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Endodontic material

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DOI: 10.1177/08959374880020010301

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in Dental Research

Endodontic Materials
D. Ørstavik
ADR 1988 2: 12
DOI: 10.1177/08959374880020010301

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 ENDODONTIC MATERIALS
D . 0RSTAVIK
NIOM — Scandinavian Institute of Dental Materials, Kirkeveien 71B, N-1344 Haslum, Norway

Adv Dent Res 2(l):12-24, August, 1988

ABSTRACT

ndodontic sealing materials for permanent obturation of root canals are highly variable both in chem-
E istry of setting and in their additives. Conventional materials are based on zinc oxide-eugenol, rosin-
chloroform, or synthetic resins. These have been extensively tested for biological and technical properties. Most
materials are slightly or moderately cytotoxic, and some — notably paraformaldehyde-containing materials —
have been associated with clinical complications such as paresthesia of the mental and/or inferior alveolar nerve.
Recently, Ca(OH)2-containing materials have been introduced with claims of improved clinical and biological
performance. However, there is little documentation of the alleged benefits of new materials.
The virtual absence of comparative clinical studies on endodontic filling materials appears to be the major
obstacle to critical assessment of old materials or to adequate documentation of new formulae. A recently
introduced scoring system for the radiographic assessment of apical periodontitis may aid in the future testing
of endodontic materials. Results with this scoring system on extensive clinical material indicate that it is possible
to discriminate among endodontic materials with small differences in clinical performance.

INTRODUCTION

Endodontic materials are used for permanent ob-

turation of root canals after cleansing, shaping, irri-
gation, and medication. Materials for obturation come
either as (1) core and sealer combinations, (2) plasti-
cized gutta percha, or (3) setting or non-setting pastes
(Fig. 1). The most frequently used cores are made of
gutta percha, an isoprene polymer, with additions of
heavy metal oxides, primarily zinc oxide. Alterna-
tively, metal points have been used. The sealers and
pastes are of widely different compositions, but most
of them fall into one of the four categories shown in
Table 1. A B C
Both the physical and biological properties of en- Fig. 1—Principles of root fillings. A, solid core (c) and sealer (s);
dodontic materials are dependent on their chemical B, softened gutta-percha (in this situation softened by compaction);
composition. As an illustration of the great diversity C, paste-type material applied with spiral filler.
in chemistry and composition of these materials, Ta-
ble 2 lists the ingredients and mechanism of setting
of some commonly used products. This diversity stems
from the fact that several different properties have chloroform formulations were developed to soften the
been considered important for the clinical perform- surface of the gutta-percha point, thereby improving
ance of the materials. Thus, zinc oxide-eugenol seal- the adaptation of the point to the root canal wall.
Additions of paraformaldehyde or other antibacterial
ers have been developed with emphasis on sealing agents to zinc oxide-eugenol sealers were done by
qualities of this cement base, preventing ingress of endodontists relying on antisepsis for treatment. In
saliva and bacteria through the root canal. Rosin- contrast, omission of such toxic substances is sought
Presented at the International State-of-the-Art Conference on Re- by researchers who emphasize the biocompatibility
storative Dental Materials, September 8-10, 1986, National Insti- aspects of the materials. Synthetic resins have been
tute of Dental Research introduced with minimal shrinkage, or slight expan-
12

