State University Health
Science Center, School
of Dentistry, New
Orleans.

Ms. Carlson is a dental


assistant, Division of
Clinical Research, The
University of Texas
Health Science Center
at San Antonio.

dietary products may have played a role.


CONCLUSIONS

The results of our study show that significantly


less caries developed at the CSM of the fluoridereleasing glass ionomer restorative materials
(Ketac-Fil and Vitremer) compared with amalgam
(Tytin) in patients who were less than 50 percent
compliant with regard to the daily use of topical
neutral sodium fluoride gel. No caries developed
within 3 mm of the restorations in patients who
were compliant at least 50 percent of the time
with regard to the daily use of sodium fluoride
gel. The glass ionomer restorations did not
undergo a high failure rate as a result of severe
surface degradation.
The authors gratefully acknowledge that this project was funded
in part by grant UR6648-21 from the 3M Company, St. Paul,
Minn.

1. Dodds M, Suddick R. Caries risk assessment for determination of


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3. Horiot JC, Schraub S, Bone MC, et al. Dental preservation in
patients irradiated for head and neck tumours: a 10-year experience
with topical fluoride and a randomized trial between two fluoridation
methods. Radiother Oncol 1983;1:77-82.
4. Jansma J, Vissink A, Gravenmade EJ, Visch LL, Fidler V, Retief
DH. In vivo study on the prevention of postradiation caries. Caries Res
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6. Wood RE, Maxymiw WG, McComb D. A clinical comparison of
glass ionomer (polyalkenoate) and sliver amalgam restorations in the
treatment of class 5 caries in xerostomic head and neck cancer
patients. Oper Dent 1993;18:94-102.
7. Burgess JO. Fluoride-releasing materials: a critical review of in
vitro anti-caries effects. Proceedings of Conference on Critical Reviews
of Restorative Quandaries; October 1-3, 1998; Banff, Calgary, Canada.
Transactions 1998;12:151-76.
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JADA, Vol. 134, February 2003


Copyright 2003 American Dental Association. All rights reserved.

183

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percentage of glass ionomer restorations failed as a result of loss


of surface material (three [9 percent] of 32 Ketac-Fil restorations
were replaced after six to 12
months and three [9 percent] of
Dr. Haveman is an
34 Vitremer restorations failed
associate professor,
after 12 to 24 months), all of
Department of General
Dentistry, The Univerthese failures occurred in a
sity of Texas Health
single patient (patient no. 7). The Science Center at San
Antonio, 7703 Floyd
rapid surface loss that occurred
Curl Drive, San
in these restorations is similar to Antonio, Texas 78229,
e-mail haveman@
that seen by Wood and coluthscsa.edu. Address
leagues,6 who reported dissolureprint requests to Dr.
tion of 32 (91 percent) of 35 glass Haveman.
ionomer restorations in patients
who used a topical fluoride gel with a pH of 5.8 on
a daily basis.
Table 3 shows pertinent data for each patient.
Patient no. 7 was severely xerostomic and used
the fluoride gel daily. Although it is possible that
the fluoride gel contributed to the rapid surface
degradation of the glass ionomer materials, this is
unlikely because patients 4, 5 and 9 also were
very xerostomic and complied with regard to the
daily use of fluoride. None of the glass ionomer
restorations in these patients exhibited surface
degradation.
Table 3 also shows that the resting salivary
flow rate of seven (78 percent) of the nine patients
was less than 0.1 mL/minute. Researchers have
shown that dehydration damages glass ionomer
material20,21; however, only patient no. 7 experienced a rapid loss of material from the glass
ionomer restoration surface. This patient used an
oral moisturizing agent several times daily to
reduce the symptoms of dry mouth. The manufacturer of this moisturizing agent reported that the
product (when added to water) had a pH of 5.5 to
6.5 (Laclede, Rancho Dominguez, Calif., oral and
written communication, August 2001), which is
similar to the pH (5.8) of the sodium fluoride used
in the study by Wood and colleagues.6
The 86 percent failure rate (six of seven glass
ionomer restorations) in patient no. 7 also is similar to the 91 percent failure rate reported in the
study by Wood and colleagues.6 Because it is
known that an acidic environment adversely
affects glass ionomer restorations,22 the frequent
use of the slightly acidic oral moisturizing agent
may have caused the loss of material from restorations placed in patient no. 7. In addition, other
factors such as vigorous tooth brushing or acidic

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.
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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
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