Efficacy of Different Drugs to Control Post Root Canal Treatment Pain

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ClinicalTrials.gov Identifier: NCT02417337

Recruitment Status : Completed

First Posted : April 15, 2015

Last Update Posted : April 15, 2015

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Sponsor:

Information provided by (Responsible Party):

Dr. Wail Elzaki, University of Khartoum

Study Description

Brief Summary:

Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics are needed to diminish the pain [1]. Development of pain after completion of root canal treatment may undermine patients' confidence in the procedure and the clinician [2]. Non-steroidal anti-inflammatory drugs are one of the most frequently taken analgesic medications for dental pain. Their popularity attributed to their efficacy in relieving pain and fever and low side effect profile at therapeutic doses [3]. Mono-therapy analgesic has a low effect on dental pain. Improvement was performance by combining analgesics with different mechanisms of action without raising any adverse effects [4], was effective in controlling moderate to severe pain. The combination of a non-steroidal anti-inflammatory drug (NSAID) and paracetamol has shown additive analgesia for treating dental pain in several studies [5,6]. Endodontic treatment with a lower prevalence of postoperative pain is usually the treatment of choice. There have been no controlled dental studies evaluating the additive effects of combining a non-steroidal anti-inflammatory drug with paracetamol. Breivik et al [6] & Menhinick et al [7] found that a combination of acetaminophen and ibuprofen was more effective than ibuprofen alone in managing postoperative pain. Aim of the present study, to evaluate the efficacy of the paracetamol when used alone and in combinations with three groups of drugs to control postoperative endodontic pain.

Condition or disease	Intervention/treatment	Phase
Pain Postoperative Pain Irreversible Pulpitis	Procedure: Root Canal Treatment Drug: Paracetamol Drug: Ibuprofen Drug: Mefenamic acid Drug: Diclofenac	Phase 2

Detailed Description:

Background: Management of pain is challenging part of dental treatment, sometimes pain is a major postoperative symptom after many dental procedures especially for endodontics. The aim of the present randomized clinical trial was to investigate the efficacy of using paracetamol alone and three combinations of non-steroidal anti-inflammatory drugs with paracetamol, to control postoperative endodontics pain.

Methodology: 185 patients who had anterior or premolar teeth with irreversible pulpitis without any signs and symptoms of apical periodontitis and with moderate to severe pain. Patients were divided by allocation randomization into five groups. Four experimental groups receiving different medication; group I (single dose of paracetamol); group II (ibuprofen / paracetamol); group III (diclofenac k / paracetamol), group IV (mefenamic acid /paracetamol) and group V (no medication group). The groups received the medication after the first appointment where the pulp removed, and canals fully prepared. Pain intensity was scored based on 10-point VAS before and after treatment for up to 8 hours postoperatively. Sign test used for comparing pain score before and after treatment. This randomized control clinical trial was conducted on patients who were considered potential candidates if they had moderate to severe spontaneous pain of odontogenic origin (40-100 mm on a visual analogue scale, VAS). Patients were selected from those attending the Conservative dentistry clinics in both the University and the Teaching Hospital Emergency Clinic.

The medications were prepared in the laboratories of faculty of Pharmacy. Four groups of medications were prepared as follows; Group I: paracetamol 1000mg Group II: ibuprofen 600mg + paracetamol 1000mg, Group III: Mefenamic acid 500mg + Paracetamol 1000mg Group IV: Diclofenac K 50mg + paracetamol 1000 mg

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	170 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics
Study Start Date :	August 2012
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	January 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group I paracetamol 1000mg	Procedure: Root Canal Treatment A standardized endodontic procedures performed. Other Name: Endodontic treatment Drug: Paracetamol
Experimental: Group II ibuprofen 600mg + paracetamol 1000mg,	Procedure: Root Canal Treatment A standardized endodontic procedures performed. Other Name: Endodontic treatment Drug: Paracetamol Drug: Ibuprofen
Experimental: Group III Mefenamic acid 500mg + Paracetamol 1000mg	Procedure: Root Canal Treatment A standardized endodontic procedures performed. Other Name: Endodontic treatment Drug: Paracetamol Drug: Mefenamic acid
Experimental: Group IV Diclofenac K 50mg + paracetamol 1000 mg	Procedure: Root Canal Treatment A standardized endodontic procedures performed. Other Name: Endodontic treatment Drug: Paracetamol Drug: Diclofenac
Placebo Comparator: Group V No medication	Procedure: Root Canal Treatment A standardized endodontic procedures performed. Other Name: Endodontic treatment