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Vol. 2 No. 1
TABLE 1
CATEGORIES OF ENDODONTIC SEALERS
Type
Examples
Zinc oxide-eugenol Rickert's, Grossman's, N2, En-
domethasone, CRCS
Non-eugenol sealers Diaket, Sealapex, Nogenol
Polymeric resins Hydron, AH 26, Traitement
SPAD
Rosin-based sealers Callahan's sol., Chloropercha,
rosin-chloroform
sion, on setting as an advantage. Recently, materials
containing calcium hydroxide have been introduced
which purportedly aid in the healing of apical peri-
odontitis, extending the philosophy of the resorbable
pastes which were to perform pharmaceutical func-
tions in the periapical area.
The gutta-percha points rely on their flexibility and
adaptability for their success; in sharp contrast, the
metal points were used when rigidity was considered
important for the placement of a root filling in narrow
and curved canals.
While endodontic treatment in general is a reliable
clinical procedure with a predictably high frequency
of success (Table 3), the use of endodontic materials
often presents clinical problems. Traditionally, long-
term stability and sealing properties of the endodon-
tic filling material have been considered important.
The minute dimensions of narrow canals or unin-
strumented, accessory canals make the flow charac-
teristic of special interest. Additions of x-ray contrasting
compounds are necessary for the assessment of filling
quality and for prognostic evaluations.
Endodontic treatment aims at curing and/or pre-
venting apical periodontitis. The properties of en-
dodontic materials, therefore, become important also
with regard to their influence on these curative or
preventive aspects of treatment: Antibacterial prop-
erties of endodontic materials are a controversial is-
sue, whereas relative non-toxicity and/or bone-growth-
stimulating activity is considered desirable by most
clinicians and researchers.
CHEMICAL CONSTITUENTS OF SOME COMMONLY USED ENDODONTIC MATERIALS
Name Manufacturer
Gutta-percha Mynol
AH26 De Trey
Endomethasone Septodont
Kloroperka N-O Therapeutics
ProcoSol Star Dental
Ag omitted from new formula AH26.
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ENDODONTIC MATERIALS 13
Endodontic materials are intentionally applied di-
rectly on vital, soft tissues of the apical pulp or the
periodontal ligament. In a sense, this makes them
true implant materials and subject to the particularly
complex requirements, both technical and biological,
of this group of biomaterials.
RESEARCH TRENDS
Their dual requirements for biocompatibility and
sealing or obturation ability have made endodontic
materials, particularly the sealers, popular objects for
different types of research studies. The biocompati-
bility requirement was recognized very early, and
Rickert's endodontic sealer was the very first dental
material subjected to the now-traditional mucosal im-
plantation test (Rickert and Dixon, 1931). Similarly,
endodontic materials were among the first dental ma-
terials tested for biocompatibility with tissue cells cul-
tured in vitro (Keresztesi and Kellner, 1966). A long
series of biocompatibility studies has followed, in-
cluding usage studies in monkey and man (Lange-
land, 1974; Holland et al, 1977; Spangberg, 1981;
Horsted et al, 1982).
Biological Properties
Biological testing has demonstrated a large varia-
tion in the toxicological and tissue-irritating proper-
ties of the materials (Brown and Friend, 1968;
Spangberg, 1981). Cell culture experiments (Fig. 2)
have shown that the conventional, zinc oxide-eu-
genol-based sealers are toxic both in the set and par-
ticularly in the unset state (Spangberg, 1981; 0rstavik
et al, 1981). Traditionally, this effect has been related
to the content of eugenol (Cotmore et al, 1979), which
of course is available when the material is freshly
prepared, but which is also leached from the set mass
(Wilson et al., 1973). The addition of paraformalde-
hyde to some materials may increase the cytotoxicity
of this type of material (Keresztesi and Kellner, 1966;
0rstavik et al., 1981). Rosin-chloroform-type sealers
appear to be less cytotoxic, when set, than most zinc
oxide-eugenol brands (Spangberg, 1981; 0rstavik et
TABLE 2
Setting Mechanism Components
Gutta-percha; ZnO; S, Cl, Cd, Ba Ti Fe Cu
Epoxy polymer Epoxy-bis-phenol resin; Bi2O3/ TiO, Ag*;
metheneamine
Zinc oxide-eugenol ZnO, cortisone, paraformaldehyde, Pb3O4/
thymol iodide, BaSO4; eugenol
Chloroform evaporation Gutta-percha, Canada balsam, rosin, ZnO
Zinc oxide-eugenol ZnO, BaSO4, Bi-carbonate, Na-borate, rosin
14 0RSTAV1K Adv Dent Res August 1988

TABLE 3
RESULTS OF ENDODONTIC THERAPY
No. of Percent Obs. Period
Authors Year Country Operator Roots Diagnosis* success (years) Sealer Material
Guignard and Holz 1985 Switzerland Specialist 194 N 81 7 ZnO-eugenol
Swartz et al. 1983 USA Students 1770 M 90 1 ?
Morse et al. 1983 USA Specialist 458 M 95 1 Eucalyptol-
guttapercha
Barbakow et al. 1981 S. Africa GP 124 N 89 1 ZnO-eugenol
Delessert et al. 1980 Switzerland Students 250 V 96 1.5 ZnO-eugenol
Bergenholtz et al. 1979 Sweden Students 556 R 75 2 Rosin chloroform
Kerekes and 1979 Norway Students 501 M 91 4 Chloropercha
Tronstad
Jokinen et al. 1978 Finland Students 2459 M 53 2-7 Chloropercha
Adenubi and Rule 1976 England Specialists 870 M 88 ? ZnO-eugenol
Harty et ah 1970 England Specialists 1100 M 90 2 ZnO-eugenol
Grossman et al. 1964 USA Students 432 M 90 1-5 ZnO-eugenol
Strindberg 1956 Sweden Specialists 775\ M 90 Vi-10 Rosin chloroform
* N = necrotic pulps; V = vital pulps; R = revisions; M = all diagnoses.
t Originally treated roots.

