The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste

Sponsor

Altamash Institute of Dental Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT05600023

Collaborator

(none)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

21.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Symptomatic Irreversible Pulpitis	Drug: Nitrofurantoin Drug: Double Antibiotic	Phase 4

Detailed Description

This study aims to compare the efficacy in alleviating pain between intracanal medicaments Nitrofurantoin versus double antibiotic paste.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Effectiveness of Single Antibiotic Paste Nitrofurantoin V/S Double Antibiotic Paste in Alleviation of Post-Operative Pain in Adult Patients Symptomatic Irreversible Pulpitis

Actual Study Start Date :

Aug 1, 2022

Actual Primary Completion Date :

Oct 24, 2022

Actual Study Completion Date :

Oct 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nitrofurantoin	Drug: Nitrofurantoin Nitrofurantoin has been found to successfully eradicate gram-negative bacteria such as Enterococcus faecalis that one of the most important bacteria in endodontic lesions
Experimental: Double antibiotic paste	Drug: Double Antibiotic DAP is a combination of two antibiotics which are ciprofloxacin and metronidazole
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Nitrofurantoin

Drug: Nitrofurantoin

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

Experimental: Double antibiotic paste

Drug: Double Antibiotic

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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

To alleviate dental pain [12 hours upto 72 hours following placement of intracanal medicament]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hira Danish	Karachi	Sindh	Pakistan	75500

Sponsors and Collaborators

Altamash Institute of Dental Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hira Abbasi, Principal Investigator, Altamash Institute of Dental Medicine

ClinicalTrials.gov Identifier:

NCT05600023

Other Study ID Numbers:

Intracanal medication

First Posted:

Oct 31, 2022

Last Update Posted:

Oct 31, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulpitis

Anti-Bacterial Agents

Nitrofurantoin

Study Results

No Results Posted as of Oct 31, 2022