R

Success of an
alternative for
interim management
of irreversible pulpitis
ROGER A. McDOUGAL, D.D.S., M.S.; E. OLUTAYO
DELANO, D.D.S., M.S., Dip. A.B.O.M.R.; DAN
CAPLAN, D.D.S., Ph.D.; ASGEIR SIGURDSSON,
D.D.S., M.S.; MARTIN TROPE, D.M.D.

ulpectomy and endodontic therapy represents

the appropriate treatment of frank carious
exposures of the pulp in mature permanent
teeth among other indications. In most cases,
when a patient seeks treatment for a carious
exposure and associated pain, the immediate option is
one of two extreme treatment procedures. The first
option is initiation of endodontic therapy, in which completion of treatment is recommended
The interim immediately or at least within a few
weeks or months. After completion of
treatment of
this treatment, it is suggested that most
eugenol teeth be restored with an extensive
pulpotomy coronal restoration.
The second option is extraction of the
using either
of two offending tooth. Afterward, the patient
intermediate must deal with the morbidity of the loss
of a potentially restorable permanent
restorative
tooth. In addition to coping with the loss
materials of a natural tooth, the patient generally
reliably is encouraged to replace the extracted
prevented pain tooth prosthetically to maintain the
for six months. integrity of the dental arches. Although
in most cases there are prosthetic
options available to the patient, many of
them are more expensive than maintaining the tooth
and having it restored after endodontic therapy. Unfortunately, the patient often will focus on the high initial
cost of endodontic therapy relative to extraction and
elect for the latter purely for financial reasons. In many

ABSTRACT
Background. Extraction and endodontic
therapy are treatment options for irreversible pulpitis. Extraction often is chosen
for financial reasons. The authors conducted a study to investigate an alternative
interim therapy.
Methods. The authors recruited patients
(N = 73) with irreversible pulpitis and
whose teeth were restorable but who opted
for extraction owing to financial reasons.
After undergoing pulpotomy, the teeth were
restored by random assignment with one of
two intermediate restorative materials:
Caulk IRM (Dentsply Caulk, Milford, Del.)
(Group I, n = 38) or an IRM base with glass
ionomer core (Fuji IX GP, GC America,
Alsip, Ill.) (Group II, n = 35). The authors
monitored the teeth over six and 12 months
for pain, integrity of restoration and
radiographic periapical status by
densitometric analysis.
Results. By six months, 10 percent of
subjects remaining in the study (Group I,
n = 27; Group II, n = 25) reported pain; by
12 months, 22 percent (Group I, n = 22;
Group II, n = 18) reported pain. A
twotailed Fisher exact test showed no significant difference (P .05) between groups
at either time interval. No apical radiographic change was noted in 49 percent of
teeth at six months (Group I, n = 18; Group
II, n = 19) and 42 percent at 12 months
(Group I, n = 16; Group II, n = 15). 2 analysis demonstrated no significant differences
(P .05) between groups. Seven of 22 restorations in Group I and four of 18 in Group
II required repair at 12 months with no statistical difference (2 analysis, P .05).
Conclusions. The interim treatment of
eugenol pulpotomy using either restorative
material reliably prevented pain for six
months. For longer periods, both restorations may require repair.
Clinical Implications. This option
should preserve the integrity of the arch
and extend the use of the tooth while the
patient finds the means to finance complete
endodontic treatment.

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R E S E A R C H

of these cases, the extracted tooth never is subsequently replaced, resulting in compromise of
intra-arch and interarch integrity.
Because the vast majority of dental emergencies are unscheduled, the practitioners goal is to
provide predictable, effective treatment for them
in a minimal amount of time. In cases in which
endodontic therapy is the treatment of choice and
the symptomatic tooth has a vital pulp, a full
pulpotomy has been proven to be effective in
relieving pain 96 percent of the time.1 The term
pulpotomy denotes the removal of the portion of
the pulp tissue that has undergone degenerative
changes, leaving behind healthy and vital tissue.
The rationale behind the removal of this inflamed
tissue is that some sort of dressing can be placed
on the remaining healthy and uninflamed pulp.
Since it is difficult to determine accurately the
depth to which to remove the inflamed tissue, by
convention, in a full pulpotomy procedure, pulp is
removed to the level of the cervical line or to the
level of the root canal orifices.
After pulpotomy, the access preparation is
filled with some type of restorative material in an
attempt to prevent bacterial infection of the
remaining root canal space. Kakehashi and colleagues2 were the first to demonstrate that bacteria were the primary etiologic factor causing
pathosis. Since then, several investigations have
supported this finding.3-5 It also has been shown
in several studies that the success rate of
endodontic therapy is considerably higher in
teeth without periapical lesions than in those
with lesions.6-8 Considering the objectives of preventing apical periodontitis, or AP, while at the
same time providing treatment in a timely
fashion, it is desirable that the material provide
an adequate bacterial seal and be relatively easy
to place.
Intermediate restorative material (Caulk IRM,
Dentsply Caulk, Milford, Del.) is a polymerreinforced zinc oxideeugenol, or ZOE, preparation that has been tested extensively and often is
used as a provisional restorative material after
pulp therapy. As a provisional restorative
material, it has the advantages of being relatively
inexpensive and easy to handle, while still providing adequate seal of the root canal space. The
tight seal provided by IRM is well-documented in
the literature,9,10 but little is known about how
long this material can remain intact intraorally.
One study indicated that the seal provided by
IRM begins to leak approximately three weeks
1708

