NCT04900571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

May 18, 2021

Last Update Submit

May 21, 2021

Conditions

Pain, PostoperativeIrreversible Pulpitis

Keywords

NitrofurantoinCalcium hydroxideIntracanal medicamentsIrreversible pulpitis

Outcome Measures

Primary Outcomes (3)

  • Group 1: Nitrofurantoin

    Measuring incidence of Post-operative Pain using Numerical Pain Scale

    5 months

  • Group 2: Calcium Hydroxide

    Measuring incidence of Post-operative Pain using Numerical Pain Scale

    5 months

  • Group 3: Control

    Measuring incidence of Post-operative Pain using Numerical Pain Scale

    5 months

Study Arms (3)

Nitrofurantoin

EXPERIMENTAL

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

Drug: Nitrofurantoin 100 MG

Calcium Hydroxide

EXPERIMENTAL

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

Drug: Nitrofurantoin 100 MG

Control

EXPERIMENTAL

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

Drug: Nitrofurantoin 100 MG

Interventions

Nitrofurantoin 100 MGDRUG

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

Also known as: Calcium Hydroxide
Calcium HydroxideControlNitrofurantoin

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • No medical history
  • no age restrictions
  • no history of allergy to medications used in root canal treatment
  • patients suffering from Symptomatic Irreversible Pulpitis

You may not qualify if:

  • Patients who were not suitable for conventional root canal treatment
  • multirooted teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altamash Institute of Dental Medicine

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

NitrofurantoinCalcium Hydroxide

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Officials

  • Hira Abbasi, BDS, FCPS II Trainee

    Altamash Institute of Dental Medicine, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 25, 2021

Study Start

January 1, 2021

Primary Completion

May 18, 2021

Study Completion

May 18, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

PA(1)