Outcome Measures

Primary Outcome Measures :

Efficacy of different Drugs to Control Post Root Canal Treatment Pain as measured by Visual Analogue Scale. [ Time Frame: 8 hours ]
The patients were asked to make entries on the VAS (numerical score) every hour for the first 4 hours after taking the medication and then every 2 hours following that; a total of six entries over 8 hours.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patient reported spontaneous pain moderate to severe, ranging from 50 to 100 mm on a VAS (0-100 mm);
Adult patients presented for emergency endodontic treatment with a symptomatic maxillary or mandibular tooth (anterior and premolar) with a pulpal diagnosis of Irreversible pulpitis and normal periapex.
Patient choose to have root canal treatment for pain of endodontic origin.
The patient presented with American Society of Anesthesiologists (ASA) I or II medical history (ASA 1963).
The patient had read and thoroughly understood the pain score level sheet

Exclusion Criteria:

Patients below 18 years of age;
Analgesic taken within the last 4 hours;
History of allergy to NSAIDs, paracetamol or local anaesthetics;
History of uncontrolled systemic disease [gastrointestinal (GI) disorders, oesophageal reflux, active asthma, decreased hepatic function, haemorrhagic disorders, or poorly controlled diabetes mellitus].
Patients currently taking opioids, monoamine oxidase inhibitors, tricyclic antidepresssants, carbamazepine, diuretics, or anticoagulants;
There was history of opioid addiction or abuse; and
Pregnant or nursing female patients.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417337

Locations

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Sudan
University of Khartoum, Faculty of Dentistry,
Khartoum, Sudan, 111-11

Sponsors and Collaborators

University of Khartoum

More Information

Publications of Results:

Owatz CB, Khan AA, Schindler WG, Schwartz SA, Keiser K, Hargreaves KM. The incidence of mechanical allodynia in patients with irreversible pulpitis. J Endod. 2007 May;33(5):552-6. doi: 10.1016/j.joen.2007.01.023. Epub 2007 Mar 6.

Albashaireh ZS, Alnegrish AS. Postobturation pain after single- and multiple-visit endodontic therapy. A prospective study. J Dent. 1998 Mar;26(3):227-32. doi: 10.1016/s0300-5712(97)00006-7.

Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. J Endod. 2008 Jun;34(6):652-5. doi: 10.1016/j.joen.2008.02.017. Epub 2008 Apr 2.

Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.

Breivik EK, Barkvoll P, Skovlund E. Combining diclofenac with acetaminophen or acetaminophen-codeine after oral surgery: a randomized, double-blind single-dose study. Clin Pharmacol Ther. 1999 Dec;66(6):625-35. doi: 10.1053/cp.1999.v66.103629001.

Keiser K, Hargreaves K.Building effective strategies for the management of endodontic pain. Endodontic Topics, Volume 3, Issue 1, pages 93-105, November 2002

Menhinick KA, Gutmann JL, Regan JD, Taylor SE, Buschang PH. The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, double-blind, placebo-controlled study. Int Endod J. 2004 Aug;37(8):531-41. doi: 10.1111/j.1365-2591.2004.00836.x.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Elzaki WM, Abubakr NH, Ziada HM, Ibrahim YE. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain. J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12.

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Responsible Party:	Dr. Wail Elzaki, Lecturer at Faculty of Dentistry, University of Khartoum
ClinicalTrials.gov Identifier:	NCT02417337
Other Study ID Numbers:	University of Khartoum
First Posted:	April 15, 2015 Key Record Dates
Last Update Posted:	April 15, 2015
Last Verified:	April 2015

Additional relevant MeSH terms:

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Pulpitis Dental Pulp Diseases Tooth Diseases Stomatognathic Diseases Acetaminophen Ibuprofen Diclofenac Mefenamic Acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic	Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antipyretics

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