|Year : 2012 | Volume
| Issue : 1 | Page : 19-23
Efficacy of ibuprofen and paracetamol and diclofenac sodium and paracetamol combination on postoperative pain following root canal preparation in a randomized placebo-controlled study
Sameer Makkar, Nisha Kaler, Rajan Dhawan, Navjot Mann, Shinam Pasricha
Department of Conservative Dentistry and Endodontics, National Dental College & Hospital, Dera Bassi, India
|Date of Web Publication||27-Sep-2012|
Department of Conservative Dentistry and Endodontics, National Dental College & Hospital, Dera Bassi, Mohali, Punjab
Aim: To compare the efficacy of two different oral analgesic combinations on postoperative pain following root canal preparation in teeth with irreversible pulpitis.
Materials and Methods: In this in-vivo study, 30 patients who were diagnosed with irreversible pulpitis in anteriors or premolars, having moderate to severe pain were divided randomly into three groups of 10 patients each. The two experimental groups received a single dose of either ibuprofen or paracetamol or diclofenac sodium and paracetamol combination while the control group received placebo medication, immediately after the first appointment where the pulp was extirpated and canals were fully prepared. The intensity of pain was recorded preoperatively and at 6hrs, 12hrs and 24hrs postoperatively using both Visual Analogue Scale (VAS) and Verbal Descriptor Scale (VDS). The data was analyzed statistically.
Result: At 6hrs, 12hrs and 24hrs postoperatively, the intensity of pain was significantly lower in experimental groups than in placebo group. Diclofenac sodium and paracetamol combination was more effective than ibuprofen and paracetamol combination in relieving postoperative pain.
Conclusion: A single oral dose of diclofenac sodium and paracetamol and ibuprofen and paracetamol combination reduced postoperative pain following pulpectomy and root canal preparation of teeth with irreversible pulpitis.
Keywords: Diclofenac sodium, ibuprofen, irreversible pulpitis, paracetamol, postoperative pain
|How to cite this article:|
Makkar S, Kaler N, Dhawan R, Mann N, Pasricha S. Efficacy of ibuprofen and paracetamol and diclofenac sodium and paracetamol combination on postoperative pain following root canal preparation in a randomized placebo-controlled study. Indian J Oral Sci 2012;3:19-23
|How to cite this URL:|
Makkar S, Kaler N, Dhawan R, Mann N, Pasricha S. Efficacy of ibuprofen and paracetamol and diclofenac sodium and paracetamol combination on postoperative pain following root canal preparation in a randomized placebo-controlled study. Indian J Oral Sci [serial online] 2012 [cited 2014 Nov 28];3:19-23. Available from: http://www.indjos.com/text.asp?2012/3/1/19/101671
| Introduction|| |
Root canal treatment is a routine procedure in dentistry and alleviating pain is of utmost importance during treatment procedure. Although dental procedures can be performed without producing pain using local anesthetics, postoperative pain is relatively common especially in patients with preoperative pain. 
Postoperative pain is most likely to occur in the patients within first 24 hours period following root canal treatment.  It occurs because of acute inflammation within the peri-radicular tissue in response to an increase in intensity of stimulants from the root canal.  This prevalence of postoperative pain following root canal treatment has been reported to be 3-58%.  Therefore it is critical for the clinician to minimize or prevent pain by following appropriate treatment regimens supplemented with analgesics where indicated.
The main cause of pain is thought to be due to release of inflammatory mediators that activate sensitive nocioceptors surrounding the tooth.  Therefore non-steroidal anti-inflammatory drugs (NSAIDs) are key drugs to inflammatory pain abatement. NSAIDs are widely available and they have been reported to be effective in managing endodontic pain. 
Several double-blind, placebo- controlled trials in patients with endodontic pain indicate that 400 mg of ibuprofen, 50 mg of ketoprofen, 100mg of flurbiprofen and 30-60mg of ketorolac can all produce significant analgesia when compared to placebos. 
