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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Periapical Radiographic Changes | Evaluated using digital radiographs. | 6 and 12 months |
| Internal/External Root Resorption | Identified via radiographic analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | El-Manial | Giza Governorate | 12613 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9484133 | Background | 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. | |
| 36960331 | 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. |
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The data will be securely stored and only accessible by the research team for analysis.
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| 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. |
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| 6 and 12 months |