Comparison of Nitrofurantoin and Calcium Hydroxide as Intracanal Medicaments in Alleviating Post-operative Pain

May 21, 2021 updated by: Hira Abbasi, Altamash Institute of Dental Medicine

Comparison of Single Antibiotic Paste Nitrofurantoin and Calcium Hydroxide Paste as Intracanal Medicaments in Alleviating Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis -A Randomized Controlled Trial

Intracanal medicaments have been frequently used in patients with endodontic and periradicular infection for the elimination of microorganisms. Commonly used includes Double Antibiotic Paste, Triple Antibiotic Paste, and Calcium Hydroxide. This study aims to compare the efficacy in alleviating pain between intracanal medicaments Nitrofurantoin and Calcium Hydroxide Paste. 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. Pre-operative pain score was initially recorded, followed by Post-operative pain at 12, 24, 48, and 72 hours. Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intracanal medicaments have been frequently used in patients with endodontic and periradicular infection for the elimination of microorganisms. Commonly used includes Double Antibiotic Paste, Triple Antibiotic Paste, and Calcium Hydroxide. This study aims to compare the efficacy in alleviating pain between intracanal medicaments Nitrofurantoin and Calcium Hydroxide Paste.

60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by Post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single root teeth with patients suffering from symptomatic irreversible pulpitis.

Total of 20 patients were randomized into 3 groups. Majority of the patients in all 3 groups initially presented with moderate to severe pre-operative pain. After 72 Hours post-operatively, 50% patients in group 1 reported no pain, while 5% patients in both group 2 and 3 had no pain. Pain significantly subsided in group 1 as compared to group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups.

Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • Altamash institute of dental medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No medical history
  • no age restrictions
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nitrofurantoin
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Drug: Nitrofurantoin 100 MG
Comparison of alleviating post-operative pain between nitrofurantoin and calcium hydroxide
Other Names:
  • Calcium Hydroxide
Experimental: Calcium Hydroxide
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Drug: Nitrofurantoin 100 MG
Comparison of alleviating post-operative pain between nitrofurantoin and calcium hydroxide
Other Names:
  • Calcium Hydroxide
Experimental: Control
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Drug: Nitrofurantoin 100 MG
Comparison of alleviating post-operative pain between nitrofurantoin and calcium hydroxide
Other Names:
  • Calcium Hydroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Group 1: Nitrofurantoin
Time Frame: 5 months
Measuring incidence of Post-operative Pain using Numerical Pain Scale
5 months
Group 2: Calcium Hydroxide
Time Frame: 5 months
Measuring incidence of Post-operative Pain using Numerical Pain Scale
5 months
Group 3: Control
Time Frame: 5 months
Measuring incidence of Post-operative Pain using Numerical Pain Scale
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altamash Institute of Dental Medicine

Investigators

  • Principal Investigator: Hira Abbasi, BDS, FCPS II Trainee, Altamash Institute of Dental Medicine, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

May 18, 2021

Study Completion (Actual)

May 18, 2021

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nitrofurantoin Vs CaOH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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