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Contact Dermatitis 2009: 61: 313–319
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© 2009 John Wiley & Sons A/S
CONTACT DERMATITIS
Reactions to resin-based dental materials in
patients–type, time to onset, duration, and
consequence of the reaction
ANDERS TILLBERG1 , BERNDT STENBERG2 AND ANDERS BERGLUND3
1 Faculty of Medicine, Institute of Clinical Dentistry, University of Tromsø/Public Dental Service Competence Centre of
Northern Norway, Tromsø, Norway, 2 Faculty of Medicine, Department of Public Health and Clinical Medicine, and
3 Faculty of Medicine, Department of Odontology, Umeå University, Umeå, Sweden
Objective: The aim of the present study was to determine the types of side-effects occurring and for
how long they lasted in a group of patients with side-effects assessed to be caused by resin-based
materials.
Methods: A total of 618 reports were received by the Swedish National Register of Side-Effects to
Dental Materials, among which 36 were on patients with reactions assessed to be caused by resin-based
restorative materials. The group examined consisted of 25 women and 11 men, with a mean age of
47.8 ± 15.6 years. A follow-up was done through a structured telephone interview.
Results: The majority of symptoms were intra-oral or a combination of intra-oral and extra-oral symptoms
that appeared within the first 24 hr after treatment. The most common adverse effects reported were skin
problems, oral ulcers, and burning mouth. Within less than a week, the reactions had disappeared in 50%
of the patients.
Conclusion: Immediate reactions to resin-based materials were more prevalent than delayed allergic
reactions, and the mechanism of the immediate reactions is probably non-allergic in most cases. There is
a need for developing provocation tests to verify the association between the reaction and the material,
and also to identify the offending component.
Key words: adverse effects; allergy; dental materials; resin-based materials. © John Wiley & Sons
A/S, 2009.
Accepted for publication 29 April 2009
In recent years, both scientific institutions and the
general public have shown great interest in the possible side-effects from a number of dental materials.
The prevalence of side-effects from dental materials is considered to be low in relation to the vast
number of dental treatments undertaken and vary
with the type of treatment (1, 2). There is, however, a lack of data concerning the frequency and the
type of such side-effects. The reporting schemes in
Scandinavia present the best estimates, which suggest that some sort of adverse reaction may occur
in 1 in 700 to 1 in 2600 dental procedures (3–6).
Since the exact number of persons exposed is not
known, the magnitude of reactions is difficult to estimate. Complexities in analysing the reports on sideeffects from dental materials have also undoubtedly
contributed to the absence of reliable data concerning the frequency of side-effects.
Epidemiological data suggest that the majority of
side-effects from dental resins are allergic contact
in nature (7). Among dental professionals, allergic
contact dermatitis has been studied in a number of
papers (8–11). However, published information on
contact allergy in patients has mainly been based
on case reports (12–18). In 1996, the Swedish
National Board of Health and Welfare established
a register on the side-effects of dental materials
where reports were received from dentists, dental
hygienist, and physicians. Since the register is a
compilation of information on many patients,
it enables analysis on more than individual case
reports.
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TILLBERG ET AL.
The aim of the present study was to describe the
type and duration of side-effects that occurred as
well as treatment and long-term consequences in a
group of patients with side-effects assessed to be
caused by resin-based materials for direct dental
restorations.
Contact Dermatitis 2009: 61: 313–319
Patch test
Altogether eight patients had
test according to the Dental
(Chemotechnique® Diagnostics,
www.chemotechnique.se) used
clinics in Sweden.
undergone patch
Screening Series
Vellinge, Sweden;
at Dermatology
Materials and Methods
The Swedish Register of Side-Effects of Dental
Materials
The Swedish National Board of Health and Welfares Register of Side-Effects of Dental Materials was established in Sweden in 1996 to monitor
and evaluate adverse reaction from dental materials. This register was set up in collaboration with
Medical-Odontological faculty of the University of
Umeå, Sweden. As a similar reporting procedure
had been in function since 1993 at the University of Bergen, Norway (19, 20), the Swedish unit
exchanged experiences with the Norwegian unit.
