Moringa Oleifera vs Sodium Hypochlorite for Root Canal Irrigation in Nonvital Primary Molars (MORvNAOCL)

May 29, 2025 updated by: Alawi Taha A Alaidarous, Cairo University

Evaluation of Antimicrobial Efficacy of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite as Root Canal Irrigants in Pulpectomy of Nonvital Primary Molars: A Randomized Clinical Trial

This randomized clinical trial aims to evaluate and compare the antimicrobial efficacy of Moringa Oleifera leaf extract versus sodium hypochlorite as root canal irrigants in pulpectomy of nonvital primary molars in pediatric patients. The study will assess bacterial reduction using blood agar

Study Overview

Detailed Description

This randomized clinical trial is designed to compare the antimicrobial efficacy of Moringa Oleifera leaf extract and sodium hypochlorite when used as root canal irrigants in the pulpectomy of nonvital primary molars in children aged 4 to 7 years. Root canal disinfection in pediatric endodontics is essential due to the complex anatomy of primary teeth and the potential systemic implications of untreated infections.

Sodium hypochlorite (NaOCl) is widely used due to its strong antimicrobial and tissue-dissolving properties but is associated with cytotoxic effects and safety concerns in children. Moringa Oleifera, a plant rich in bioactive compounds such as flavonoids and isothiocyanates, has demonstrated antimicrobial, anti-inflammatory, and antioxidant properties, offering a potentially safer and natural alternative.

A total of 38 participants will be randomly assigned to two equal groups. Group 1 will receive root canal irrigation with 2.5% NaOCl, while Group 2 will be irrigated using an ethanol extract of Moringa Oleifera leaves. The primary outcome will be the diameter of the inhibition zone against Coagulase-Negative Staphylococci measured using a blood agar. The secondary outcome will be the diameter of the inhibition zone against Enterococcus Faecalis measured using a blood agar

The study will be conducted at the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department at the Faculty of Dentistry, Cairo University. All procedures will be performed by a single operator (the principal investigator) using a standardized protocol. Data collection will be blinded at the laboratory and statistical analysis levels to minimize bias.

The results of this study aim to determine whether Moringa Oleifera extract can be a safe, effective, and biocompatible alternative to sodium hypochlorite in pediatric root canal irrigation, ultimately enhancing clinical outcomes and patient experience

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alawi Taha Alaidarous T Principal Investigator, BDS
  • Phone Number: +966500969988
  • Email: al-alawi.ta@hotmail.com

Study Locations

      • Cairo, Egypt
        • Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children aged 4 to 7 years
  • Clinically and radiographically diagnosed with nonvital primary molars requiring pulpectomy
  • Cooperative children who can undergo dental treatment
  • Healthy-appearing children with no systemic, physical, or mental disorders

Exclusion Criteria:

  • Medically compromised or uncooperative children
  • Primary molars indicated for extraction due to:
  • Advanced root resorption (more than two-thirds)
  • Teeth near exfoliation
  • Deep subgingival caries preventing proper restoration
  • Excessive mobility (Miller's Grade 2 or higher)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium Hypochlorite Group
Participants in this group will receive root canal irrigation using sodium hypochlorite during pulpectomy of nonvital primary molars. A 3 mL solution will be used per canal following standard clinical procedures.
sodium hypochlorite solution will be used as a root canal irrigant during pulpectomy in primary molars. A volume of 3 mL will be delivered into each canal using a syringe with a side-vented needle. Irrigation will be followed by microbial sampling for blood agar
Experimental: Moringa oleifera Leaf Extract Group
extract of Moringa oleifera leaves prepared as a solution, used as a natural antimicrobial root canal irrigant.
extract of Moringa oleifera leaves will be used as an intracanal irrigant during pulpectomy. A volume of 3 mL will be used per canal, and post-irrigation microbial samples will be analyzed using the same methods as the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zone of inhibition against Coagulase-Negative Staphylococci
Time Frame: "Day 1 (Pre- and post-irrigation samples collected during the same visit)"
"Primary Outcome: The antimicrobial efficacy of both types of irrigants... based on the diameter of the zone of inhibition
"Day 1 (Pre- and post-irrigation samples collected during the same visit)"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2025

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 10, 2025

First Posted (Actual)

May 14, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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