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

Sponsor
Altamash Institute of Dental Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04900571
Collaborator
(none)
60
1
3
4.5
13.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nitrofurantoin 100 MG
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
May 18, 2021
Actual Study Completion Date :
May 18, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Group 1: Nitrofurantoin [5 months]

      Measuring incidence of Post-operative Pain using Numerical Pain Scale

    2. Group 2: Calcium Hydroxide [5 months]

      Measuring incidence of Post-operative Pain using Numerical Pain Scale

    3. Group 3: Control [5 months]

      Measuring incidence of Post-operative Pain using Numerical Pain Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Altamash Institute of Dental Medicine Karachi Sindh Pakistan 75500

    Sponsors and Collaborators

    • Altamash Institute of Dental Medicine

    Investigators

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

    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:
    NCT04900571
    Other Study ID Numbers:
    • Nitrofurantoin Vs CaOH
    First Posted:
    May 25, 2021
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hira Abbasi, Principal Investigator, Altamash Institute of Dental Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 25, 2021