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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
Information provided by (Responsible Party):
Dr. Wail Elzaki, University of Khartoum

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

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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

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

Primary Outcome Measures :
  1. 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.

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

Inclusion Criteria:

  1. Patient reported spontaneous pain moderate to severe, ranging from 50 to 100 mm on a VAS (0-100 mm);
  2. 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.
  3. Patient choose to have root canal treatment for pain of endodontic origin.
  4. The patient presented with American Society of Anesthesiologists (ASA) I or II medical history (ASA 1963).
  5. The patient had read and thoroughly understood the pain score level sheet

Exclusion Criteria:

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

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

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University of Khartoum, Faculty of Dentistry,
Khartoum, Sudan, 111-11
Sponsors and Collaborators
University of Khartoum
Publications of Results:
Keiser K, Hargreaves K.Building effective strategies for the management of endodontic pain. Endodontic Topics, Volume 3, Issue 1, pages 93-105, November 2002

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Mefenamic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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