Viewing Study NCT04900571



Ignite Creation Date: 2024-05-06 @ 4:12 PM
Last Modification Date: 2024-10-26 @ 2:05 PM
Study NCT ID: NCT04900571
Status: COMPLETED
Last Update Posted: 2021-05-25
First Post: 2021-05-18

Brief Title: Comparison of Nitrofurantoin and Calcium Hydroxide as Intracanal Medicaments in Alleviating Post-operative Pain
Sponsor: Altamash Institute of Dental Medicine
Organization: Altamash Institute of Dental Medicine

Study Overview

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
Status: COMPLETED
Status Verified Date: 2021-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None