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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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 |
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 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 |
- 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:
- 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.

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
Sudan | |
University of Khartoum, Faculty of Dentistry, | |
Khartoum, Sudan, 111-11 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
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 |