al., 1981). The most commonly used synthetic resins
behave differently: Initially marked cytotoxicity (Ols-
son and Wennberg, 1985) diminishes when the ma-
terial is cured, making this type of material one of
the least cytotoxic in the set state (0rstavik et al.,
1981). The mechanisms for cytotoxicity remain ob-
scure, however.
It is fortunate for this group of materials that the
different biological tests tend to confirm each other.
Thus, the implantation tests applied on endodontic
materials (Brown and Friend, 1966; 0rstavik and Mjor,
1988) show cytotoxicity profiles similar to those of the
cell culture experiments (Spangberg, 1981; 0rstavik
et al., 1981). In short-term tests, rosin-chloroform, zinc
oxide-eugenol, chloropercha, and synthetic resin, in
that order; produce tissue reactions of increasing in-
tensity. Longer-term implantation experiments (Fig.
3) show an almost dramatic resolution of the tissue
response to cured synthetic resins, whereas the
chemically less stable zinc oxide-eugenol and chlo-
ropercha are accompanied by persisting, though di-
minishing, inflammation (0rstavik and Mjor, 1988).
It would be reasonable to compare the results from
cell culture or implantation experiments with so-called
usage studies of endodontic materials, i.e., histologic
assessment of tissue reactions to root fillings in man
or experimental animals. A number of studies have
been carried out with endodontic treatment of mon-
keys, dogs, cats, and rats, some of which also include
comparisons of different endodontic materials. One
major difficulty with the usage test is the frequently
uncontrolled influence of other (technical and biolog-
ical) factors on the outcome of treatment. For in-
stance, control of infection may be difficult, and the
filling material is often separated from the vital, re-
acting tissue by a mass of dentin fillings. In general,
there seems to be a tendency for endodontic materials
to act less tissue-irritating in usage tests than might
be expected from the cell culture or implantation ex-
periments.
Physical Properties
On the technological side, interest has focused on
the sealing properties of the root canal filling. Several
studies, mostly performed in vitro, have investigated
the leakage of dyes (Antoniazzi et al., 1968; Beyer-
Olsen et ah, 1983), radioisotopes (Higginbotham, 1967),
bacteria (Kos et al., 1982), or electrolytes (Mattison
and von Fraunhofer, 1983) at the dentin/endodontic
filling interface. Other parameters — e.g., solubility,
flow, working and setting time, radiopacity, and ad-
hesive properties —have also been assessed (Mc-
Comb and Smith, 1976; 0rstavik, 1983 a, b; Beyer-
Olsen and 0rstavik, 1981; 0rstavik et al, 1983a).
Although the results from different researchers are
somewhat variable, a pattern of the different material
types with respect to sealing properties is emerging.
Zinc oxide-eugenol preparations afford good seals
against leakage in most tests; resin-based sealers are
intermediate in sealing ability; chloropercha formu-
lations show the most leakage (Table 4). On the other
hand, adhesion of the materials to dentin is achieved
only with synthetic resin (McComb and Smith, 1976;
0rstavik et al., 1983a), and the solubility in water is
definitely lower for this type of material than for other
endodontic materials (0rstavik, 1983b).
Whereas the flow properties and film thickness are
important characteristics for the distribution and spread
of the sealer inside the root canal and its ramifica-

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Vol. 2 No. 1
75 -
ENDOMETHASONE
50 - \
V*•—AH 26 ]l
11
25 - \ 'fORFENAN |
r LU
J<LOROPERKA NO
HYDRON
75 -
FRESH 7 DAYS
1 DAY
Fig. 2 —Cytotoxicity of endodontic materials as measured by the
51
chromium-relea?e method. Values for positive ( + ) and negative
( - ) controls are indicated by the horizontal lines. From 0rstavik
etal, 1981.
tions, relatively little attention seems to have been
paid to these properties in the development of the
materials. A minimum of flow is necessary for the
sealer to adapt to the irregularities of the canal; how-
ever, materials that are too free-flowing may easily
be displaced periapically. Used in conjunction with
the standardized method of root canal filling, sealers
with large grains —i.e., high film thickness — may in-
terfere with proper seating of the master point (0r-
stavik, 1982). There is great variation among commonly
used materials with regard to both film thickness and
flow (Figs. 4,5).
Clinical Tests of Endodontic Materials
In striking contrast to the numerous technological
and biological studies is a virtually complete lack of
comparative, clinical-radiographic studies on endo-
dontic materials. This is remarkable, particularly in
view of the many clinical-radiographic follow-up
studies that have been published (Strindberg, 1956;
Grossman et al., 1964; Harty et al, 1970; Adenubi and
Rule, 1976; Jokinen et al., 1978; Kerekes and Tronstad,
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ENDODONTIC MATERIALS 15
0
i
CO
CO
O
Q.
CO
LU
cc
o
w
CO
CO
CO
o
IMPLANTATION PERIOD, days
Fig. 3 —Tissue responses to endodontic sealers implanted subcu-
taneously in rats. AH: AH 26. EM: Endomethasone. KP: Kloro-
perka N-0. PS: ProcoSol. Tissue responses to materials contained
in polyethylene tubes were assessed histologically on a no/slight-
to-severe scale. Each point represents a numerically weighted av-
erage response based on from four to seven specimens. From 0r-
stavik et al., 1981; 0rstavik and Mjor, 1988.
1979; Bergenholtz et al, 1979; Delessert et al, 1980;
Barbakow et al, 1980 a, b; Morse et al, 1983; Swartz
et al, 1983; Guignard and Holz, 1985). This lack of
clinical correlates to laboratory assessments of en-
dodontic materials is probably the major impediment
to a scientific development of new and improved ma-
terials.
In consequence, most changes in the selection and
application of endodontic materials over the past dec-
ades have been fads based on ingenuity in advertis-
ing rather than progress based on scientifically founded
developments. Thus, no new material can present
documented improved biocompatibility, improved
healing properties, improved sealing properties, or
improved clinical performance. Technological im-
provements in devices for application of gutta-per-
cha—e.g., the various compactors (Kerekes and Rowe,
1982) and guns for mould injection (Marlin et al,
1981) —may offer advantages in the form of time-sav-
ing and ease of manipulation. However, there are no
data to indicate that the use of these devices improves
16 0RSTAVIK Adv Dent Res August 1988