The Swedish National Board of Health and Welfares Register of Side-Effects of Dental Materials
was phased out in 2002.
Selection of study objects
A total of 618 reports were received by the
National Register of Side-Effects from 1996 to
1999, among which 456 reports were on patients
and 162 on dental practitioners. Among the patients,
15% reported complaints in connection with treatment with composite and bonding materials. Specialists from the Department of Dental Materials
Science, Faculty of Odontology, Umeå University,
evaluated the reported reactions in collaboration
with medical experts from occupational and environmental medicine and dermatology. The connection between the material and the reaction was
assessed as ‘Probable’, ‘Possible’, ‘Uncertain’, or
‘Unclassifiable’, depending on the probability of the
relationship and on the quality of information submitted by the reporter.
A report was classified as ‘Probable’ when the
reaction was well known, the investigation of the
patient was complete, and no alternative explanation
was feasible. When the investigation was insufficient but the reaction was well known and a time
correlation could be established between treatment
and reaction, then the classification ‘Possible’ was
used because a relation could not be excluded.
The inclusion criteria for the patients participating
in the study were that they should have:
(1) reactions suspected to be caused by resin-based
materials for direct dental restorations;
(2) reactions that the Side-Effects Registers Expert
group had assessed to be ‘Probable’ or ‘Possible’; and
(3) reactions occurring during the years 1996–1999.
Telephone interview
The patients (n = 36) who fulfilled the inclusion
criteria were examined via a telephone interview
with pre-determined questions (Fact Box 1) developed in collaboration with the Side-Effect Registers Expert group. The mean follow-up time
between the report to the register and the telephone
interview was 17 months (range 4–32 months).
All 36 patients participated in the telephone
interview.
Fact Box 1. The content of the questionnaire (telephone interview)
Background variables
Marital status, number of children, education,
type of work, contact with chemicals (epoxy and
isocyanate), current employment situation, and
work demands
Remaining problems (symptoms) at follow-up
Intra-oral symptoms: e.g. burning mouth, dry
mouth, increased salivation, taste disorder, pain
from temporomandibular joint, and stiffness/
numbness
General symptoms: e.g. fatigue, headache, nausea, anxiety, depression, sleeping problems, vertigo, eye symptoms, skin symptoms, circulatory
symptoms, and muscular and joint problems
Consequences for the future
Dental treatment, avoidance of plastics, etc.
Consequences for work-related issues
Stopped working, change of working capacity
(work hours, sick leave, disability pension, early
retirement pension)
Diseases of importance for the patients’
symptoms
Asthma, hay fever, eczema, and atopy
Reactions in connection with replacement
Type of reaction
Examination performed by
Dentists, medical doctor (general practioner or
specialist), complimentary care
Action taken due to symptoms
No action, removal of dental restorations, and
medication
Contact Dermatitis 2009: 61: 313–319
REACTIONS TO RESIN-BASED DENTAL MATERIALS
Ethical considerations
The study was approved by the Ethics Committee of the Faculty of Medicine and Odontology,
Umeå University.
Information obtained from the register with
complimentary addition through the telephone
interview
Time between treatment and symptom alleviation.
The reactions disappeared within less than a week
for more than half of the patients. In 25% of the
patients, the symptoms remaining after 18 months
(Table 4) were in all cases local, e.g. irritation and
ulcers, unspecified intra-oral problems; pain from
the gingiva that spread up through the nostrils;
blisters on the tongue and lips; difficulties in eating
and swallowing due to blisters and a stinging,
burning sensation intra-orally.
Consequences of the reactions. In 12 cases, the
reported reactions have not had any consequences,
but in 11 cases the patients had avoided restoring
their teeth again with the same material. Furthermore, in eight cases, the patients had the material
removed while four of the patients had not dared to
go to the dentist after the reaction, which took place
more than 1 year before the telephone interview. In
one case, the patient had visited the dentist but did
not allow the dentist to restore her cavities because
she was afraid of new reactions.
