Efficacy of Different Drugs to Control Post Root Canal Treatment Pain

NCT02417337 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2026-08-10

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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

Interventions

DRUG

Paracetamol

NSAID

DRUG

Ibuprofen

NSAID

DRUG

Mefenamic Acid

NSAID

DRUG

Diclofenac

NSAID

OTHER

Placebo

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

Sponsors & Collaborators

  • University of Khartoum

    lead OTHER

Principal Investigators

  • Neamat Abubakr, BDS,MDSc,PhD · Faculty of Dentistry, University of Khartoum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-08-31
Completion
2015-01-31

Countries

  • Sudan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02417337 on ClinicalTrials.gov