ORIGINAL RESEARCH

https://doi.org/10.5005/jp-journals-10063-0132
CODS Journal of Dentistry
Volume 14 | Issue 1 | Year 2022

A Randomized Clinical Trial on Oral and Transdermal Diclofenac on Controlling Postoperative Endodontic Pain

Brindhu Murugan1, Saravana Arun Kumar2, Krishnappan Srinivasan3, Naseeba Akbar Ali4, Elavarasu Prem Kumar5, Nanitha Lakshmi6

1,2,5Department of Conservative Dentistry and Endodontics Mahatma Gandhi Postgraduate Institute of Dental Sciences, Puducherry, India

3,4Department of Periodontology Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth University, Puducherry, India

6Department of Oral Medicine and Radiology, Mahatma Gandhi Postgraduate Institute of Dental Sciences, Puducherry, India

Corresponding Author: Saravana Arun Kumar, Department of Conservative Dentistry and Endodontics Mahatma Gandhi Postgraduate Institute of Dental Sciences, Puducherry, India, Phone: +91 9566668036, e-mail: arunkumarsep92@gmail.com

Received on: 19 July 2022; Accepted on: 29 December 2022; Published on: 02 March 2023

ABSTRACT

Aim: To compare the effect of analgesics on postoperative pain following single-visit root canal treatment in patients with symptomatic irreversible pulpitis.

Materials and methods: In this randomized controlled clinical trial, 80 patients with symptomatic irreversible pulpitis of posterior teeth without any signs and symptoms of acute or chronic apical periodontitis and moderate to severe pain were divided into four groups of 20 patients each enrolled in this study. They are group I, pretreatment oral diclofenac; group II, pretreatment transdermal diclofenac; group III, posttreatment oral diclofenac; and group IV, posttreatment transdermal diclofenac. Immediately a single-visit root canal treatment is performed. The intensity of the pain was scored based on a 10-point visual analogue scores (VAS) before and after treatment for up to 24 hours postoperatively. Data were submitted for statistical analysis. Kruskal–Wallis test was performed to compare the pain scores between the four groups and the Mann–Whitney U test to test the significance between the groups.

Result: At 24 hours interval postoperative after drug administration, the intensity of the pain was lower when compared to baseline values. Group IV showed significant results at 24 hours when compared to group III; no significant difference was seen between groups I and III.

Conclusion: The results demonstrate that a posttreatment transdermal patch may be more effective than oral diclofenac for the management of postoperative endodontic pain.

How to cite this article: Murugan B, Kumar SA, Srinivasan K, et al. A Randomized Clinical Trial on Oral and Transdermal Diclofenac on Controlling Postoperative Endodontic Pain. CODS J Dent 2022;14(1):6-10.

Source of support: Nil

Conflict of interest: None

Keywords: Diclofenac patch, Diclofenac transdermal patch, Irreversible pulpitis, Postoperative endodontic pain, Single-visit root canal treatment.

INTRODUCTION

Diclofenac is the most commonly given nonsteroidal anti-inflammatory drug (NSAID), which has anti-inflammatory, analgesic, and antipyretic properties.

Recently, diclofenac transdermal patches have been developed as an innovative topical drug delivery system, offering the advantage of using sustained drug delivery5 with fewer incidences of systemic adverse effects due to low plasma concentrations.

The study was done to measure postoperative endodontic pain using oral and transdermal diclofenac transdermal patches.

RATIONALE

The purpose of this randomized clinical trial was to investigate the pretreatment and posttreatment analgesia effect of the tab. Diclofenac and the transdermal patch of diclofenac for controlling postoperative pain in patients with irreversible pulpitis cases.

OBJECTIVE

Evaluate postoperative endodontic pain after 24 hours.

MATERIALS AND METHODS

Eligibility Criteria

Selection of cases—a total of 80 patients participated in the controlled clinical trial that was approved by the Institutional Ethical Committee and consent from the participants.

Patients were selected based on the following criteria:

Inclusion criteria as follows:

  • 18–45 years of age.