after placement,11 while the manufacturer recommends use for up to one year.
Conventional glass ionomer shows some
promise as an alternative to ZOE-based restorative materials. Compared with ZOE, most glass
ionomers also are relatively easy to place, and
these products can have superior wear characteristics. Studies also have shown that glass
ionomers perform well in preventing leakage.12,13
Considering these characteristics, glass ionomer
may serve as a better long-term interim restoration than IRM.
If natural teeth are maintained asymptomatically and without formation of AP for at least one
year with either of these restorative methods, this
type of therapy may serve as a viable option to
patients who wish to save their teeth but cannot
afford to do so.
We conducted a study to determine whether
dpulpotomy of a vital pulp would result in
interim relief of pain;
dthere was a difference between the incidence of
AP when the tooth was restored with either ZOE
alone or ZOE with a glass ionomer surface seal;
dthere was a difference in the durability of restorations of ZOE alone and ZOE with a glass
ionomer surface seal over six and 12 months.
SUBJECTS, MATERIALS AND METHODS

We obtained approval for this project from the

University of North Carolina at Chapel Hill
School of Dentistrys Committee on Investigations
Involving Human Subjects. Patients who visited
the University of North Carolina School of Dentistrys Urgent Care Clinic for treatment were
considered for this study. We accepted subjects
for this study if they met the following criteria:
dthey were between 18 and 65 years of age;
dthe symptomatic tooth was diagnosed with
irreversible pulpitis;
dthe tooth was able to retain a direct intracoronal restoration;
dtreatment had not commenced on the tooth as
a result of the presenting symptoms;
dno radiographic AP or severe marginal periodontitis was associated with the symptomatic
tooth;
dthe patient chose to have extraction exclusively
for financial reasons.
We excluded subjects teeth from the study if
dthe subject had a history of diabetes or any
other condition that might compromise the pulps
immune response;

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R E S E A R C H

dthe subject had a medical condition that

required long-term antibiotic therapy or antibiotic
prophylaxis before treatment.
We recruited subjects over an 18-month period.
After the preliminary evaluation and diagnosis
in the urgent care clinic, we gave prospective subjects the option of participation in this study if
they expressed a desire to retain the problematic
tooth but were unable to afford complete
endodontic therapy. They had to pay for the emergency treatment and would get a refund at the
end of the study period. After receiving a verbal
explanation of the study design and objectives,
patient/provider obligations and the potential
risks involved, the patients reviewed and signed
consent forms to indicate their agreement to participate in the study. Two clinicians (R.A.M. and
E.O.D.) then performed a comprehensive clinical
evaluation in an effort to identify the symptomatic tooth and develop a preoperative pulpal
and periapical diagnosis. These clinicians performed the diagnostic examinations and provided
all treatment.
The clinicians obtained preoperative periapical
radiographs using standardized radiographic
technique and individual bite-blocks attached to
the beam-guiding device (XCP Bite-Blocks,
Dentsply Rinn, Elgin, Ill.).
The clinicians performed a full pulpotomy at
least to the level of the root canal orifice, but not
exceeding three millimeters apical to the orifice,
after caries excavation under rubber dam isolation. After pulpotomy, the clinicians restored each
tooth with either IRM (Group I) or IRM base with
conventional glass ionomer core (Fuji IX GP, GC
America, Alsip, Ill.) (Group II) by random assignment with a coin toss.
After treatment, the clinicians obtained a standardized periapical radiograph with a custom bite
block using vinyl polysiloxane bite registration
material applied to a periapical radiograph holder
bite block (XCP Bite-Blocks, Dentsply Rinn). The
radiographs were taken with double-pack no. 2
Ultra-speed intraoral dental film (Eastman
Kodak, Rochester, N.Y.) using an intraoral radiographic tube (Heliodent DS, Sirona Dental Systems GmbH, Bensheim, Germany). The radiographic unit was operated at 60 kilovolts and 7
milliamperes. The exposure time varied between
.4 and .8 seconds, depending on the type of tooth.
The clinicians asked the subjects to contact
them immediately if pain developed in the
affected teeth. Unless a subject had an acute

