Nonvital Primary Molars
Conditions
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.
Interventions
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.
DRUGSodium 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Periapical Radiographic Changes | 6 and 12 months | Evaluated using digital radiographs. |
| Internal/External Root Resorption | 6 and 12 months | Identified via radiographic analysis. |
Countries
Egypt
Contacts
Primary ContactLama H Fouad, Bachelor of Dental Surgery
Backup ContactProf.Dr. Walid Ali Mohamed Fouad
Outcome results
None listed