NCT06980870

Brief Summary

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain with symptomatic irreversible pulpitis

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

February 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

May 20, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 15, 2025

Last Update Submit

May 17, 2025

Conditions

Keywords

post-endodontic painibuprofendexamethasone

Outcome Measures

Primary Outcomes (3)

  • effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain

    Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale

    24 hours

  • effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain

    Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale

    48 hours

  • effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain

    Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale

    72 hours

Study Arms (2)

Pain with ibuprofen

ACTIVE COMPARATOR

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Drug: Anti-inflammatory drug (ibuprofen)

Pain with dexamethasone

ACTIVE COMPARATOR

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Drug: Anti-inflammatory drug (dexamethsaone)

Interventions

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Pain with ibuprofen

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Pain with dexamethasone

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
  • Patients of either gender aged between 18-50 years old.
  • Systemically healthy patients.
  • Patients who agree to attend for recall appointments and provide a written consent.

You may not qualify if:

  • Patients on preoperative analgesics and antibiotics.
  • Teeth with calcified canals and previously treated teeth.
  • Pregnant and lactating mothers.
  • Patients who are immunocompromised, anxious and mentally handicapped.
  • Patients who are allergic to any of the test medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute Of Dentistry

Rawalpindi, 46000, Pakistan

RECRUITING

MeSH Terms

Interventions

Anti-Inflammatory AgentsIbuprofen

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and UsesPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Quratulain Abbasi, BDS

    AFID

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Quratulain Abbasi, BDS

CONTACT

Maha Ali Mirza, BDS

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Graduate Resident Operative Dentistry & Endodontic

Study Record Dates

First Submitted

February 15, 2025

First Posted

May 20, 2025

Study Start

February 15, 2025

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

May 20, 2025

Record last verified: 2025-02

Locations