episode of pain, recall examinations for each tooth

took place at six and 12 months to determine clinical and radiographic signs of AP and integrity of
the restoration. At each recall appointment, the
clinicians obtained a periapical radiograph using
the custom bite block fabricated at the initial
appointment to assess periapical status radiographically. They also evaluated the integrity of
the restoration clinically and repaired it if necessary. Patients with pain were given the option to
undergo either complete endodontic treatment or
extraction. Those whose teeth remained asymptomatic after 12 months were strongly advised to
have complete endodontic treatment done as soon
as possible.
Image analysis. We analyzed radiographs
using computerized densitometric ratio analysis
(as described by Kerosuo and rstavik,14 Delano
and colleagues15 and Pettiette and colleagues16)
after digitization and registration of each set of
radiographs, which consisted of immediate (baseline), six-month recall and 12-month recall postoperative radiographs. We digitized these as
eight-bit depth (256 gray levels) images in which
0 = black and 255 = white. For each image set, we
delineated and measured an area of likely AP formation and a proximate healthy and normal, or
N, area (Figure). We then calculated the mean
gray levels ratio of AP/N. In calculating mean
change in gray-level ratios between baseline and
recall postoperative images, we determined that
unchanged and positive values ( 0) represented health and negative values ( < 0) represented the presence of AP. One of the investigators (E.O.D.) performed all radiographic analyses.
Statistical significance was set at = .05.
RESULTS

The material for this study consisted of 73 treated

premolars and molars.
Interim pain relief. Of 73 teeth, we
accounted for 52 (71 percent) at the six-month
recall and 40 (55 percent) at the 12-month recall.
Five (10 percent) of the 52 six-month recall teeth
required additional endodontic therapy owing to
continued acute pulpitis. The patients involved
complained of continuous pain, and they received
additional therapy as late as 45 days after initial
treatment. These teeth were considered as
immediate failures because of the fact that initial treatment failure was diagnosed before the
first scheduled recall visit.
The distribution of teeth by group in relation to

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1709

R E S E A R C H

immediate and late failures made up the nine

teeth that became painful during the 12-month
period. We found no statistical difference between
groups with a two-tailed Fisher exact test
(P = .48).
The overall success rate in pain prevention
dropped from 90 percent at six months to 78 percent at 12 months, as shown in Table 1.
Radiographic assessment (AP). Our image
analysis is exclusive of teeth in subjects who
experienced pain, swelling or both that required
definitive treatment before a recall. We defined
radiographic success as a maintained periapical
status indicated by densitometric analysis. The
group distribution of recall images can be seen in
Table 2.
Statistical analysis with t test (P = .82) showed
no difference in AP/N between groups at baseline,
Figure. Periapical image of one of the patients showing
and 2 analysis also showed no difference in
delineation of areas of interest. This was one of two
change () at both the six-month recall (P = .42)
patients who had two teeth recruited in the study. Tooth
no. 18 was restored with an IRM base with glass ionomer
and the 12-month recall (P = .61). The six-month
core (Fuji IX GP, GC America, Alsip, Ill.) and no. 19 with
recall image analysis showed that 49 percent of
Caulk IRM (Dentsply Caulk, Milford, Del.). N: Normal
the pain-free teeth were successful at mainarea. AP: Area of likely apical periodontitis formation.
taining ( 0) periapical status. This dropped to
pain relief can be seen in Table 1.
42 percent at 12 months.
By six months, we found no statistical differIntegrity of restoration. We made the evaluence in pain between groups with a two-tailed
ation of the wear characteristics of the two
Fisher exact test (P1.0).
restorative groups on the basis of the observed
We diagnosed an additional four teeth with
need for repair or replacement of the restoration
acute pulpitis and/or AP after the six-month
on or before the scheduled recall appointments.
recall, when the patients came in with complaints
We noted defective restorations requiring repair
of pain and swelling. We termed these teeth late
of one tooth each in Group I and Group II at the
failures, since initial pulp therapy rendered the
six-month recall.
patient asymptomatic for at least six months. The
By 12 months, an additional six in Group I and
three in Group II required
TABLE 1
repair, resulting in a
restorative success rate of
INTERIM PAIN RELIEF AT SIX- AND 12-MONTH RECALLS.
68 percent for Group I and
78 percent for Group II, as
TREATMENT GROUP
n
PAIN (%)
NO PAIN (%)
seen in Table 3. 2 analysis
SIX-MONTH RECALL
showed no statistical differ89
11
27
ence (P = .32) between
I*
groups at 12 months.

