Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04900571 |
| Other study ID # |
Nitrofurantoin Vs CaOH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
May 18, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Altamash Institute of Dental Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
