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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

50

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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