Evaluation of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite in Pulpectomy of Nonvital Primary Molars

April 24, 2025 updated by: Lama Hatem Fouad Sobhi, Cairo University

Clinical and Radiographic Evaluation of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite as Intracanal Irrigations in Pulpectomy of Nonvital Primary Molars: A Randomized Clinical Trial

This randomized clinical trial aims to compare the clinical and radiographic success of Moringa Oleifera leaf extract with Sodium Hypochlorite as intracanal irrigants in pulpectomy of nonvital primary molars in children aged 3-7 years. The study evaluates both clinical parameters (pain, swelling, mobility) and radiographic healing (periapical changes, root resorption) over 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Effective disinfection during pulpectomy of primary molars is essential for treatment success. Sodium hypochlorite is the gold standard intracanal irrigant but presents concerns regarding cytotoxicity and taste. Moringa Oleifera, a natural agent with antimicrobial, antioxidant, and anti-inflammatory properties, may offer a biocompatible alternative. This study is a parallel-design, randomized clinical trial evaluating 50 teeth in children aged 3-7 years. Patients will be randomly allocated to either 1% Sodium Hypochlorite or Moringa Oleifera leaf extract for intracanal irrigation. Clinical and radiographic outcomes will be assessed at 3, 6, and 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Giza
      • El-Manial, Giza, Egypt, 12613
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cooperative children aged between 3-7 years
  • Males/Females.
  • Primary molars necessitating pulpectomy diagnosed with deep dental caries with pulp necrosis and periapical pathosis or both.
  • Systemically healthy children

Exclusion Criteria:

  • Medically compromised and uncooperative children
  • Tooth indicated for extraction due to root resorption more than two thirds of the root, teeth near exfoliation, deep subgingival caries hindering proper coronal seal.
  • Mobile teeth (Miller's Grade 2 or more)
  • Previous pulp therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moringa Oleifera Leaf Extract Irrigation
Participants in this arm will receive pulpectomy treatment using Moringa Oleifera leaf extract as the intracanal irrigant. The extract will be used to irrigate the root canals after working length determination, using a 3 ml syringe with a side-vented needle to minimize the risk of apical extrusion. Mechanical preparation will follow using a rotary system, and the canals will be obturated with Metapex and restored with stainless steel crowns.
Drug: Moringa Oleifera Leaf Extract
A plant-based extract derived from Moringa Oleifera leaves, used as an intracanal irrigant during pulpectomy procedures in primary molars. It is administered using a 3 ml syringe with a side-vented needle following canal preparation and working length determination. This intervention aims to evaluate the clinical and radiographic efficacy of a natural, biocompatible alternative to conventional chemical irrigants.
Other Names:
  • Moringa extract
  • Natural intracanal irrigant
Active Comparator: Sodium Hypochlorite Irrigation
Participants in this arm will receive pulpectomy treatment using 1% Sodium Hypochlorite as the intracanal irrigant. The irrigant will be applied in the same manner as in the experimental group, using a 3 ml syringe and side-vented needle following root canal instrumentation. Mechanical preparation, obturation with Metapex, and stainless steel crown placement will be performed identically to the experimental group.
Drug: Sodium Hypochlorite 1%
A 1% concentration of Sodium Hypochlorite solution used as a standard intracanal irrigant in pediatric endodontics. It is administered using a 3 ml syringe with a side-vented needle after canal instrumentation. Known for its strong antimicrobial and tissue-dissolving properties, Sodium Hypochlorite serves as the active comparator in this study.
Other Names:
  • NaOCl
  • Standard chemical irrigant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 3, 6, 12 months
Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-point scale where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate worse pain outcomes. Pain levels will be recorded at 3, 6, and 12 months post-treatment.
3, 6, 12 months
Soft Tissue Healing
Time Frame: 3, 6, 12 months
Visual and palpation-based assessment for swelling, sinus tract, or redness.
3, 6, 12 months
Pain on Percussion & Mobility
Time Frame: 3, 6, 12 months
Tested clinically for tenderness and abnormal mobility.
3, 6, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Periapical Radiographic Changes
Time Frame: 6 and 12 months
Evaluated using digital radiographs.
6 and 12 months
Internal/External Root Resorption
Time Frame: 6 and 12 months
Identified via radiographic analysis.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRE - Moringa Vs NaOCl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be securely stored and only accessible by the research team for analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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