  • Posterior teeth.

  • Irreversible pulpitis.

  • Pain score ranging from moderate to severe.4-10

  • Informed consent was obtained.

Exclusion criteria are as follows:

  • <18 years and >45 years.

  • Allergic to NSAIDs.

  • Pregnant women.

  • Gastrointestinal disorder.

  • Patients taking analgesic <12 hours.

  • Calcified canals.

  • Periodontal pathosis.

A pilot study was performed on 40 patients by means of the one-way analysis of variance using G*Power 3.2 version. Moderate to severe pain patients were selected for the study.

The pilot study resulted in a total sample size of 80 cases (n = 20). A total of 20 patients for each group.

The clinical trial has been registered with the Scientific Review Board with reference number SRB/SDMDS11/18/ENDO/06. After an explanation of the treatment procedures, each patient was anesthetized with 2 mL of lidocaine, followed by isolation and canal opening. Cleaning and shaping were done using the passive step-back technique to enlarge the canal to a minimum apical size of #35 file or larger, depending on the size of the canal. Sodium hypochlorite (2.5%) and normal saline were used as irrigants.

Finally, canals were dried with paper points and obturated using gutta-percha cones and AH Plus sealers. Each patient was provided with a postoperative pain questionnaire having VAS. Patients were encouraged to make immediate postoperative pain measurements (0 h), once treatment is over in order to ensure patient understanding of the pain questionnaire.

Patients who signed the informed consent were randomly divided into four groups, patients receiving oral diclofenac 50 mg and transdermal diclofenac. The block randomization was done by using a computer-generated randomization block by a trained dentist who was blinded. Following the completion of root canal treatment, the investigator collected the forms; the drugs were administered. The root canal treatment was done by a single operator after their training and calibration. Strict instructions, however, were given to the patients not to take the rescue medication until first speaking with the investigator. They were then requested to take the rescue if the medication was not taken by the patient and was told to return it at their next appointment.

Transdermal Patch Application

Preparing

  • Prepare and clean the skin to remove any dirt, lotions, oils, or powders. Clean the skin using warm water alone or with a clear soap.

  • Take the patch out of the packaging.

  • Place the patch, sticky side down, onto the clean area of skin.

Complication of Transdermal Patch

Moderate irritation, itching, or redness at the application site may also occur.

Pharmacokinetics

The diclofenac epolamine topical patch (patch, 10 × 14 cm; Pfizer Inc., New York, United States of America) is a topical patch containing 1.33% diclofenac epolamine.

Assessment of Pain following Root Canal Treatment
Trade names Content of the medication Groups Manufacturers
Tablet diclofenac 50 mg Diethylamine Group I Micro labs Limited, Bangalore, India
Transdermal diclofenac patch Diclofenac diethylamine 100 mg, excipients Group II Zuventus Healthcare, Mumbai, Maharashtra, India
Tablet diclofenac 50 mg Diethylamine Group III Micro labs Limited, Bangalore, Karnataka, India
Transdermal diclofenac patch Diclofenac diethylamine 100 mg, excipients Group IV Zuventus Healthcare, Mumbai, Maharashtra, India

RESULTS

Statistical Analysis

  • The Normality tests, Kolmogorov–Smirnov, and Shapiro–Wilk test results reveal that all variables do not follow a normal distribution. Therefore, nonparametric tests were applied to analyze the data.

  • Data was entered in a Microsoft Excel spreadsheet and analyzed using Statistical Package for the Social Sciences software (version 21).

  • For the test, a p-value of < 0.05 is to be considered statistically significant.

  • Descriptive analysis was performed.

  • Wilcoxon signed-rank test—to assess the difference between the pretreatment and posttreatment VAS scores within the treatment groups.

  • Kruskal–Wallis test—to compare the difference in the pretreatment and posttreatment VAS scores between the treatment groups.

