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Not yet recruiting NCT06971055

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

No phase Interventional Dental Caries Pulp Necrosis Primary Tooth Pulpectomy Pediatric Dentistry

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sodium hypochlorite, Moringa Oleifera Leaf Extract.
Who it may be relevant to
Registry conditions: Dental Caries, Pulp Necrosis, Primary Tooth Pulpectomy, Pediatric Dentistry. Basic parameters: 4 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

Interventions

  • Drug 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
  • Biological 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.

Primary outcome measures

  • Zone of inhibition against Coagulase-Negative Staphylococci [Time frame: "Day 1 (Pre- and post-irrigation samples collected during the same visit)"]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo Unive — Cairo

Identifiers

NCT: NCT06971055 · Moringa vs Sodium Hypochlorite

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