TABLE 4
RESULTS OF LEAKAGE TESTS
Author Year Technique Material Leakage*
Higginbotham 1967 Radioisotope Kloroperka + ++
Diaket +
Procosol +
Antoniazzi et al. 1968 Dye Kloroperka + + 4-
Kerr (Rickert) + +
AH26 + +
Mattison and von 1983 Electrochemical Diaket +++
Fraunhofer Procosol +
Beyer-Olsen et al. 1983 Dye Kloroperka ++++
AH26 +++
Endomethasone ++
Procosol +/ —
* Due to great variations among authors in experimental design and units of measurement, the results have been arbitrarily
assigned values for leakage increasing with increasing number of + .

50- 50
EstSsone
Endomethasone
Eucaryl Poudre
Traitement SPAD
Forfenan

Eucaryl Pate Fl 40- 40

Tubli-Seal
Cresopate
Diaket
Diaket A

Hydron
Kloroperkka 30- 30
Pulpdent
Hermetic
AH 26
PROCOSOL
Kerr PCS AH 26 ^•ENDOMETHASONE
Kloroperka N-0
Merpasone 20- 20
Kri 1 Paste
Propylor

N2 Universal
Roth 811
N2 Normal
Form.G. Ivanoff PULPDENT RCS -10
ESiocalex 6-9

20 40 60 160

FILM THICKNESS, pm
Fig. 4 —Film thickness of endodontic sealers. See also 0rstavik,
1982. 2:1 4:1 8:1 8:1 KM
POWOER-TO-UQUO RATIO, g/mi
Fig. 5 —Flow of endodontic sealers as a function of powder-to-
liquid ratio. From 0rstavik, 1983a.
the success rate or increases the number of teeth that
may be conserved by endodontic treatment. More-
over, the current, ardent marketing of sealers con-
taining calcium hydroxide appears to have very few, with some of the currently recognized laboratory re-
if any, comparative studies to back up the claims of quirements, but which rely on unsubstantiated claims
biocompatibility and healing properties. of superior clinical performance as a competing edge
It would seem evident from the above that research in comparison with traditional products.
and development of endodontic materials are hin- The lack of clinical correlates also reflects on the
dered by the lack of acceptable procedures for the "accepted" properties tested in the laboratory: Re-
testing of their clinical performance. Therefore, new quirements for sealing properties, physical stability
materials are marketed which mayfromoradr.sagepub.com
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comply and usebiocompatibility,
on July 22, 2011 For personal only. No other uses without permission.for example, may be well-
Vol. 2 No. 1
founded on thorough considerations of what are de-
sirable properties. However, it should be kept in mind
that they are based on just that: considerations, and
not on clinically proven relevance. Therefore, with
the coming of clinical testing of endodontic materials,
the so-called "ideal" physical and biological proper-
ties of these materials may have to be revised. More-
over, with an increased knowledge of clinical
performance, new in vitro designs may be applied
which more accurately assess particular clinical com-
plications. Thus, the guinea pig maximization test has
been applied and the test results related to the clinical
occurrence of an allergic reaction to endodontic ma-
terials (Hensten-Pettersen et aL, 1985), and a neuro-
toxicity model has been adapted for the testing of
endodontic sealers (Brodin et aL, 1982; Brodin and
0rstavik, 1982) implicated in paresthetic reactions of
the inferior alveolar nerve to endodontic treatment
(0rstavik et aL, 1983 b; Rowe, 1983).
Finally, the clinical assessment of the materials must
take into account the level, i.e., the frequency and
severity, of the problems. Fig. 6 is an illustration of
some examples of clinical complications with endo-
dontic materials occurring at various levels. It should
be remembered that the more severe complications
may occur with extremely low frequency. Therefore,
in a clinical trial the number of subjects required for
the assessment of these complications may be pro-
hibitively large, and we may also have to rely on
enlightened inferences in the future.
Another factor which may have influenced the de-
velopment of endodontic materials is the compara-
tively small market from the point of view of
manufacturers. Endodontic materials are a low-cost
area with little chance of research and development
revenue in the form of high-priced new products,
and new endodontic materials have usually been spin-
offs from other areas of research. Moreover, the en-
dodontic establishment may have been overzealous
in its skepticism of new products. This traditionalism
also tends to become cemented by the divergent tech-
niques and materials taught in different dental schools
and in the post-graduate programs.
SEVERITY
Treatment Local com- Systemic
failure plications effects
FREQUENCY
Fig. 6 —Failures and complications after use of endodontic mate-
rials: Incidence versus severity.
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ENDODONTIC MATERIALS 17
CURRENT DEVELOPMENTS
General
Pulp biology and endodontics as areas of scientific
research have prospered in recent years. Pulpal and
periodontal reactions to trauma (Hammarstrom et aL,
1986) and to infections (Fabricius et aL, 1982a) are
under study, with application of clinical research
strategies as well as the tools of the basic sciences:
pulpal physiology and the immunology and bacteri-
ology of infections of the pulp and periapex.
In endodontic practice, the improvements in the
standardized technique have been disseminated to
many practicing dentists and specialists, who feel that
their performance has thereby improved. Reciproca-
ting angle pieces and, more recently, the introduction
of sonic and ultrasonic devices for instrumentation
may ease and improve canal preparation (Klayman
and Brilliant, 1975; Stamos et aL, 1985).
Bacterial Studies
The current activity in endodontic microbiology may
be of greater significance for endodontic materials.
Improved methods of bacteriologic sampling from root
canals and periapical tissues (Tronstad et aL, 1987)
have led to better characterization of the infecting
bacteria, which turn out to be a lower number of
genera than previously believed (Table 5). A strategy
of selective antibacterial treatment may therefore be
envisaged, and controlled-release delivery systems for
antibiotics or other antibacterial components, also in-
volving filling materials, are conceivable. Moreover,
with improved possibilities for bacteriological diag-
nosis, selection among materials with different activ-
TABLE 5
MICRO-ORGANISMS MOST COMMONLY
ASSOCIATED WITH PULPOPERIAPICAL INFECTIONS
Genus Characterization
Bacteroides G - , anaerobic, pleomorphic rods
Eubacterium
Bifidobacterium G +, anaerobic rods
Fusobacterium G —, anaerobic rods
Peptostreptococci
Peptococci G + , anaerobic cocci
Wolinella
Risk of G —, anaerobic, mobile rods
Selenomonas
fatality
Streptococci
Enterococci G -f, facultative cocci
Lactobacillus G + , facultative rods
Based on Sundquist, 1976; Moller et aL, 1981; Fabricius
et aL, 1982b; Bystrom et aL, 1985; Haapasalo et aL, 1985;
Haapasaioef a/., 1986.
18 0RSTAV1K
ity toward different bacterial species (Cox et al., 1978;