92
8
25
II
10

90

Combined

52

22

27

73

II

18

17

83

Combined

40

22

78

12-MONTH RECALL

* Group I received restorations of intermediate restorative material (Caulk IRM, Dentsply Caulk, Milford,
Del.).
Group II received restorations of intermediate restorative material base with glass ionomer core
(Fuji IX GP, GC America, Alsip, Ill.).

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JADA, Vol. 135, December 2004

Copyright 2004 American Dental Association. All rights reserved.

DISCUSSION

The success rate for the

pulpotomy treatment in
regard to pain relief was 90
percent at six months and
dropped to 78 percent at 12
months. This is similar to
Hasselgren and Reits1 success rate of 96 percent in 30

R E S E A R C H

TABLE 2
days. The extended period
in our study potentially
CHANGE IN PERIAPICAL STATUS AT SIX- AND 12-MONTH
was long enough to allow
RECALLS.
for bacterial leakage and
subsequent inflammation
TREATMENT GROUP
n
<* 0 (%)
0 (%)
of the remaining pulp11,17
SIX-MONTH RECALL
and, therefore, the reasonably expected drop in suc56
44
18
I
cess rate with time. There

42
58
19
II
was no significant differ49
51
37
Combined
ence between groups, but
12-MONTH
RECALL
there was a 10 percent difference at the 12-month
38
10
16
I
assessment with a pain47
8
15
II
free rate of 83 percent for
Group II and 73 percent for Combined
42
18
31
Group I (Table 1). This
* < : A reduced densitometric ratio indicating deteriorating periapical status.
: An unchanged or increased densitometric ratio indicating a stable periapical status.
may be related to the fact
I received restorations of intermediate restorative material (Caulk IRM, Dentsply Caulk, Milford,
that there was less damage Group
Del.).
Group II received restorations of intermediate restorative material base with glass ionomer core
in the hybrid restorations
(Fuji IX GP, GC America, Alsip, Ill.).
in Group II. Two of the five
immediate failures had
TABLE 3
vertical root fracture, and
fracture lines were noted at
STATUS OF CORONAL RESTORATION OVER 12 MONTHS.
the time pulpotomy was
carried out. Two (one each
TREATMENT GROUP
n
REPAIRED (%)
INTACT (%)
in Groups I and II) of the
SIX-MONTH RECALL
four late failures did not
96
4
27
I*
show up at the six-month
96
4
25
II
follow-up but were manifested in defective restora12-MONTH RECALL
tions along with pain and
68
32
22
I
swelling before the 1278
22
18
II
month follow-up.
Since chronic AP may be * Group I received restorations of intermediate restorative material (Caulk IRM, Dentsply Caulk, Milford,
Del.).
painless, we elected also to
Group II received restorations of intermediate restorative material base with glass ionomer core
monitor the periapical
(Fuji IX GP, GC America, Alsip, Ill.).
status of the treated teeth
radiographically by means
of a deteriorated periapical status would have
of computerized image analysis. This has been
increased at both recalls. At 12 months, the major
shown to detect subtle osseous changes15 and is
an objective and reliable means of assessing pericontribution to failure in the sample came from
apiacal osseous change14,15 on the basis of histoGroup I (Table 2); again, this may be attributed to
logic correlation.18 Only asymptomatic teeth were
the higher loss of coronal integrity among Group I
included in radiographic assessment, as those
than among Group II. At the 12-month recall, 32
that had become painful had undergone further
percent of coronal restorations in Group I showed
management. In such cases, the patient must be
damage compared with 22 percent in Group II.
made aware that the absence of symptoms does
It may appear from a clinical perspective that
not mean that the disease has been arrested, and
after pulpotomy, a restoration of an IRM base
that this may affect the prognosis of final
with a Fuji IX core had superior extended wear
endodontic treatment. If it is assumed that immecharacteristics compared with an IRM restoration
diate and late failures in our study would have
alone. However, we did not observe a statistically
been so affected, we can predict that the incidence
significant difference between the two treatments.