History of atopy and reported health problems.
Three patients had had a test-verified atopic illness.
Eight patients had or have had asthma before the
reported reactions, and six patients had had hay
fever. One patient had suffered food allergy caused
by milk, egg fish, and hazelnuts. Ten of the patients
reported that they had had eczema, six of them had
undergone a patch test that verified contact allergy
(not to resin-based materials) before the reported
reaction. The allergens were nickel, chromate, and
gold.
Affection of the working capacity. In 26 cases, the
patients were fully capable of working. However,
in one case, the patient stated that he had been
incapable of working for 9 months due to intraoral problems, e.g. burning mouth and ulcers that he
related to his dental restorative material. In another
case, a dental assistant was unable to work since
she could not stay in the dental clinic mainly due
to respiratory problems. A further 5 of the patients
were senior citizens and 3 were prematurely retired
because of disabilities unrelated to their dental
materials.
Sick leave related to dental materials. Of the 36
patients studied, 30 had not been on any sick leave
due to the reactions. Three patients had been on
sick leave for 2 weeks or less and a further three
between 9 and 28 months. One of the patients was
still on sick leave after 28 months due to difficulties
in eating and swallowing. None of the 36 patients
had been forced to retire prematurely because of the
reported health problems.
Results
Information obtained from the register
The group interviewed consisted of 25 women and
11 men, with a mean age of 47.8 ± 15.6 years
(range 8–73). The connection between the material
and the reaction was assessed by the Side-Effect
Registers Expert group as ‘Probable’ in 13 patients
and as ‘Possible’ in 23 patients.
The most frequently reported materials suspected
to be causing the reactions are listed in Table 1.
The types of the symptoms and signs, and time
between treatment and reactions
The locations of the symptoms experienced by the
patients together with the point of time of the first
appearance of the symptoms are given in Fig. 1.
Among those cases with intra-oral symptoms and
signs, necrosis of the oral mucosa and a stinging,
burning sensation in mouth were most frequently
reported. Among the extra-oral symptoms and signs,
skin reactions, e.g. rash and itching, were reported
in 10 cases (Table 2).
Most of the reactions (83%, n = 30) occurred
within the first 24 hr after treatment of which almost
two-third of the cases (n = 19) reacted during dental
treatment (Fig. 1). A patient who had an immediate
skin reaction after exposure to a temporary crown
and bridge material is shown in Fig. 2.
Action taken due to symptoms
In most of the cases, no action was taken due to the
symptoms (Table 3).
Table 1. Materials suspected to cause the reactions
Reported material
n
Primer, bonding, and composite resin
Primer and bonding
Primer
Composite resin
Composite cement for crown and bridges
Etching gel
Composite resin and amalgam
Fluoride varnish, etching gel, and fissure sealant
Primer, bonding, composite, and temporary cement
Material for temporary crowns
14
12
1
1
2
2
1
1
1
1
More than one material is reported.
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TILLBERG ET AL.
Contact Dermatitis 2009: 61: 313–319
Fig. 1. Distribution of 36 patients stratified by the location of symptoms, time to onset of the symptoms, and result of patch test
(Dental Screening Series, Sweden).
Table 2. Type of symptoms and signs
Symptom
Intra oral
Intra-oral sores
Burning mouth
Necrosis of the oral mucosa
Swelling of the lips, oral cavity, and throat
Extra oral
Skin problem (rash and itching)
Swelling of the face
Extra-oral symptoms, not mentioned above*
Asthmatic reactions
Extra-oral sores
n
7
7
5
4
10
7
5
4
2
More than one symptom is reported.
Fig. 2. A patient who has just received a temporary bridge.
Urticaria occurred on her arms and neck.
Work-related exposures to chemicals. Seven of the
patients examined reported that they were, or had
been, occupationally exposed to chemicals in acrylates. The chemicals were, among others, developing
liquids for photographs and plastics used to cover
pictures, epoxy resins for sealing floors, composite resins, and solvents in dental clinics. Three of
∗ Headache, anxiety, difficulties in concentrating, vertigo, fatigue,
palpitation, pain from muscles and joints.
the patients reported that they were working with
acrylates; a printmaker, a painter, and a dental assistant, whereas two of the patients reported that they
were working with epoxy resin; a painter and a construction worker. The latter was tested and not found
to be allergic to epoxy resin.