0rstavik, 1981) becomes feasible. Work is in progress
on the controlled delivery of drugs into root canals;
however, at this point in time, activity is mainly fo-
cused on temporary dressing medicaments (Barnett
et al, 1986).
Tissue Reactions to Endodontic Materials
In contrast, the philosophy on endodontic filling
materials has considered release of material compo-
nents to be undesirable, indeed associated with in-
flammatory reactions to the materials. Whereas this
concept could change if bacteriostatic or bactericidal
agents with no or few tissue-irritating properties could
be controllably and selectively leached from the ma-
terial, current research is concerned with the identi-
fication and localization of material components in
the tissues. Moreover, the analysis of vascular and
cellular reactions to the endodontic material is still of
primary interest in endodontic research.
This interest is based on the supposition that toxic
components of the material may initiate or perpetuate
periapical inflammation (Fig. 7), which in turn may
necessitate the removal of the tooth. While it has long
been recognized that unset endodontic sealers are ir-
ritating to tissue (Keresztesi and Kellner, 1966;
Langeland, 1974), only recently have the mechanisms
for this irritation been subjected to a more detailed
study.
One of the advances in microscopic diagnosis is the
application of element analysis to tissue sections and
cell culture preparations. At our laboratory, we have
applied this technique to implantation studies with
endodontic sealers and to clinical biopsies from cases
of endodontic failures with the material as suggested
Fig. 7 —Adverse tissue reactions to en-
dodontic filling material displaced peri-
apically. M: Material particles. I:
Inflammatory reaction. Zinc oxide-eu-
genol cement with paraformaldehyde
addition (N2). Original magnification
40 x.
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Adv Dent Res August 1988
etiology. Fig. 8 is a brief outline of the methodology,
and shows the use of the scanning electron micro-
scope on paraffin-embedded tissue sections. Fig. 9
illustrates the results obtained for a clinical specimen
analyzed microscopically, by back-scattered scanning
electron microscopy (BSEI) and by energy-dispersive
micro-analysis of particles identified by BSEI. While
the analysis is less efficient for elements of atomic
weights below 20, precise, qualitative or semi-quan-
titative, measurements may be made of microscopic
and submicroscopic (<1 jxm) particles released from
the endodontic materials. The information obtained
is easily related to inflammatory reactions observed
in neighboring sections by light microscopy (0rstavik
and Mjor, 1988). Moreover, insight into the mecha-
nism of tissue damage may be obtained through cor-
relation with more basic studies on cytotoxicity of
endodontic material components. Thus, the recent
documentation of the toxic properties of zinc (Helge-
land, 1977; Meryon and Jakeman, 1985), combined
with the demonstration of zinc in particles associated
with inflammatory reactions to endodontic sealers
(Table 6), may indicate that the zinc oxide so com-
monly used in endodontic materials may exert a neg-
ative influence on the tissues.
Recent research into the cell and tissue reactions to
endodontic materials and their components also sheds
new light on the influence of these materials on cel-
lular functions. Particularly, studies on macrophage
function (Biggs et al., 1985; Syrjanen et al., 1985) in
the presence of material components may indicate
that inflammatory cells attack and dispose of different
endodontic materials with different mechanisms and
efficacy. Improved knowledge of the host's ability to
deal with elements and particulate matter from en-
Vol. 2 No. 1 ENDODONTIC
EDXA
ELECTRON
BEAM OF SEM
BSEI
SEI
SPECIMEN
Fig. 8 —Element analysis of tissue sections in the scanning electron
microscope (SEM). SEI: Secondary electron image (regular SEM).
BSEI: Back-scattered electron image displaying components with
elements of high atomic weights. EDXA: Energy-dispersive spec-
trum of elements detected.
dodontic materials may aid in the selection among
existing products and in the manufacture of new
products.
Case Reports of Adverse Reactions
to Endodontic Materials
The literature is replete with case reports of atypical
reactions to and mishaps during endodontic treat-
ment. As a whole, endodontic materials are fortu-
nately relatively innocuous, and adverse reactions are
few and therefore not easily compiled and analyzed
with respect to incidence and severity. Case reports
therefore remain an important source of information
Fig. 9 —Tissue reaction to subcutaneous implant of AH 26. A: Section stained with hematoxylin and eosin displays intense inflammation.
B: BSEI image for orientation in the scanning electron microscope showing tissue-associated bright patticles of high atomic weights (arrows).
C: Identification of bismuth in EDXA spectrum from area encircled in B. Original magnification of micrographs 40 x .
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MATERIALS 19
on the clinical qualities of endodontic materials. Re-
cently, damage to the inferior alveolar nerve subse-
quent to endodontic treatment of posterior teeth of
the lower jaw has been the subject of several reports
and literature surveys (0rstavik et al., 1983b; Rowe,
1983). In laboratory testing, a modified neurotoxicity
assay to endodontic filling materials has demon-
strated that the part played by the material may be
important in this clinical state. The pattern of neu-
rotoxicity in vitro correlates well with the association
of the material with clinical paresthesia (Fig. 10), and
this model may be advantageous in the testing of
newly-developed products (Brodin et al., 1982; Brodin
and 0rstavik, 1982; Schippers et al, 1986).
Allergic reactions to endodontic materials may oc-
cur, and reports of clinical cases have surfaced in the
literature (Horsted and S0holm, 1976; Barkin et al.,
1984). Also for this clinical condition there are ac-
cepted laboratory methodologies which may be used
to screen materials for allergenic properties (Hensten-
Pettersen et al., 1985). Particularly with regard to the
sensitizing properties of many synthetic polymer sys-
tems and antibacterial agents, it would seem proper
to suggest that new materials should be subjected to
a sensitization test. The fairly high sensitizing poten-
tial of commonly used sealers (Table 7) may actually
point to the desirability of improving some of the
most commonly used materials in just this respect.
Clinical Studies
Being engaged in standardization work on both
technological and biological aspects of endodontic
materials, NIOM launched a research program with
these materials which also included a clinical study.
As indicated previously, few if any comparative clin-
— Bi
4 8 12
X-RAY ENERGY, KeV
w .*.
20 0RSTAVIK Adv Dent Res August 1988

