Dental CariesMORvNAOCLNCT06971055
Moringa Oleifera vs Sodium Hypochlorite for Root Canal Irrigation in Nonvital Primary Molars
A study testing Sodium hypochlorite and Moringa Oleifera Leaf Extract in people with Dental Caries and Pulp Necrosis, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Pulp Necrosis, Primary Tooth Pulpectomy
- What is being tested?
- Sodium hypochlorite and Moringa Oleifera Leaf Extract
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University
Cairo
About this study
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
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
Read the 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
- Being tested
- Sodium hypochlorite, Moringa Oleifera Leaf Extract
- Keywords
- Moringa oleifera, Sodium hypochlorite, Root canal irrigants, Pulpectomy, Primary molars, Enterococcus faecalis, Antimicrobial efficacy, Pediatric endodontics, Coagulase-Negative Staphylococci
- Medical subject headings
- Dental Caries, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hypochloriteDrug
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 ExtractBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hypochlorite Group | Experimental | 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. Receives: Drug: Sodium hypochlorite |
| Moringa oleifera Leaf Extract Group | Experimental | extract of Moringa oleifera leaves prepared as a solution, used as a natural antimicrobial root canal irrigant. Receives: Biological: Moringa Oleifera Leaf Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zone of inhibition against Coagulase-Negative Staphylococci
"Primary Outcome: The antimicrobial efficacy of both types of irrigants... based on the diameter of the zone of inhibition
Measured: "Day 1 (Pre- and post-irrigation samples collected during the same visit)"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start20 Jul 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alawi Taha A Alaidarous, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971055
- Sponsor's protocol ID
- Moringa vs Sodium Hypochlorite
- Acronym
- MORvNAOCL
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06971055
- Acronym / sponsor ID
- MORvNAOCL / Moringa vs Sodium Hypochlorite
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Hypochlorite Group | Experimental | Drug: Sodium hypochloriteParticipants 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 | Experimental | Biological: Moringa Oleifera Leaf Extractextract of Moringa oleifera leaves prepared as a solution, used as a natural antimicrobial root canal irrigant. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium hypochloritesodium 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 | Drug | Sodium Hypochlorite Group |
| Moringa Oleifera Leaf Extractextract 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. | Biological | Moringa oleifera Leaf Extract Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hypochlorite and Moringa Oleifera Leaf Extract in people with Dental Caries and Pulp Necrosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alawi Taha Alaidarous T Principal Investigator, BDS (+966500969988, al-alawi.ta@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zone of inhibition against Coagulase-Negative Staphylococci (time frame: "Day 1 (Pre- and post-irrigation samples collected during the same visit)"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.