NCT07743372

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Aug 2026

Status
not yet recruiting

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

Study Progress1%
Aug 2026Feb 2028

First Submitted

Initial submission to the registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Outcome Measures

Primary Outcomes (1)

  • Anesthetic success of articaine buccal infiltration

    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)

100mg Diclofenac potassium

EXPERIMENTAL

Preoperative single dose of diclofenac potassium 100mg

Drug: Diclofenac potassium 100mg

50mg Diclofenac potassium

ACTIVE COMPARATOR

Preoperative single dose of diclofenac potassium 50mg

Drug: Diclofenac potassium 50mg

Placebo

PLACEBO COMPARATOR

Preoperative placebo

Drug: Placebo

Interventions

Diclofenac potassium 100mgDRUG

Preoperative single dose of diclofenac potassium 100mg

100mg Diclofenac potassium
Diclofenac potassium 50mgDRUG

Preoperative single dose of diclofenac potassium 50mg

50mg Diclofenac potassium
PlaceboDRUG

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

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 I or II).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 26151766BACKGROUND

  • 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

Ameena K Bagunaid

CONTACT

00201017200542ameena.omar@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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 3, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

August 3, 2026

Record last verified: 2026-02