TABLE 6 denounce x-ray analyses of root-filled teeth as an ad-

ELEMENTS IDENTIFIED IN TISSUE SECTIONS FROM equate basis for scientific research. To overcome this
IMPLANTS WITH ENDODONTIC SEALERS IN THE difficulty, we investigated the possibility of making
RAT the radiographic diagnosis more objective and repro-
ducible by applying a scoring system. As a basis for
Particle the clinical studies on endodontic materials, there-
Sealer Size Elements fore, a periapical index termed the PAI was devel-
AH26 25 fim Ti, S, Ag oped (Fig. 11) (0rstavik et al, 1986). Similar in concept
Endomethasone 25 \xm Zn, Ba, S, Pb to the successful indices now so familiar in periodon-
ProcoSol 25 |xm Zn, Bi, P tal, caries, and plaque research, this index is based
Kloroperka N 0 50p,m Zn, Ca, P on a delineation of steps on a progressive disease
scale. The steps on PAI are represented by reference
Data from 0rstavik and Mjor, 1988. radiographs of teeth with various degrees of apical
periodontitis verified histologically in a necropsy study
of 299 root-filled teeth, including successes as well as
100-- • AO
failures by conventional criteria (Brynolf, 1967). This
UJ PROCOSOL index allows for a possible blind score of experimen-
h 80-
/ AH26 ^
tal teeth in coded radiographs and permits unbiased
assessment of the radiographic appearance. Exten-
§1 60-
| fc DIAKET
sive analyses of parameters for reproducibility and
accuracy indicate that the PAI may be used with clin-
-I ical and statistical confidence in clinical experiments,
H 40-
i I ys^KLOROPERKA N-0 allowing for comparisons between subgroups of teeth

