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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

Tracking Information
First Submitted Date  ICMJE March 30, 2015
First Posted Date  ICMJE April 15, 2015
Last Update Posted Date April 15, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy of Different Drugs to Control Post Root Canal Treatment Pain
Official Title  ICMJE Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Postoperative Pain
  • Irreversible Pulpitis
Intervention  ICMJE
  • Procedure: Root Canal Treatment
    A standardized endodontic procedures performed.
    Other Name: Endodontic treatment
  • Drug: Paracetamol
  • Drug: Ibuprofen
  • Drug: Mefenamic acid
  • Drug: Diclofenac
Study Arms  ICMJE
  • Active Comparator: Group I
    paracetamol 1000mg
    • Procedure: Root Canal Treatment
    • Drug: Paracetamol
  • Experimental: Group II
    ibuprofen 600mg + paracetamol 1000mg,
    • Procedure: Root Canal Treatment
    • Drug: Paracetamol
    • Drug: Ibuprofen
  • Experimental: Group III
    Mefenamic acid 500mg + Paracetamol 1000mg
    • Procedure: Root Canal Treatment
    • Drug: Paracetamol
    • Drug: Mefenamic acid
  • Experimental: Group IV
    Diclofenac K 50mg + paracetamol 1000 mg
    • Procedure: Root Canal Treatment
    • Drug: Paracetamol
    • Drug: Diclofenac
  • Placebo Comparator: Group V
    No medication
    Intervention: Procedure: Root Canal Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2015)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sudan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02417337
Other Study ID Numbers  ICMJE University of Khartoum
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Wail Elzaki, University of Khartoum
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Khartoum
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Khartoum
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP