NCT04593160

Brief Summary

The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 2, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

September 23, 2026

Status Verified

August 1, 2026

Enrollment Period

2.6 years

First QC Date

October 13, 2020

Last Update Submit

September 20, 2026

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

  • Anesthetic success of inferior alveolar nerve block

    Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.

    During the treatment

Secondary Outcomes (6)

  • Postoperative pain at 6 hours

    6 hours

  • Postoperative pain at 12 hours

    12 hours

  • Postoperative pain at 24 hours

    24 hours

  • Postoperative pain at 48 hours

    48 hours

  • Postoperative pain at 72 hours

    72 hours

  • +1 more secondary outcomes

Study Arms (3)

Diclofenac potassium- acetaminophen combination

EXPERIMENTAL

Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination

Drug: Diclofenac potassium- acetaminophen combination

Diclofenac potassium

EXPERIMENTAL

Preoperative single dose of diclofenac potassium(50mg)

Drug: Diclofenac potassium

Placebo

PLACEBO COMPARATOR

Preoperative single dose of placebo

Drug: Placebo

Interventions

Diclofenac potassium- acetaminophen combinationDRUG

Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination

Diclofenac potassium- acetaminophen combination
Diclofenac potassiumDRUG

Preoperative single dose of diclofenac potassium(50mg)

Diclofenac potassium
PlaceboDRUG

Preoperative single dose of placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic irreversible pulpitis with/without mechanical allodynia
  • Patients with moderato to severe spontaneous pain
  • Mandibular molars
  • Patients with the ability to understand and use the pain scale
  • Patients accepting enrollment in the study

You may not qualify if:

  • 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 \> II)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Related Publications (3)

  • Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.

    PMID: 29709297BACKGROUND

  • Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.

    PMID: 17185119BACKGROUND

  • 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: 32470370BACKGROUND

MeSH Terms

Interventions

Diclofenac

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
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
Postgraduate student

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 19, 2020

Study Start

March 2, 2022

Primary Completion

October 20, 2024

Study Completion

October 10, 2025

Last Updated

September 23, 2026

Record last verified: 2026-08

Locations

EG(1)