NCT07271654

Brief Summary

This randomized controlled trial investigated whether a single dose of diclofenac sodium taken before a root canal procedure can reduce pain in the hours following the treatment. 160 patients with tooth pain from irreversible pulpitis were divided into two groups. One group received 100mg of diclofenac sodium 30 minutes before their procedure, while the other group received no pretreatment. Pain levels were measured at 6, 12, and 24 hours after the procedure. The study found that patients who took diclofenac before treatment were significantly more likely to be pain-free at 6 and 12 hours after the procedure compared to those who did not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 26, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

Endodontic painNSAIDSpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postendodontic Pain

    Proportion of patients reporting no pain, mild pain, moderate pain, or severe pain as measured on a Visual Analogue Scale (VAS

    6 hours after endodontic treatment

Secondary Outcomes (2)

  • Incidence of Postendodontic Pain

    12 hours after endodontic treatment

  • Incidence of Postendodontic Pain

    24 hours after endodontic treatment

Study Arms (2)

pre treatment with NSAIDS

EXPERIMENTAL

Experimental

Procedure: Pre treatment with NSAIDSProcedure: No pretreatment with NSAIDS.

No pre treatment with NSAIDS

ACTIVE COMPARATOR

No pretreatment medication was administered before endodontic treatment.

Procedure: Pre treatment with NSAIDSProcedure: No pretreatment with NSAIDS.

Interventions

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

No pre treatment with NSAIDSpre treatment with NSAIDS

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

No pre treatment with NSAIDSpre treatment with NSAIDS

Eligibility Criteria

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

You may not qualify if:

  • Current use of prophylactic antibiotics.
  • Pregnancy or lactation.
  • Mental disabilities.
  • Systemic illnesses contraindicating endodontic therapy.
  • Known hypersensitivity or adverse reaction to NSAIDs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saidu College of dentistry,Swat

Swat, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Resident, Department of Operative Dentistry

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

August 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations