Not Yet Recruiting

NCT Number: NCT06948526

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Nonvital Primary Molars

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

El-Manial, Giza Governorate, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moringa Oleifera Leaf Extract

Drug

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

Sodium Hypochlorite 1%

Drug

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

Primary outcomes

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.
Soft Tissue Healing

Time frame: 3, 6, 12 months

Visual and palpation-based assessment for swelling, sinus tract, or redness.
Pain on Percussion & Mobility

Time frame: 3, 6, 12 months

Tested clinically for tenderness and abnormal mobility.

Secondary outcomes

Periapical Radiographic Changes

Time frame: 6 and 12 months

Evaluated using digital radiographs.
Internal/External Root Resorption

Time frame: 6 and 12 months

Identified via radiographic analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Lama H Fouad, Bachelor of Dental Surgery

CONTACT

[email protected]

+2001201112766

Prof.Dr. Walid Ali Mohamed Fouad

CONTACT

[email protected]

+2001100338446

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 29, 2025
Registry last updated: Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.