V
UJ i.
Q ©
20-
with systematic or randomized differences (0rstavik
IJ
et al, 1986; 0rstavik, 1988).
rX-\ ENDOMETHASONE, N2
Q. The PAI scoring system has been applied in a con-
< -30 -20 -10 10 20 30 trolled study on the clinical performance of three en-
TIME, minutes dodontic sealers used in combination with a
Fig. 10-Neurotoxicity of endodontic sealers. The conductivity of standardized gutta-percha/sealer technique (Orstavik
rat phrenic nerve was followed during (negative time scale) and et al, 1987). The choice of sealer was randomized by
after (positive time scale) exposure of the nerve to the sealers. the throwing of a die when the tooth was ready for
ProcoSol, Kloroperka, Endomethasone, and N2 caused an imme- filling. A total of 810 roots were filled with either AH
diate stop in nerve action potential, whereas AH 26 and Diaket 26, a synthetic polymer, ProcoSol, a zinc oxide-eu-
only slowly reduced the amplitude of the action potential. When genol cement, or Kloroperka N 0 , a rosin-guttaper-
the root filling material was removed and the nerve was washed cha-zinc oxide-balsam-chloroform mixture, in
in the buffer solution, ProcoSol-exposed nerves regained most of
conjunction with a master cone of gutta-percha. At
their action potential amplitude, whereas nerves treated with En-
domethasone or N2 showed permanent blockage of nerve con-
the three- and four-year follow-up, 451 and 289 roots,
ductance. The Kloroperka, Diaket, or AH 26-treated nerves regained respectively, were available for clinical and radio-
some conductance. Based on data from Brodin et al., 1982. graphic re-examination. Computer analysis permit-
ted stratification of the material to correct for the
TABLE 7 influence of clinical and radiographic characteristics
INCIDENCE OF SENSITIZATION BY AND SEVERITY
of known influence on the prognosis, other than the
OF RESPONSE TO ENDODONTIC SEALERS
sealers used.
Tables 8 and 9 and Fig. 12 show some salient re-
Sealer Incidence Severity sults from this study. The results document that the
AH26 12/18 PAI scoring system is suitable for follow-up exami-
Endomethasone 9/20 nations and for experimental, prospective clinical
Kloroperka 10/20 studies in endodontics. Apparently, the PAI scores
ProcoSol 6/20 are highly discriminatory and may be subjected to
powerful statistical tests; the possibility for unbiased
Data from Hensten-Pettersen et al, 1985. recording of the periapical situation makes the results
"true" in a numerical or statistical sense; and the his-
ical studies on endodontic materials had been per- tological verification (Brynolf, 1967) of the reference
formed. Probably the main obstacle to this type of radiographs lends credence to the supposition that
research has been the lack of accepted and sensitive the results are also "true" in a biological sense.
clinical criteria for the results of treatment. The sub- The use of the PAI made possible a discrimination
jectivity and non-reproducibility of radiographic as- of the results obtained with different sealers. Al-
sessment of endodontic failure or success have been though the conventional failure rate was low and did
demonstrated repeatedly (Goldman et al, 1972; Reit nol permit discrimination between the sealers, the
and Hollender, 1983), and the tendency has been to distribution of scores in the "doubtful" categories 2

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Vol. 2 No. 1 ENDODONTIC MATERIALS 21

Fig. 11—The periapical index. The radiograph of a given root apex area is compared with the radiographs of the scale, and the root is
assigned a PAI score corresponding to the PAI score of the reference radiograph which it resembles the most. See also 0rstavik et al.,
1986.

TABLE 8 total material, which resulted in a sufficient number

IMPROVEMENT IN PERIAPICAL STATUS of teeth in each subgroup for adequate statistical (RI-
SUBSEQUENT TO ENDODONTIC TREATMENT DIT) analysis.
The PAI scoring system, with its possibilities for
PAI Significant unbiased scoring and intra- and interobserver har-
Time N Score — Ridit Change monization, applied in clinical studies where the en-
Pre-operative 810 0.31 t dodontic material is the only randomized variable,
1 year 546 0.23 t forms a sound basis for clinical testing and compar-
2 years 493 0.16 isons of endodontic materials. Combined with a ju-
3 years 451 0.14 dicious selection of physical and biological tests, such
4 years 289 0.12 clinical testing may ultimately determine the suita-
bility or advantages claimed for new products.
* PAI score ridit values connected with vertical lines are
not significantly different (p > 0.05).
NEW MATERIALS
t Denotes that the corresponding PAI score ridit values
are significantly different from all other ridits. Regulatory Action
Data from 0rstavik et al., 1987. There is a framework, however frail, which should
be reinforced for the development and approval of
and 3 of the PAI clearly documented that Kloroperka new materials. Within the US, ADA Specifications
N0 performed less well than did AH 26 and ProcoSol. No. 56, Endodontic Filling Materials, and No. 41,
This rating persisted through all stratifications of the Recommended Standard Practices for Biological Eval-

TABLE 9
PAI SCORE ANALYSIS OF PERIAPICAL STATUS FOR ROOTS FILLED WITH 3 DIFFERENT SEALERS
Time AH26 Kloroperka ProcoSol Statistical Significance
Pre-operative 0.29 0.33 0.31 N.S.
1 year 0.20 0.25 0.22 KP > AH, PS(p < 0.05)
2 years 0.15 0.19 0.16 KP > AH, PS(p < 0.05)
3 years 0.12 0.19 0.12 KP > AH, PS(p < 0.01)
4 years 0.10 0.16 0.10 KP > AH, PS(p < 0.05)
Data from 0rstavik et al., 1987.
The figures in the Table are mean ridit values of the PAI score data. The lower the mean ridit, the better the periapical
radiographic status of that group.
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22 0RSTAV1K Adv Dent Res August 1988

