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

NCT06948526 | Not Yet Recruiting

• 1 other identifier: CRE - Moringa Vs NaOCl
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nonvital Primary Molars

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain

  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

  Visual and palpation-based assessment for swelling, sinus tract, or redness.

  3, 6, 12 months

• Pain on Percussion & Mobility

  Tested clinically for tenderness and abnormal mobility.

  3, 6, 12 months

Secondary Outcomes (2)

• Periapical Radiographic Changes

  6 and 12 months

• Internal/External Root Resorption

  6 and 12 months

Study Arms (2)

Moringa Oleifera Leaf Extract Irrigation

EXPERIMENTAL

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

Sodium Hypochlorite Irrigation

ACTIVE COMPARATOR

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%

Interventions

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.

Also known as: Moringa extract, Natural intracanal irrigant

Moringa Oleifera Leaf Extract Irrigation

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.

Also known as: NaOCl, Standard chemical irrigant

Sodium Hypochlorite Irrigation

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

El-Manial, Giza Governorate, 12613, Egypt

Location

Related Publications (2)

• Peretz B, Yakir O, Fuks AB. Follow up after root canal treatment of young permanent molars. J Clin Pediatr Dent. 1997 Spring;21(3):237-40.

  PMID: 9484133 BACKGROUND

• Alharbi AM, Alharbi TM, Alqahtani MS, Elfasakhany FM, Afifi IK, Rajeh MT, Fattouh M, Kenawi LMM. A Comparative Evaluation of Antibacterial Efficacy of Moringa oleifera Leaf Extract, Octenidine Dihydrochloride, and Sodium Hypochlorite as Intracanal Irrigants against Enterococcus faecalis: An In Vitro Study. Int J Dent. 2023 Mar 14;2023:7690497. doi: 10.1155/2023/7690497. eCollection 2023.

  PMID: 36960331 BACKGROUND

Central Study Contacts

Lama H Fouad, Bachelor of Dental Surgery

CONTACT

+2001201112766; lama.sobhi@dentistry.cu.edu.eg

Prof.Dr. Walid Ali Mohamed Fouad

CONTACT

+2001100338446; walid.fouad@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)