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Abstract
Introduction: The present study reports the results of a
randomized clinical trial comparing local intraosseous
methylprednisolone injection and emergency pulpotomy
A lthough treatment of acute pulpitis is now well-managed, emergency manage-
ment of this usually painful condition may constitute an unanticipated and sig-
nificant workload that disrupts the normal workflow in a dental office or clinic.
in the management of acute pulpitis on efficacy, safety, Emergency pulpotomy is widely recognized as either the reference procedure for
and efficiency end points. Methods: After providing managing of this type of emergency (1) or as an efficient alternative to impractical
prior informed written consent, 94 patients consulting total pulpal extirpation (2).
for acute irreversible pulpitis pain at university- However, the superiority of these 2 approaches appears to be based on insufficient
affiliated teaching hospital dental clinics in Dakar, evidence. Whereas some reference studies have compared various therapeutic pulpot-
Senegal were randomly assigned to either the methyl- omy modalities, we were unable to find a randomized comparison of this procedure
prednisolone treatment group (n = 47) or the pulpotomy with another emergency protocol in the literature. Furthermore, pulpotomy requires
treatment group (n = 47). Patients were followed up at the collaboration of a dentist who is competent in endodontics as well as significant
1 week and assessed 6 months later to evaluate the technical setup and sufficient time.
therapeutic outcome of their treatment. Results: At Previous studies have highlighted the possibility of obtaining mid-term (a few
day 7 the patients in the methylprednisolone group re- weeks) pain relief by using a pharmacologic approach, thereby allowing planned
ported less intense spontaneous and percussion pain endodontic management of the causal disease. Among these studies, a double-
in the day 0–day 7 period than the patients in the pul- blinded, randomized trial (versus a physiological serum placebo) demonstrated
potomy group. Methylprednisolone treatment took the anti-inflammatory effects of intraosseous glucocortocoid injection and suggested
approximately 7 minutes (4.6–9.3) less to accomplish that clinically satisfactory pain relief could be obtained by using a pharmacologic
than pulpotomy (or about half the time). No difference approach (3). However, the cohort studied in this report was too small to assess
in the therapeutic outcome was found between the 2 the safety of this procedure. Furthermore, the control used in this study was a pla-
treatment groups at 6 months (all credible intervals cebo, which did not permit evidence-based comparison of intraosseous glucocorti-
span 0). Conclusions: This study establishes that coid injection with the emergency pulpotomy reference procedure. Therefore, we
methylprednisolone injection for acute pulpitis is designed a randomized clinical trial that was able to determine whether this phar-
relieved by a minimally invasive pharmacologic macologic approach was as effective as emergency pulpotomy in the management of
approach more effectively than by the reference pulpot- acute pulpitis as well as assessing whether it was safe to use. Our study did not aim
omy and conserves scarce dental resources (ie, end- to explain the physiological and pharmacologic mechanism(s) of the use of
odontic equipment and supplies, dental surgeon’s methylprednisolone injection for acute pulpitis pain.
time). (J Endod 2016;42:2–7)
tooth. Therefore, the intention-to-treat analysis coincides with the recovered uneventfully and was followed up at 7 days and 6 months.
effective-treatment analysis. Patient flow is illustrated in Figure 1. Her pain records were imputed maximal values for days 1–4 and were
There were some minor imbalances between the groups. Pre- model-imputed afterwards. One patient in the experimental group re-
intervention intergroup differences are tabulated in Supplemental ported headache and hot flashes at day 7. She was referred to a cardi-
Table S1 (available online at www.jendodon.com) (patient character- ologist, who was unable to diagnose the reported problem; therefore,
istics) and Table 1 (teeth characteristics) and illustrated in one cannot confirm or deny a causal link to the experimental
Supplemental Figure S1 (available online at www.jendodon.com). treatment.
Pre-treatment pain duration was shorter and the percussion pain score Ten patients were lost to follow-up. Five patients presented at day 7
was higher in the methylprednisolone (experimental) group (their 95% with unfilled or illegible pain records; these values were model-
credible intervals do not contain 0). The other patients’ characteristics imputed.
were well-matched between the groups. During the 7-day waiting period (raw results in Table 3, analysis in
Early treatment results are tabulated in Table 2 and illustrated in Supplemental Table S2 (available online at www.jendodon.com), illus-
Supplemental Figure S2 (available online at www.jendodon.com). The trated in Fig. 2), less percussion pain was reported by patients in the
time required to accomplish methylprednisolone treatment was about experimental group in which spontaneous pain tended to be less
7.3 minutes (ie, 7.0 minutes less than pulpotomy). Immediately after intense, but the 95% credible interval for spontaneous pain (barely)
treatment, both spontaneous pain and percussion pain were less intense contains 0. It should be noted that the summary indices SPI, which
in the methylprednisolone experimental (experimental) group. do not account for intrapatient correlations, were sharply smaller in
On day 4, one patient in the methylprednisolone group presented the experimental group; conversely, the SPID indices (indices for relief
with complaints of unbearable pain. After pulpotomy, the patient of the initial pain) were sharply greater in the experimental group. One
NA, not available; Pseudo p, probability of a coefficient having a sign inverse of its median; SPI, sum of pain intensities; SPID, sum of pain intensity differences.
also notes that whereas percussion pain and spontaneous pain in the Supplemental Figure S2 (available online at www.jendodon.com). No
control group decreased from day 1 to day 4 and leveled off afterwards, sharp imbalance exists between groups. However, a trend toward fewer
spontaneous pain in the experimental group was diminished at day 4 periapical lesions and endodontic retreatment indications was observed
and elevated at day 5. in the experimental group.
