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

Not Applicable

Not yet recruiting

• Conditions: Dental Caries; Pulp Necrosis; Pediatric Dentistry; Primary Tooth Pulpectomy; Endodontic Infection
• Interventions: Drug: Sodium hypochlorite; Biological: Moringa Oleifera Leaf Extract

• Registration Number: NCT06971055
• Lead Sponsor: Cairo University

Brief Summary

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 and ATP bioluminescence analysis.

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 Enterococcus faecalis measured using an blood agar. The secondary outcome will be the reduction of viable microbial load measured via ATP bioluminescence assay

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-10
• Last Update Submitted: 2025-05-10
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Study Start: 2025-07-20
• Primary Completion: 2025-09-15
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Hypochlorite Group	Sodium hypochlorite	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.
Moringa oleifera Leaf Extract Group	Moringa Oleifera Leaf Extract	extract of Moringa oleifera leaves prepared as a solution, used as a natural antimicrobial root canal irrigant.

Primary Outcome Measures

Name	Time	Method
Zone of inhibition against Enterococcus faecalis	"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

Trial Locations

Locations (1)

Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt