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

NCT ID: NCT04900571

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-05-18

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nitrofurantoin

Measuring pain score using numerical pain scale post-operatively at different time intervals.

Group Type EXPERIMENTAL

Nitrofurantoin 100 MG

Intervention Type DRUG

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

Calcium Hydroxide

Measuring pain score using numerical pain scale post-operatively at different time intervals.

Group Type EXPERIMENTAL

Nitrofurantoin 100 MG

Intervention Type DRUG

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

Control

Measuring pain score using numerical pain scale post-operatively at different time intervals.

Group Type EXPERIMENTAL

Nitrofurantoin 100 MG

Intervention Type DRUG

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

Interventions

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Nitrofurantoin 100 MG

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

Intervention Type DRUG

Other Intervention Names

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Calcium Hydroxide

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Altamash Institute of Dental Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hira Abbasi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hira Abbasi, BDS, FCPS II Trainee

Role: PRINCIPAL_INVESTIGATOR

Altamash Institute of Dental Medicine, Pakistan

Locations

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Altamash Institute of Dental Medicine

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Nitrofurantoin Vs CaOH

Identifier Type: -

Identifier Source: org_study_id

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