Referrals or treatment after the reported reaction.
Dentists had examined 5 of the patients, and
Contact Dermatitis 2009: 61: 313–319
REACTIONS TO RESIN-BASED DENTAL MATERIALS
Table 3. Action taken due to symptoms (n = 36)
bias, which may either enhance or impair the recall
of memory. However, self-generated information
will be better remembered than, e.g. information
that is simply readable, in cognitive science this is
referred to the so-called generation effect. Therefore, the information obtained from the register
combined with the information from the telephone
interview will give a sufficient description of the
patients’ situation.
Methacrylic compounds are nowadays widely
used in restorative dentistry, and composite resin
restorations have almost completely replaced by
amalgam fillings in Scandinavia (7). The acrylic
content of dental composites poses a risk for adverse
reactions. Although the quantities of the substances
released are probably too small to cause systemic
reactions, local skin or mucosal reactions may arise
from direct contact with dental composites (21).
It is often difficult to assess side-effects since the
quality of the information in the material safety
data sheet (MSDS) is often insufficient and may
in some cases be incorrect (22–25). Moreover,
MSDS do not need to specify components in low
concentrations, which could be relevant to, e.g.
allergic reactions. It has been suggested that a more
stringent control of the risks with dental materials
would be of importance from the patients’ and
dental practioners’ point of view (26).
Documented incidents of adverse reactions in
patients caused by resin-based materials in dentistry
are quite rare, despite of their extensive use. Underreporting is suspected to be high (27) which in
turn leads to incidence figures that are unreliable.
The problem has been recognized by van Noort
et al. (27) who suggested that a pro-active reporting
system should be established even if it takes time to
generate useful information.
When side-effects of dental materials are discussed, it must be clear whether they refer to patients
or to dental practitioners. In a report from the
Swedish National Board of Health and Welfares
Register of Side-Effects from Dental Materials, it
was reported that patients and dental practitioners
reacted to different dental materials (28). A conceivable explanation for this is that the exposure
is different between the groups. The practitioners
are handling the materials when they are in their
most reactive phase, whereas the patients often are
exposed to set materials. Moreover, the relevance of
a positive patch-test reaction to a substance in the
dental screening series is not always easy to assess,
and the symptoms might also be caused by other
sources than dental materials. In addition to the dental screening series, tests with other substances must
be considered for testing.
In the present study, 13 reports dealt with primer
and bonding, non-cured products that in in vitro
Action taken
n
No treatment
Removal of dental materials
Corticosteroid treatment (one topical and three systemic)
Antihistamine tablets
Chlorhexidine (mouth rinse)
Stopped working (dental nurse)
Attended to hospital
19
8
4
2
1
1
1
Table 4. Time between treatment and symptom alleviation
(n = 36)
Time
n
Disappeared in less than a week after treatment
Disappeared between 1 and 2 weeks after treatment
Symptom still present after 18 months
19
8
9
specialists within medicine had examined 8 of
the patients. Eight patients had been patch tested
(Fig. 1). Furthermore, only 3 patients showed allergic type IV reactions to resin-based materials (1,
non-rigid plastic; 2, methylmethacrylate, ethylenglycol dimethacrylate, hydroxyethyl methacrylate,
dimethylaminoethyl methacrylate, and tethrahydrofurfuryl methacrylate; 3, methylmethacrylate). One
of the 36 patients had been seeking treatment within
the field of ‘alternative medicine’.
Discussion
In the present study, it was found that the majority of symptoms suspected to have been caused by
resin-based materials were intra-oral or a combination of intra-oral and extra-oral symptoms that
appeared within the first 24 hr after treatment. The
most common adverse effects reported were skin
problems, oral ulcers, and burning mouth. Within
less than a week, the reactions disappeared in half
of the patients, and in an equal number of patients
no actions were taken due to the symptoms. Four of
the patients had avoided visiting the dentist again
after the reaction.