PREOPERATIVE STATUS not documented compliance with any of the existing

PAI score 1 standards or specifications. Indeed, for some of them
.100 T it is apparent that they do not comply with important
Vital pulp
parts of some specifications. This must be considered
Supported function a most unfortunate situation: The painstaking work
> 1/2 marg. bone of the endodontists/material scientists leading up to
complete specifications and standards is put aside,
and new materials are marketed with claims of, but
without documentation of, superior new qualities but
which are not even tested for mandatory, minimum
properties.
o Acceptance of and adherence to the already exist-
E ing requirements spelled out in specifications and
w standards are therefore the first steps in an improved
o .050 -
DC
documentation of new endodontic materials.
UJ
< Research Avenues
Regulations based on today's or yesterday's knowl-
• AH26 edge must not act as obstacles to research and de-
O KLOROPERKA velopment of new types of products. New ways to
D PROCO-SOL solve the obturation/biocompatibility/healing prob-
lems associated with endodontic materials should
constantly be sought. There is currently some re-
search activity which may turn up new concepts, if
not principles, for root canal filling.
(1) Physical separation of the biocompatibility function
0 1 2 3 4 and the obturating function (Fig. 13).— The beneficial
TIME, years
clinical effects of temporary dressings with calcium
hydroxide have prompted attempts to preserve these
Fig. 12 —Periapical radiographic status of roots filled with AH 26, effects in the permanent root fillings. Clinicians are
Kloroperka N-0, or ProcoSol. Higher ridit values indicate more
signs of apical periodontitis in the corresponding radiographs. The
known intentionally to leave the most apical part of
teeth included were selected on the basis of optimum pre-operative the c mal filled with Ca(OH)2 when placing the per-
status. See also 0rstavik et al, 1987. manent filling. The sealers containing Ca(OH)2 have
been marketed with the same philosophy. Packing of
the apical part with "biocompatible" powders of den-
tin chips (Petersson et al, 1982), hydroxyapatite (Cal-
uation of Dental Materials, contain a selection of tests lis and Santini, 1985), or collagen-calcium phosphate
easily performed and controlled for evaluation of new (Nevins et al., 1980) has also been attempted. Theo-
endodontic materials. The International Organization retically, this approach is an interesting one, in that
for Standardization has published, or is in the process the traditional biological/technical compromise may
of publishing, similar test methods for these materials be discarded, and the optimum requirements for both
(Table 10). biocompatibility and obturating function may be
In this context, it is interesting to note that the most sought and satisfied.
recent entries on the endodontic materials market have (2) Mechanical "plugging" of dentin canal walls. —Laser

TABLE 10
REGULATORY DOCUMENTS PERTAINING TO THE TESTING OF ENDODONTIC MATERIALS
Agency Document
ISO — International Organization for Standardization ISO/TR 7405 —Biological evaluation of dental materials
ISO/DIS 6876 —Dental root canal sealing materials
ISO/DIS 6877-Dental root canal obturating points
ANSI/ADA—American Dental Association ANSI/ADA Specification No. 41. Recommended Standard Practices
for Biological Evaluations of Dental Materials
ANSI/ADA Specification No. 56. Endodontic Filling Materials
BSI- British Standards Institution BS 5828:1980 Methods of Biological Assessment of Dental Materials

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Vol. 1 No. 1
Fig. 13 —Separation of biocompatibility and sealing functions in
endodontic materials. A: "Biological" plug, e.g., dentin chips or
calcium hydroxide. B: "Mechanical" plug, e.g., conventional or
improved sealing materials.
technology seeks new applications, one of which is
the surface glazing of root canal walls. The concept
would be to seal off the dentinal tubules, apical fo-
ramen, and accessory canal openings with sintered
masses of dentin or enamel powder (Zakariasen et
al., 1986). Another approach to the problem of dentin
tubule plugging is impregnation of tubules with syn-
thetic resin. Research activity in this area may be tem-
pered by the lessons of history: Riebler's paste and
more recently Traitement SPAD were developed on
this principle with a water-compatible bakelite-type
resin. The many adverse tissue reactions to these ma-
terials call for caution when attempts are made to
adapt this principle once more to endodontic treat-
ment. Finally, the development of dentin bonding
agents may improve adaptation of the material to the
root canal walls (Zidan and ElDeeb, 1985).
CONCLUSIONS
Endodontic treatment is reported to succeed in from
80 to 95% of the cases treated. Failures are mostly
associated with the occurrence or persistence of in-
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ENDODONT1C MATERIALS 23
fection, to a lesser extent with adverse tissue reac-
tions to the root-filling materials. Whereas root-filling
materials and techniques display widely different
sealing qualities, their clinical performance is not sim-
ilarly divergent. Although improved sealing proper-
ties may be desirable, great improvements in success
rates are unlikely. Moreover, although the materials
vary greatly in biocompatibility, there are few data to
indicate that superior biocompatibility is essential for
endodontic treatment success. Endodontic problem
cases are usually successfully treated when the anti-
infective measures have been effective. Significant
improvement in endodontic therapy may be expected
when control of infection can be achieved regularly
and predictably. To the extent that new materials,
material combinations, or techniques can contribute
to this end, real improvements in endodontic mate-
rials may be feasible.
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