The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Drug: Nitrofurantoin; Drug: Double Antibiotic

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Hira Danish

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Altamash Institute of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 24, 2022
• Study Completion (Actual): October 24, 2022

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Anti-Infective Agents; Anti-Infective Agents, Urinary; Renal Agents; Anti-Bacterial Agents; Nitrofurantoin
• Other Study ID Numbers: Intracanal medication

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No