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

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04900571
Enrollment
60
Registered
2021-05-25
Start date
2021-01-01
Completion date
2021-05-18
Last updated
2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Irreversible Pulpitis

Keywords

Nitrofurantoin, Calcium hydroxide, Intracanal medicaments, Irreversible pulpitis

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.

Interventions

Comparison of alleviating post-operative pain between nitrofurantoin and calcium hydroxide

Sponsors

Altamash Institute of Dental Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Group 1: Nitrofurantoin5 monthsMeasuring incidence of Post-operative Pain using Numerical Pain Scale
Group 2: Calcium Hydroxide5 monthsMeasuring incidence of Post-operative Pain using Numerical Pain Scale
Group 3: Control5 monthsMeasuring incidence of Post-operative Pain using Numerical Pain Scale

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026