Table 1 depicts the visual analogue scores (VAS) among various groups pre and posttreatment. The mean VAS score was recorded pre and posttreatment among the study subjects in all the groups. The highest mean VAS pretreatment was recorded in study subjects belonging to group IV (7.90 ± 0.87). However, the highest mean VAS posttreatment were recorded in study subjects belonging to group I (3.70 ± 0.67).

Table 1: Descriptive statistics
VAS score Group I Group II Group III Group IV
Pretreatment 7.60 ± 1.17 7.60 ± 0.96 7.60 ± 0.69 7.90 ± 0.87
Posttreatment 3.70 ± 0.67 3.40 ± 0.51 2.60 ± 0.69 2.50 ± 0.52

Table 2 depicts the comparison of mean VAS pre and posttreatment within the treatment groups. The difference in mean VAS score between pre and posttreatment was the highest for group IV (5.40 ± 1.07), followed by group III (5.00 ± 1.15), group II (4.20 ± 0.91), and the least reduction was found in the group I (3.90 ± 1.28). However, the differences between the VAS score pre and posttreatment in all the groups were highly significant (p < 0.05), indicating a significant pain reduction across all four groups.

Table 2: Comparison of mean VASs pre and posttreatment within the treatment groups
Group VAS score [mean ± standard deviation (SD)] Mean difference Z-value p-value
Pretreatment Posttreatment
Group I 7.60 ± 1.17 3.70 ± 0.67 3.90 ± 1.28 −2.829 0.005
Group II 7.60 ± 0.96 3.40 ± 0.51 4.20 ± 0.91 −2.850 0.004
Group III 7.60 ± 0.69 2.60 ± 0.69 5.00 ± 1.15 −2.825 0.005
Group IV 7.90 ± 0.87 2.50 ± 0.52 5.40 ± 1.07 −2.827 0.005

p-value < 0.05 is considered statistically significant; Wilcoxon signed-rank test

Table 3 depicts the comparison of pre and posttreatment mean VASs among the treatment groups. The highest mean VAS pretreatment was recorded in study subjects belonging to group IV (7.90 ± 0.87) when compared to the other three groups. However, there was no significant difference in the pretreatment VAS scores across the four groups. The highest mean VAS posttreatment were recorded in study subjects belonging to group I (3.70 ± 0.67), indicating the least reduction in pain when compared to the other three groups. The difference between the posttreatment VAS scores across the four groups was statistically highly significant.

Table 3: Comparison of pre and posttreatment mean VASs among the treatment group
VAS score (mean ± SD) Groups Chi-square p-value
Group I Group II Group III Group IV
Pretreatment 7.60 ± 1.17 7.60 ± 0.96 7.60 ± 0.69 7.90 ± 0.87 0.708 0.871
Posttreatment 3.70 ± 0.67 3.40 ± 0.51 2.60 ± 0.69 2.50 ± 0.52 17.349 0.001

p-value < 0.05 is considered statistically significant; p-value < 0.001 is considered statistically highly significant; Kruskal–Wallis test

Pretreatment pairwise comparisons were not made because Kruskal–Wallis test did show any statistically significant difference between the pretreatment VAS scores of the groups.

Table 4 depicts the pairwise comparisons of mean VASs between the treatment groups posttreatment. The difference between the posttreatment VAS scores of group I vs II and group III vs IV showed no significant difference. This indicates that there is no significant difference in the effect of these groups on posttreatment pain.

Table 4: Pairwise comparisons of mean VASs between the treatment groups posttreatment
VAS score Groups Mean difference Chi-square p-value
Posttreatment Group I vs II 0.30 ± 1.05 3.450 0.47
Group I vs III 1.10 ± 1.10 15.050 0.002
Group I vs IV 1.20 ± 0.91 16.500 0.001
Group II vs III 0.80 ± 0.91 11.600 0.017
Group II vs IV 0.90 ± 0.73 13.050 0.007
Group III vs IV 0.10 ± 0.56 1.450 0.76

Pairwise comparisons—Kruskal–Wallis test; p-value < 0.05 is considered statistically significant; p-value < 0.001 is considered statistically highly significant

There were significant differences in the posttreatment VAS of group I vs III and group I vs IV. Group III and IV had lesser VAS score posttreatment, indicating a superior effect on pain reduction when compared to group I. Similarly, group II vs III and group II vs IV showed a significant difference in the VAS scores posttreatment. Groups III and IV were significantly superior in their effect to reduce pain posttreatment when compared to group II.

