Comparison of Nitrofurantoin and Calcium Hydroxide as Intracanal Medicaments in Alleviating Post-operative Pain
Primary Purpose
Pain, Postoperative, Irreversible Pulpitis
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Nitrofurantoin 100 MG
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Nitrofurantoin, Calcium hydroxide, Intracanal medicaments, Irreversible pulpitis
Eligibility Criteria
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
Sites / Locations
- Altamash Institute of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Nitrofurantoin
Calcium Hydroxide
Control
Arm Description
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Outcomes
Primary Outcome Measures
Group 1: Nitrofurantoin
Measuring incidence of Post-operative Pain using Numerical Pain Scale
Group 2: Calcium Hydroxide
Measuring incidence of Post-operative Pain using Numerical Pain Scale
Group 3: Control
Measuring incidence of Post-operative Pain using Numerical Pain Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT04900571
First Posted
May 18, 2021
Last Updated
May 21, 2021
Sponsor
Altamash Institute of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04900571
Brief Title
Comparison of Nitrofurantoin and Calcium Hydroxide as Intracanal Medicaments in Alleviating Post-operative Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altamash Institute of Dental Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Irreversible Pulpitis
Keywords
Nitrofurantoin, Calcium hydroxide, Intracanal medicaments, Irreversible pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitrofurantoin
Arm Type
Experimental
Arm Description
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Arm Title
Calcium Hydroxide
Arm Type
Experimental
Arm Description
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Arm Title
Control
Arm Type
Experimental
Arm Description
Measuring pain score using numerical pain scale post-operatively at different time intervals.
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin 100 MG
Other Intervention Name(s)
Calcium Hydroxide
Intervention Description
Comparison of alleviating post-operative pain between nitrofurantoin and calcium hydroxide
Primary Outcome Measure Information:
Title
Group 1: Nitrofurantoin
Description
Measuring incidence of Post-operative Pain using Numerical Pain Scale
Time Frame
5 months
Title
Group 2: Calcium Hydroxide
Description
Measuring incidence of Post-operative Pain using Numerical Pain Scale
Time Frame
5 months
Title
Group 3: Control
Description
Measuring incidence of Post-operative Pain using Numerical Pain Scale
Time Frame
5 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira Abbasi, BDS, FCPS II Trainee
Organizational Affiliation
Altamash Institute of Dental Medicine, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altamash Institute of Dental Medicine
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparison of Nitrofurantoin and Calcium Hydroxide as Intracanal Medicaments in Alleviating Post-operative Pain
We'll reach out to this number within 24 hrs