Clinical trial NCT06971055: Moringa Oleifera vs Sodium Hypochlorite for Root Canal Irrigation in Nonvital Primary Molars
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Pulp Necrosis
Primary Tooth Pulpectomy
Pediatric Dentistry
Endodontic Infection
Keywords: Moringa oleifera
Sodium hypochlorite
Root canal irrigants
Pulpectomy
Primary molars
Enterococcus faecalis
Antimicrobial efficacy
Pediatric endodontics
Coagulase-Negative Staphylococci
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Zone of inhibition against Coagulase-Negative Staphylococci
timeFrame: "Day 1 (Pre- and post-irrigation samples collected during the same visit)"
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University
Study officials:
References: