NCT05600023

Brief Summary

In our study, we used nitrofurantoin as a root canal medication in patients suffering from symptomatic irreversible pulpitis in alleviating pain compared with double antibiotic paste.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_4 pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

October 25, 2022

Last Update Submit

October 27, 2022

Conditions

PainSymptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

  • To alleviate dental pain

    Dental pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured

    12 hours upto 72 hours following placement of intracanal medicament

Study Arms (3)

Nitrofurantoin

EXPERIMENTAL
Drug: Nitrofurantoin

Double antibiotic paste

EXPERIMENTAL
Drug: Double Antibiotic

Control

NO INTERVENTION

Interventions

NitrofurantoinDRUG

Nitrofurantoin has been found to successfully eradicate gram-negative bacteria such as Enterococcus faecalis that one of the most important bacteria in endodontic lesions

Nitrofurantoin
Double AntibioticDRUG

DAP is a combination of two antibiotics which are ciprofloxacin and metronidazole

Double antibiotic paste

Eligibility Criteria

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

You may qualify if:

  • No medical history
  • no history of allergy to medications used in root canal treatment
  • patients suffering from Symptomatic Irreversible Pulpitis

You may not qualify if:

  • Patients who were not suitable for conventional root canal treatment
  • multirooted teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hira Danish

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsFuransHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 31, 2022

Study Start

August 1, 2022

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)