- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06971055
- Original Trial
Moringa Oleifera vs Sodium Hypochlorite for Root Canal Irrigation in Nonvital Primary Molars (MORvNAOCL)
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Moringa vs Sodium Hypochlorite
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Dental Caries
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
Future University in EgyptNot yet recruitingDeep Caries | Caries, Dental
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Marmara UniversityCompleted
-
Suez Canal UniversityCompleted
-
Pomeranian Medical University SzczecinCompleted
-
Universidad Autonoma de Baja CaliforniaNot yet recruitingDental Caries in Children | Caries, Dental | Caries; DentinMexico
Clinical Trials on Moringa Oleifera Leaf Extract
-
Chulalongkorn UniversityCompletedPostpartum WomenThailand
-
University of KentuckyUniversity of IdahoCompleted
-
Cairo UniversityRecruiting
-
Cairo UniversityNot yet recruitingNonvital Primary MolarsEgypt
-
Universidad de ColimaInstituto Mexicano del Seguro SocialCompletedMetabolic Syndrome | Nutritional and Metabolic DiseasesMexico
-
Deraya UniversityCompleted
-
Melania AsiIndonesia-MoHCompletedPostpartum Depression (PPD)Indonesia
-
Cairo UniversityNot yet recruiting
-
Suzanna L AttiaFogarty International Center of the National Institute of HealthCompletedMalnutrition | Wasting | Growth FailureKenya
-
University of MilanCompletedType 2 DiabetesAlgeria