Efficacy of Different Drugs to Control Post Root Canal Treatment Pain

NCT02417337 | Completed Phase 2 Results

• 1 other identifier: University of Khartoum
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics are needed to diminish the pain \[Owatz et al 2007\]. Development of pain after completion of root canal treatment may undermine patients' confidence in the procedure and the clinician \[Albashaireh and Alnegrish 1998\]. 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 \[Attar et al 2008\]. 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 \[Mehlisch 2002\], 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 \[Breivik et al1999, Keiser and Hargreaves 2002\]. 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 al1999 \& Menhinick et al 2004 found that a combination of acetaminophen and ibuprofen was more effective than ibuprofen alone in managing postoperative pain \[Breivik et al1999 \& Menhinick et al 2004\]. 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.

Conditions

Pain; Postoperative Pain; Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Pain Score on Numerical Rating Scale of Pain (NRS-11)

  (NRS-11) numerical rating scale of pain between 0 (better) and 10 (worse) before and after treatment

  8 hours

Secondary Outcomes (1)

• Mean of Pain Reduction Stratified by Sex and Jaw Type on Numerical Rating Scale (NRS-11)

  8 hours

Study Arms (5)

Group I

ACTIVE COMPARATOR

paracetamol 1000mg

Drug: Paracetamol

Group II

EXPERIMENTAL

ibuprofen 600mg + paracetamol 1000mg,

Drug: Paracetamol; Drug: Ibuprofen

Group III

EXPERIMENTAL

Mefenamic acid 500mg + Paracetamol 1000mg

Drug: Paracetamol; Drug: Mefenamic Acid

Group IV

EXPERIMENTAL

Diclofenac K 50mg + paracetamol 1000 mg

Drug: Paracetamol; Drug: Diclofenac

Group V

OTHER

Placebo, no medication

Other: Placebo

Interventions

Paracetamol DRUG

NSAID

Also known as: Acetaminophen

Group I; Group II; Group III; Group IV

Ibuprofen DRUG

NSAID

Also known as: isobutylphenyl propanoic acid

Group II

Mefenamic Acid DRUG

NSAID

Also known as: Fenamate

Group III

Diclofenac DRUG

NSAID

Also known as: Voltaren

Group IV

Placebo OTHER

empty double gelatinous capsules, having similar weight and appearance of the medications

Also known as: no medication

Group V

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Spontaneous pain moderate to severe on the verbal rating scale (VRS-4), ranging from 4-10 score based on the numerical rating scale (NRS-11).
• 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

You may not qualify if:

• 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 antidepressants, carbamazepine, diuretics, or anticoagulants;
• There was history of opioid addiction or abuse; and
• Pregnant or nursing female patients.

Sponsors & Collaborators

• University of Khartoum: lead

Study Sites (1)

University of Khartoum, Faculty of Dentistry,

Khartoum, 111-11, Sudan

Location

Related Publications (8)

• 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.

  PMID: 17437870 RESULT

• 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.

  PMID: 9594474 RESULT

• 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.

  PMID: 18498882 RESULT

• 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.

  PMID: 12148679 RESULT

• 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.

  PMID: 10613619 RESULT

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

  RESULT

• 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.

  PMID: 15230906 RESULT

• 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.

  PMID: 27080115 DERIVED

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Acetaminophen; Ibuprofen; Mefenamic Acid; Diclofenac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylacetates

Limitations and Caveats

One limitation was the time frame for the analysis of pain; more information would have been available if there were a 24-hour outcome line

Results Point of Contact

• Title: Neamat Abubakr
• Organization: University of Khartoum

neamat@yahoo.com

009661182

Study Officials

• Neamat Abubakr, BDS,MDSc,PhD

  Faculty of Dentistry, University of Khartoum

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Faculty of Dentistry

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 15, 2015
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 25, 2026
• Results First Posted: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SU (1)