Clinical trial NCT06948526: Evaluation of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite in Pulpectomy of Nonvital Primary Molars
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nonvital Primary Molars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: 3, 6, 12 months
measure: Soft Tissue Healing
timeFrame: 3, 6, 12 months
measure: Pain on Percussion & Mobility
timeFrame: 3, 6, 12 months
Secondary outcomes:
measure: Periapical Radiographic Changes
timeFrame: 6 and 12 months
measure: Internal/External Root Resorption
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: El-Manial
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Giza
Study officials:
References:
citation: 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.
citation: 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.