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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Status
unknown

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
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

October 13, 2020

Last Update Submit

October 28, 2020

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 - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

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

Central Study Contacts

Sovana T. Abd El-Monem

CONTACT

+201005173697sovana.tarek241@gmail.com

Suzan Amin

CONTACT

suzan.wanis@dentistry.cu.edu.eg

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

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

October 30, 2020

Record last verified: 2020-10