Ibuprofen is one of the most frequently used NSAIDs for control of postoperative pain associated with root canal treatment, and it has good efficacy and safety profile.  Even diclofenac is among the most extensively used NSAID. As the NSAIDs have mainly peripheral nervous system effects, acetaminophen (paracetamol) affects both central and peripheral nervous system. So, a suitable method for controlling moderate to severe pain is to combine two or more drugs. In this way, a lower dose of each drug is used with fewer side effects. The combination of a NSAID and acetaminophen has shown additive analgesia for treating dental pain in several studies. ,
Thus, this placebo-controlled study compares the efficacy of single doses of ibuprofen and paracetamol and diclofenac sodium and paracetamol combination on moderate to severe postoperative pain after instrumentation of root canals.
| Materials and Methods|| |
Thirty patients participated in this prospective, randomized placebo-controlled study that was approved by the Ethical Committee of National Dental College and Hospital, Dera Bassi. All patients were in good health as determined by a health history and oral questioning. Participants were selected consecutively from patients referred to the Department of Conservative Dentistry and Endodontics over a period of two and a half month (from 15 January to 30 March 2012). Patients were considered as potential candidates if they had moderate to severe pain associated with irreversible pulpitis in anteriors and premolars.
Informed consents were obtained from all the patients. Patients were excluded if they fell into any of the following categories-
The intensity of preoperative pain was measured by instructing patient to complete a Visual Analogue Scale (VAS) using a Verbal Descriptor Scale (VDS) as a guide. The markings on the VAS were measured and the degree of pain was categorized as
- Patients younger than 18 years of age
- History of analgesic intake in the previous 12 hrs or other drugs prior to presenting for treatment.
- History of allergy to NSAIDs or local anesthesia.
- Pregnant or nursing women.
- Periodontally compromised teeth.
- Contributory medical history.
Visual Analogue Scale Score 
Verbal Descriptor Scale (VDS) 
- No Pain - 0
- Mild Pain - 0.1 - 3
- Moderate Pain - 3.1 - 6.9
- Severe Pain - 7- 10 [Figure 1]
Treated tooth felt normal, patient did not have any pain.
Recognizable, but not discomforting pain, which required no analgesics.
Discomforting but bearable pain (analgesics if used were effective in relieving pain)
Difficult to bear (analgesics if used were not effective in relieving pain)
The electric pulp vitality test was carried out to diagnose the status of pulp. All patients had just one tooth with irreversible pulpitis.
The standardized procedure for all patients at first visit included local anesthesia, rubber dam isolation, standardized access cavity preparation, and pulp extirpation. The working length was determined at 1mm short from radiographic apex. The canals were prepared with hand instrumentation using crown-down technique. A lubricant, glyde was used to facilitate instrumentation. Copious irrigation with 2.5% sodium hypochlorite followed by saline and 2% chlorhexidine were used between each file. After chemicomechanical preparation, the canals were rinsed thoroughly and dried with paper points. Calcium hydroxide was placed as an intracanal medicament. The teeth were temporized with Cavit (3M ESPE) and the patients were scheduled for next appointment.
Following root canal preparation, each patient was randomly assigned using the Microsoft 2007 Excel program randomization software, to either of the three groups- a control group receiving a single dose of a placebo (Neurobion Forte, tablet of vitamin B complex with B 12 ) and two experimental groups receiving either a single dose of ibuprofen (400mg) and paracetamol (325mg) combination or diclofenac sodium (50mg) and paracetamol (500mg) combination (10 patients in each group). Each patient's medication was inserted into a sealed packet by a nurse, labeled with a random number blinded to both the patient and the clinician.
Patients received a VAS, to record the intensity of pain at 6hrs, 12hrs and 24hrs after the treatment procedure. The patients were instructed not to take any other medication during the investigation. If the postoperative pain was not controlled by the test drug then patients were instructed to contact the clinician and had access to additional analgesics.
If patients had significant swelling or fever, they were seen clinically and proper management was rendered at that time.
At the next scheduled appointment, VAS was collected from all the patients and root canal treatment was completed.
The collected data was analyzed statistically. Wilcoxon signed rank test was used for analyzing data within each group. Kruskal-Wallis ANOVA analysis followed by Mann- Whitney test were used for group-wise comparison. Post hoc test was used for multiple comparisons. All statistical analysis were set with a significance level of P=0.05. According to Mehrvarzfar P. et al the mean difference between the best and the worse response was 2.8 with a standard deviation of 0.8. Using this data, with 95% confidence interval and 80% power, a sample size of 8 subjects per group was required. To compensate for dropouts, 10 subjects per group were included.
| Results|| |
Thirty patients participated in this study. [Table 1]
This data reveals that there were no statistically significant differences among the three groups with regard to gender, age and initial preoperative pain.