This study was relatively extensive in comparison to earlier studies that were mainly based on
case reports. The consistency in the answers to the
telephone interviews is considered to be high since
a protocol with pre-determined questions was used
for all patients. The majority of symptoms appeared
during treatment or at least within the first day,
which indicates the need for new examination routines. However, it would have been desirable if all
patients had been examined by a specialist in dermatology, which would have increased the credibility of the information given by the patients. The
follow-up time between the reported symptoms and
telephone interview must be taken under consideration because it might have introduced memory
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studies (29, 30) have shown to have a cytotoxic
potential. Lönnroth et al. (30) have shown that the
liquid component in resin products has a strong
irritation capacity. Most of these reactions can be
avoided by observing precautions such as following safe handling procedures and practices for dental practitioners that handle non-cured polymers
manually (17).
The most common adverse effects reported were
skin problems and contact dermatitis, which is in
line with earlier findings (7). In the present study,
the most frequent oral manifestations included intraoral ulcers, swollen lips, and respiratory reactions
such as swollen throat and asthma; the latter also
has been reported to be common among dental
practitioners (31). Burning mouth was reported in
20% of the patients (n = 7) but the role of contact allergy in the pathogenesis of burning mouth
syndrome is unclear (32). The aetiology of burning mouth has also been suggested to be multifactorial with several local and systemic aetiological
factors such as xerostomia, iron deficiency, lack
of B-vitamins, and diabetes. Pharmaceuticals, e.g.
levothyroxin and antihypertensive drugs, can also
be associated with burning mouth (33, 34). Furthermore, depression and anxiety have frequently been
reported among patients with burning mouth, which
indicates that psychosomatic components may be
involved (33, 35).
Dental treatment involves the use of a wide
range of materials. There are different clinical
presentations of contact allergy to dental materials intra-orally but this entity is still not fully
understood (36). Moreover, psychological stress
has been reported to have a negative effect on wound
healing of the oral mucosa which supports the idea
that psychological strain plays an important role as
an aetiological factor in the reactions of the oral
mucosa (37, 38).
Seven patients in the present study reported a
work-related exposure to plastic before the symptoms appeared. Since none of these patients were
verified as allergic to plastic, it is not likely that this
exposure could explain the patients’ symptoms.
Case reports (15–17) have shown that most reactions occurred during or close after insertion of the
dental filling material. Almost 90% of the patient in
the present study reported a similar reaction pattern. An immediate reaction is usually a type I
reaction if the reaction is confirmed as allergic.
Normally, the allergen is a protein/polypeptide like
those found in latex products. This type of reaction affects above all atopic patients. Atopic patients
were not over-represented among those with immediate reactions, and proteins are not a part of the
content in composites. This observation indicates
a non-allergic background for the reactions. There
Contact Dermatitis 2009: 61: 313–319
are, however, exceptions from this ‘protein rule’.
It has been reported that isocyanate and formaldehyde can cause IgE sensitization (39, 40), and
this can occur also in previously non-atopic persons. It should be further investigated whether there
are IgE-mediated reactions to composite materials.
This should be investigated. More difficult but perhaps more urgent is the development of provocation tests to establish a relationship between the
materials and reactions when it is of a non-allergic
nature.
Conclusion
Immediate reactions to resin-based materials were
more prevalent than delayed allergic reactions, and
the mechanism of the immediate reactions is probably non-allergic in most cases. The mechanism of
the immediate reactions should be further studied.
Because of a lack of relevant provocation tests,
we still have had great difficulties in verifying the
association between the reaction and the material
and also to identify the offending component when
the mechanism is non-allergic. This is an important
future research issue.
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Address:
Anders Tillberg, DDS, PhD
Faculty of Medicine
Institute of Clinical Dentistry
University of Tromsø
9018 Tromsø
Norway
Tel: +47 776 49131
Fax: +47 776 49101
e-mail: [email protected]