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1711

R E S E A R C H

CONCLUSION

In conclusion, on the basis of our findings, either

a restoration of an IRM base with a Fuji IX core
or an IRM alone is adequate for periods of six
months or 12 months after pulp therapy. These
treatments appear to be viable alternatives to
extraction for patients who wish to maintain a
tooth with irreversible pulpitis but cannot afford
the ideally recommended complete endodontic
therapy at the time of diagnosis. Each of these
alternative therapies should be presented to the
patient as an interim form of management, the
use of which should not exceed a period of 12
months. During the time that this alternative
therapy offers, it is feasible that the patients
financial situation may improve to the point at
which he or she can continue treatment with complete endodontic therapy. Failure on the patients
part to seek definitive therapy (that is, complete
endodontic therapy and definitive restoration)
after a period of 12 months may result in the
inability to receive complete endodontic therapy
in the future owing to dystrophic calcification of
the pulp space or further breakdown of the
coronal structures. However, we did not observe
this in some of the cases we treated after the
study period.
The hybrid restoration may appear to be more
beneficial in the above-mentioned scenario as well
as for teeth with immature root formation during
apexogenesis and apexification procedures by providing a durable, low-maintenance, bacteria-tight
seal for the duration of the treatment.
Dr. McDougal is in private practice limited to endodontics in
Durham, N.C., and is an adjunct assistant clinical professor, Department of Endodontics, University of North Carolina at Chapel Hill
School of Dentistry. At the time the study described here was conducted, he was an endodontic resident at the University of North Carolina at Chapel Hill School of Dentistry.
Dr. Delano is in private practice limited to endodontics in Christiansted, St. Croix, U.S. Virgin Islands, and is an adjunct assistant
clinical professor, Department of General Dentistry and Diagnostic Science, University of North Carolina at Chapel Hill School of Dentistry.
At the time the study described here was conducted, he was an
endodontic resident at the University of North Carolina at Chapel Hill

1712

School of Dentistry. Address reprint requests to Dr. Delano at P.O. Box

6073, Christiansted, St. Croix 00823-6073, U.S. Virgin Islands, e-mail
rootcanal@vipowernet.net.
Dr. Caplan is an associate professor, Department of Dental Ecology,
University of North Carolina at Chapel Hill School of Dentistry.
Dr. Sigurdsson is in private practice limited to endodontics in Reykjavik, Iceland. At the time the study described here was conducted, he
was the program director, Endodontics, University of North Carolina at
Chapel Hill School of Dentistry.
Dr. Trope is J.B. Freedland Professor and the chair, Department of
Endodontics, University of North Carolina at Chapel Hill School of
Dentistry.
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11. Blaney TD, Peters DD, Setterstrom J, Bernier WE. Marginal
sealing quality of IRM and Cavit as assessed by microbiol penetration.
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12. Hembree JH Jr, Andrews JT. Microleakage of several class V
anterior restorative materials: a laboratory study. JADA 1978;97(2):
179-83.
13. Lynch E, Tay WM. Glass-ionomer cements: part 4clinical properties III. J Ir Dent Assoc 1989;35(2):75-82.
14. Kerosuo E, rstavik D. Application of computerised image analysis to monitoring endodontic therapy: reproducibility and comparison
with visual assessment. Dentomaxillofacial Radiol 1997;26(2):79-84.
15. Delano EO, Ludlow JB, rstavik D, Tyndall D, Trope M. Comparison between PAI and quantitative digital assessment of apical healing
after endodontic treatment. Oral Surg Oral Med Oral Pathol Oral
Radiol Endod 2001;92(1):108-15.
16. Pettiette MT, Delano EO, Trope M. Evaluation of success rate of
endodontic treatment performed by students with stainless-steel
K-files and nickel-titanium hand files. J Endod 2001;27(2):124-7.
17. Bergenholtz G. Effect of bacterial products on inflammatory reactions in the dental pulp. Scand J Dent Res 1977;85(2):122-9.
18. Delano EO, Tyndall D, Ludlow JB, Trope M, Lost C. Quantitative
radiographic follow-up of apical surgery: a radiometric and histologic
correlation. J Endod 1998;24:420-6.

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