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Not yet recruiting NCT07743372

Effect of Preoperative Diclofenac Potassium Dose on Endodontic Pain

No phase Interventional Symptomatic Irreversible Pulpitis (SIP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diclofenac potassium 100mg, Diclofenac potassium 50mg, Placebo.
Who it may be relevant to
Registry conditions: Symptomatic Irreversible Pulpitis (SIP). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Diclofenac Potassium Premedication Dose on Anesthetic Success and Post-operative Pain in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Overview

The aim of this study is to assess the effect of different doses of diclofenac potassium premedication (100mg vs 50mg) on anesthetic success of 4% articaine buccal infiltration and post-operative pain as compared to placebo in mandibular molars with symptomatic irreversible pulpitis.

Detailed description

Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (100mg), diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of articaine buccal infiltration will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.

Interventions

  • Drug Diclofenac potassium 100mg
    Preoperative single dose of diclofenac potassium 100mg
  • Drug Diclofenac potassium 50mg
    Preoperative single dose of diclofenac potassium 50mg
  • Drug Placebo
    Preoperative placebo

Primary outcome measures

  • Anesthetic success of articaine buccal infiltration [Time frame: During the treatment]
Secondary outcome measures (6)
  • Postoperative pain at 6 hours [Time frame: 6 hours]
  • Postoperative pain at 12 hours [Time frame: 12 hours]
  • Postoperative pain at 24 hours [Time frame: 24 hours]
  • Postoperative pain at 48 hours [Time frame: 48 hours]
  • Postoperative pain at 72 hours [Time frame: 72 hours]
  • Postoperative pain at 7 days [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • Patients with symptomatic irreversible pulpitis.
  • Patients with moderate to severe pain.
  • Mandibular molars
  • Patients with the ability to understand and use the pain scale

Exclusion criteria

  • Patients allergic to any medication or material to be used in the study.
  • Pregnant and lactating females.
  • Patients taking medications affecting pain perception in the last 12 hours.
  • Patients having more than one symptomatic molar in the same quadrant.
  • Patients with contributory medical history (ASA I or II).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Derry S, Wiffen PJ, Moore RA. Single dose oral diclofenac for acute postoperative pain in adults. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD004768. doi: 10.1002/14651858.CD004768.pub3. PMID 26151766
  • Al-Rawhani AH, Gawdat SI, Wanees Amin SA. Effect of Diclofenac Potassium Premedication on Postendodontic Pain in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Randomized Placebo-Controlled Double-Blind Trial. J Endod. 2020 Aug;46(8):1023-1031. doi: 10.1016/j.joen.2020.05.008. Epub 2020 May 26. PMID 32470370

Identifiers

NCT: NCT07743372 · ENDO-CU-222026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