Back to resultsThe Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste
Primary Purpose
Pain, Symptomatic Irreversible Pulpitis
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Nitrofurantoin
Double Antibiotic
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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
Sites / Locations
- Hira Danish
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Nitrofurantoin
Double antibiotic paste
Control
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05600023
First Posted
October 25, 2022
Last Updated
October 27, 2022
Sponsor
Altamash Institute of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05600023
Brief Title
The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
October 24, 2022 (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
5. 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.
Detailed Description
This study aims to compare the efficacy in alleviating pain between intracanal medicaments Nitrofurantoin versus double antibiotic paste.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Symptomatic 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 Title
Double antibiotic paste
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin
Intervention Description
Nitrofurantoin has been found to successfully eradicate gram-negative bacteria such as Enterococcus faecalis that one of the most important bacteria in endodontic lesions
Intervention Type
Drug
Intervention Name(s)
Double Antibiotic
Intervention Description
DAP is a combination of two antibiotics which are ciprofloxacin and metronidazole
Primary Outcome Measure Information:
Title
To alleviate dental pain
Description
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
Time Frame
12 hours upto 72 hours following placement of intracanal medicament
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hira Danish
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste
We'll reach out to this number within 24 hrs