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

Phase 4

Completed

• Conditions: Irreversible Pulpitis; Pain, Postoperative
• Interventions: Drug: Nitrofurantoin 100 MG

• Registration Number: NCT04900571
• Lead Sponsor: Altamash Institute of Dental Medicine

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 Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-05
• Primary Completion: 2021-05-18
• Study Completion: 2021-05-18
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitrofurantoin	Nitrofurantoin 100 MG	Measuring pain score using numerical pain scale post-operatively at different time intervals.
Calcium Hydroxide	Nitrofurantoin 100 MG	Measuring pain score using numerical pain scale post-operatively at different time intervals.
Control	Nitrofurantoin 100 MG	Measuring pain score using numerical pain scale post-operatively at different time intervals.

Primary Outcome Measures

Name	Time	Method
Group 3: Control	5 months	Measuring incidence of Post-operative Pain using Numerical Pain Scale
Group 1: Nitrofurantoin	5 months	Measuring incidence of Post-operative Pain using Numerical Pain Scale
Group 2: Calcium Hydroxide	5 months	Measuring incidence of Post-operative Pain using Numerical Pain Scale

Trial Locations

Locations (1)

Altamash Institute of Dental Medicine; 🇵🇰 Karachi, Sindh, Pakistan