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

NCT ID: NCT06948526

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nonvital Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Moringa Oleifera Leaf Extract

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Sodium Hypochlorite 1%

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Moringa extract Natural intracanal irrigant NaOCl Standard chemical irrigant

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Lama Hatem Fouad Sobhi

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

El-Manial, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Lama H Fouad, Bachelor of Dental Surgery

Role: CONTACT

+2001201112766

Prof.Dr. Walid Ali Mohamed Fouad

Role: CONTACT

+2001100338446

References

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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.

Reference Type BACKGROUND
PMID: 9484133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36960331 (View on PubMed)

Other Identifiers

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CRE - Moringa Vs NaOCl

Identifier Type: -

Identifier Source: org_study_id

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