At day 7 (Table 4 and Supplemental Figure S2; available online at
www.jendodon.com), it was noted that both spontaneous and percus-
sion pain were less in patients in the experimental group. Other day 7 Discussion
results were well-matched between the groups. Management of acute irreversible pulpitis by pulpotomy in
All patients seen at day 7 were also followed up at 6 months; results mature permanent teeth is widely recommended when the reference
obtained at 6 months are tabulated in Table 4 and illustrated in etiologic treatment (endodontic treatment) cannot be done
TABLE 3. Raw Spontaneous and Percussion Pain Reported by Patients during the 7-day Waiting Period
Pain intensity
Variable Day 0 1 2 3 NA 0 1 2 3 NA
Spontaneous pain 1 18 14 6 1 8 10 20 10 0 7
2 20 18 0 1 8 10 26 4 0 7
3 20 17 1 1 8 13 24 2 1 7
4 35 3 0 1 8 19 17 2 2 7
5 29 7 1 1 9 23 14 2 1 7
6 32 6 0 0 9 24 15 0 1 7
7 34 4 0 0 9 24 15 0 1 7
Percussion pain 1 21 16 1 1 8 1 23 14 2 7
2 27 11 0 1 8 1 27 11 1 7
3 30 8 0 1 8 4 31 5 0 7
4 34 4 0 1 8 7 30 2 1 7
5 32 6 0 0 9 7 30 3 0 7
6 31 7 0 0 9 9 29 1 1 7
7 31 7 0 0 9 11 26 2 1 7
Methylprednisolone Pulpotomy
Randomization group
NA, not available.
Pain intensity measurement is described in text.
Figure 2. Pain daily variations during 7-day waiting period, illustrated by the polychoric ordered regression parameters’ posterior distributions. Box = 50%
highest posterior density (HPD) region (here always an interval), whiskers = 95% HPD interval, bar = median.
immediately (2). Some case series document the success rate of To the best of our knowledge, this trial is the first clinically
pulpotomy during sometimes extended periods (5–7). Most oriented, randomized comparison of pulpotomy with an alternative
notably, Tronstadt (1) justifies the recommendation of pulpotomy treatment. The seminal work of Gallatin et al (3) did not allow for
as the reference emergency management for acute irreversible pul- comparison of the clinical effects of pulpotomy and methylprednis-
pitis on the basis of a series of 1848 cases, for which 98% success olone injection. However, it demonstrated that the latter treatment
rate is claimed. was not a placebo effect and hinted at an important pain relief ef-
However, randomized clinical comparisons involving pulpotomy fect. This clinical effect of methylprednisolone has been associated
are rare and compare different modalities of realization of a pulpotomy: with a drop in intrapulpal prostaglandin E2 concentration 1 day af-
ter injection (11). Similar pharmacologic mechanisms have been
1. Various temporary interim medications were compared in a small proposed to explain the effectiveness of 30 mg preoperative pred-
randomized, 6-armed clinical trial (8), which turned out to be nisolone administration per injection on postoperative pain in end-
inconclusive but allowed the authors to report a high probability odontics (12).
of pain relief after pulpotomy (93% at day 7). Our results suggest that pulpotomy results in a short episode of
2. Two temporary restorative materials were compared in medium- periodontitis, objectified by percussion pain, which does not occur after
term (6 and 12 months) restoration after pulpotomy (9). These au- methylprednisolone administration.
thors found no differences in sealing tightness between the materials The unavailability (for logistical reasons) of interim statistical an-
but noted the clinical success rate of pulpotomy after a long interim alyses led to the inclusion of 47 patients per group, resulting in a slightly
period (90% at 6 months.) overpowered trial. Similar reasons prevented us from recording anal-
3. The effect of intrasulcular ketorolac tromethamine injection was gesic consumption, which might have been a better indicator of pain
compared with a placebo as a preliminary to ‘‘pulp extirpation’’ than self-reported estimations.
in a small randomized trial, which was terminated early (10). The Our results show that methylprednisolone injection appears to
authors decided to interrupt the trial because the ketorolac injection be more effective than pulpotomy for relief of acute irreversible pul-
was itself quite painful. In addition, the trial did not provide details of pitis pain. They also provide limited proof that it is safe to use,
the endodontic procedure results. because no seriously dangerous event related to its use was reported.
The only undesirable event observed, which turned out to be incon- Supplementary Material
sequential, appears to be similar to effects reported in rheumatology Supplementary material associated with this article can be
(13). However, the small cohort size of this study makes it impos- found in the online version at www.jendodon.com (http://dx.doi.
sible to rule out the possibility of rare but severe events. Finally, org/10.1016/j.joen.2015.09.003).
our results suggest that no mid-term (up to 6 months) ill effects
were reported to result from this procedure. Its long-term effects
remain to be assessed. References
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The authors deny any conflicts of interest related to this study. 28:749–56.