Figure 1 depicts the pretreatment mean VASs among the treatment groups. The highest mean VAS pretreatment was recorded in study subjects belonging to group IV (7.90 ± 0.87) when compared to the other three groups.

Fig. 1: Mean VASs pretreatment among the treatment groups

However, there was no significant difference in the pretreatment VAS scores across the four groups.

Figure 2 depicts the posttreatment mean VASs among the treatment groups. The highest mean VAS posttreatment were recorded in study subjects belonging to group I (3.70 ± 0.67), indicating the least reduction in pain when compared to the other three groups. The difference between the posttreatment VAS scores across the four groups was statistically highly significant.

Fig. 2: Mean VASs posttreatment among the treatment groups

Figure 3 depicts the comparison of mean VASs pre and posttreatment within the treatment groups. The difference in mean VAS score between pre and posttreatment was the highest for group IV (5.40 ± 1.07), followed by group III (5.00 ± 1.15), group II (4.20 ± 0.91), and the least reduction was found in group I (3.90 ± 1.28). However, the differences between the VAS score pre and posttreatment in all the groups were highly significant (p < 0.05), indicating a significant pain reduction across all four groups.

Fig. 3: Mean VASs pre and posttreatment among the treatment groups

DISCUSSION

Protocols for assessing endodontic pain differ from oral surgery models in several respects. Patients in need of endodontic treatment might have different systemic conditions and might vary in age or the degree of pulpal pathology; these factors could introduce bias into a study.

Periapical anatomy is another important factor that can lead to different inflammatory responses after root canal therapy. Thus, the evaluation of analgesic and anti-inflammatory drugs in oral surgical procedures cannot be directly extrapolated for determining the appropriate approach to treat endodontic pain.

This was one of the pioneer studies to use a preoperative single oral dose of diclofenac sodium for the control and prevention of postendodontic pain. Oral administration was preferred because the technique is clinically effective and convenient; the use of intramuscular or intravenous injection may lead to discomfort and fear and is not well accepted by some patients.1-8

Most patients and dentists would prefer to provide an anti-inflammatory agent to be taken immediately before or self-administered as needed by the patient after anesthesia has worn off. However, in the present research, diclofenac sodium was administered 30 minutes before the conventional root canal therapy. The primary mechanism responsible for its anti-inflammatory, antipyretic, and analgesic actions is the inhibition of prostaglandin synthesis by the inhibition of cyclooxygenase. Diclofenac may also be a unique member of the NSAIDs. There is some evidence that diclofenac inhibits the lipoxygenase pathways, thus reducing formation of the leukotrienes (also pro-inflammatory autacoids).

However, there are few clinical trials (involving endodontic and oral surgery procedures) that evaluate the optimal moment for oral analgesic/anti-inflammatory agent administration. Certain studies report preoperative prescriptions ranging in duration from 1 to 12 hours.5-18 This randomized trial allowed sufficient comparison between groups. The sample was distributed similarly regarding age, gender, and teeth to avoid bias. Although certain studies have shown a relationship between preoperative and postoperative pain.11,19-26

Further, future clinical trials are required to show the efficacy of pretreatment analgesics to prevent postendodontic pain.

CONCLUSION

Posttreatment transdermal decreased postoperative endodontic pain when compared to pretreatment and posttreatment oral diclofenac at 24 hours. Pretreatment transdermal diclofenac showed significantly higher VAS scores compared to other groups. Suggest that pretreatment transdermal diclofenac might not have a high affinity for the inflammatory components of endodontic pain in comparison to posttreatment transdermal. None of the medications showed any higher incidence of side effects and were relatively safe.

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