CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 185 enrolled
Drug / intervention
Paracetamol +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02417337
NCT02417337Phase 2Completed

Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics

University of Khartoum·interventional·Posted Apr 15, 2015·Updated Jun 25, 2026

In Brief

A Phase 2 clinical trial evaluating Paracetamol, Ibuprofen, and 3 other interventions for Pain and 2 related conditions. Completed, enrolled 185 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSudan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2015
Enrollment StartAug 1, 2012
Primary CompletionAug 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.2 years ago

Interventions

Paracetamoldrug

NSAID

Ibuprofendrug

NSAID

Mefenamic Aciddrug

NSAID

Diclofenacdrug

NSAID

Placeboother

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