NCT04947566

Brief Summary

Comparison between Naproxen and Ibuprofen in management of post operative endodontic pain was done.Total 116 patients were selected and divided in to two groups.One group was given Naproxen and other was given Ibuprofen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

June 24, 2021

Last Update Submit

July 1, 2021

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • post-operative pain

    Post-operative pain was measured subjectively after 24 hours with standard Visual Analogue Score (VAS) scored on a 10 cm scale, with markings at every 1 cm anchored by the end points of "no pain" on the left and "worst pain" on the right. Patient were asked to point the number most precisely describing the amount of pain he or she experienced after 24 hours.

    6 months

Study Arms (2)

Naproxen

EXPERIMENTAL

in this group patients were given Naproxen

Drug: Comparison of Efficacy of Naproxen versus Ibuprofen

Ibuprofen

EXPERIMENTAL

in this group patients were given ibuprofen

Drug: Comparison of Efficacy of Naproxen versus Ibuprofen

Interventions

Comparison of Efficacy of Naproxen versus IbuprofenDRUG

Comparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth with Irreversible Pulpitis

IbuprofenNaproxen

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 20-40 years
  • Gender- either
  • Teeth with acute Irreversible pulpitis assessed by Electric pulp tester lasting more than 30 seconds
  • One tooth per arch with no opposing tooth involved

You may not qualify if:

  • Patients who reported to have any systemic disease while taking history e.g. diabetes, hypertension
  • During pregnancy
  • History of taking analgesics 12 hours prior to treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FatimaMH

Lahore, Punjab Province, 53000, Pakistan

Location

FatinaMH

Lahore, Punjab Province, 53000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Zarlashta Usman, BDS

    Fatima Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ZUsman

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 1, 2021

Study Start

September 2, 2019

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

July 6, 2021

Record last verified: 2021-07

Locations

PA(2)