Evaluation of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite in Pulpectomy of Nonvital Primary Molars
- Conditions
- Nonvital Primary Molars
- Interventions
- Drug: Sodium Hypochlorite 1%
- Registration Number
- NCT06948526
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moringa Oleifera Leaf Extract Irrigation Moringa Oleifera Leaf Extract 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. Sodium Hypochlorite Irrigation Sodium Hypochlorite 1% 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.
- Primary Outcome Measures
Name Time Method Postoperative Pain 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 3, 6, 12 months Visual and palpation-based assessment for swelling, sinus tract, or redness.
Pain on Percussion & Mobility 3, 6, 12 months Tested clinically for tenderness and abnormal mobility.
- Secondary Outcome Measures
Name Time Method Periapical Radiographic Changes 6 and 12 months Evaluated using digital radiographs.
Internal/External Root Resorption 6 and 12 months Identified via radiographic analysis.
Trial Locations
- Locations (1)
Faculty of Dentistry, Cairo University
🇪🇬El-Manial, Giza, Egypt