One subject from ibuprofen and paracetamol group and one from placebo group took additional analgesics and were excluded from the study. [Table 2]
The mean intensity of postoperative pain in experimental group was significantly lower than that of the control group (P<0.05). At 6hrs postoperatively, diclofenac sodium and paracetamol combination was more effective in relieving pain as compared to ibuprofen and paracetamol combination and placebo drug (P=0.007). At 12hrs and 24hrs postoperatively there was no significant difference between ibuprofen and paracetamol combination and diclofenac sodium and paracetamol combination but diclofenac sodium and paracetamol combination was more effective in relieving the postoperative pain.
|Table 2 : represents mean and standard deviation of VAS before and after administration of experimental and placebo drug|
Click here to view
| Discussion|| |
It is well known that pain perception is highly subjective and influenced by many factors which make the precise definition of different discomfort categories and detailed description of pain difficult.  For this reason, the intensity of discomfort experienced by the patients was measured using the Verbal descriptor scale as well as Visual Analogue scale (ranged from 0 to 10).
Most of the patients experience pain in the first 24 hrs after root canal treatment.  Therefore, 24hrs period for assessment was chosen in this study even though the drugs tested would not be expected to provide ongoing analgesia for this entire period owning to their relative short plasma half-lives.
Whilst a number of postoperative dental pain control studies exist, but there is a lack of prospective studies especially comparing efficacy of different drug combinations on the postoperative endodontic pain. The combination of acetaminophen (paracetamol) and NSAIDs demonstrated superior pain control in comparison with that achieved when either drug was used separately. , By combining two or more drugs, a lower dose of each drug will be used resulting in fewer side effects.
Breivik et al,  using a third molar extraction model provides another well-controlled dental study evaluating the combination of voltarol (diclofenac) with acetaminophen (paracetamol) and added additional support for the combination of two drugs to manage pain of a different model.
The mechanism of action of NSAIDs and acetaminophen (paracetamol) are by no means similar. NSAIDs are most effective by affecting the synthesis of prostaglandins by way of inhibition of the cycloxygenase enzyme. NSAIDs have mainly peripheral nervous system effects.  However acetaminophen (paracetamol) acts by inhibiting prostaglandin synthesis in the CNS  and by interacting with serotonin and nitric acid mechanism.  Studies by Bannwarth et al, and Piletta et al, have demonstrated the ability of the drug to cross the blood brain barrier. This may then allow for the inhibition of central hyperalgesia that is induced by pain-producing neurotransmitters like substance P or excitatory amino acid glutamate.  The two drugs have different mechanism of action perhaps when combined they produce a synergistic response.
Only patients with moderate to severe pain were selected as preoperative pain has been established as major determinant of postoperative pain or flare up , and outcome measures were reported in relation to improvement or deterioration rather than mere prevalence of postoperative pain / flare up along numerical value of a visual analogue pain scale.
This prospective, randomized placebo - controlled study compared the analgesic effect of two different drug combinations with those of a placebo under controlled clinical conditions. Inclusion of placebo group was important to eliminate bias in the results. However, patient cooperation and relying on their answers are other potential problems associated with these types of studies. The inclusion of a placebo group is of significant clinical relevance. Pain intensity decreased significantly in all the three groups following the treatment. After some time and inflammation reduction, the pain intensity would be expected to decrease. Previous endodontic studies have concluded that definitive dental treatment without the administration of medication may enhance pain relief significantly.  Results from present study emphasize this point and suggested that definitive dental treatment should be incorporated as an effective treatment strategy for management and prevention of pain.
Currently NSAIDs are extremely beneficial in managing postoperative pain in dentistry.  The combination of a NSAID and acetaminophen can reduce moderate to severe endodontic pain effectively than single medication. 
However, only the effects of these drugs on pain were evaluated in this study and not the adverse effects; thus it is not possible to assess the risk to benefit ratio by using these drugs in this manner.
In future, more research using the different analgesic combinations would be useful as the administration of definitive dental treatment with appropriate analgesics is a significant area in the management of endodontic pain patient.
| Conclusion|| |
A single oral dose of diclofenac sodium and paracetamol and ibuprofen and paracetamol combination reduced postoperative pain following pulpectomy and root canal preparation in teeth with irreversible pulpitis.
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[Table 1], [Table 2]