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

NCT ID: NCT06971055

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-20
• Study Completion Date: 2026-01-01

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

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

Conditions

Dental Caries; Pulp Necrosis; Primary Tooth Pulpectomy; Pediatric Dentistry; Endodontic Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sodium hypochlorite

Intervention Type: DRUG

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

Moringa oleifera Leaf Extract Group

extract of Moringa oleifera leaves prepared as a solution, used as a natural antimicrobial root canal irrigant.

Group Type: EXPERIMENTAL

Moringa Oleifera Leaf Extract

Intervention Type: BIOLOGICAL

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.

Interventions

Sodium hypochlorite

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

Intervention Type: DRUG

Moringa Oleifera Leaf Extract

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alawi Taha A Alaidarous

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Countries

Egypt

Central Contacts

Alawi Taha Alaidarous T Principal Investigator, BDS

Role: CONTACT

al-alawi.ta@hotmail.com

+966500969988

Other Identifiers

Moringa vs Sodium Hypochlorite

Identifier Type: -

Identifier Source: org_study_id