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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics Committee | Other Identifier | Marmara University Faculty of Dentistry |
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This study aims to compare the clinical and radiographic success of two commonly used pulpotomy agents, ferric sulfate (FS) and sodium hypochlorite (NaOCl), in vital primary molars. Pulpotomy is a widely used vital pulp therapy procedure in pediatric dentistry to preserve primary teeth until their natural exfoliation.
The study will include children aged 4-9 years who previously received pulpotomy treatment using either FS or NaOCl at Marmara University Faculty of Dentistry. No additional treatment will be performed as part of this study. Patients will be followed during routine clinical visits at 6, 12, and 24 months.
Clinical outcomes such as pain, mobility, and infection, as well as radiographic findings including resorption and radiolucency, will be evaluated. The results of this study are expected to provide evidence for the effectiveness of these materials and support clinical decision-making in pediatric dental practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Sulfate Group | Children aged 4-9 years who received pulpotomy treatment in vital primary molars using 15.5% ferric sulfate as part of routine clinical care. | ||
| Sodium Hypochlorite Group | Children aged 4-9 years who received pulpotomy treatment in vital primary molars using 5% sodium hypochlorite as part of routine clinical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical and Radiographic Success Rate of Pulpotomy | The primary outcome is the clinical and radiographic success of pulpotomy-treated primary teeth. Clinical success is defined as the absence of pain, mobility, fistula, abscess, or tenderness to percussion. Radiographic success is defined as the absence of internal or external resorption, periapical or furcal radiolucency, and other pathological findings. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate | Evaluation of clinical success based on absence of pain, mobility, fistula, abscess, and tenderness. | 6, 12, and 24 months |
| Radiographic Success Rate | Evaluation of radiographic success based on absence of pathological findings such as resorption and radiolucency. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of children aged 4-9 years who were treated at the Department of Pediatric Dentistry, Marmara University Faculty of Dentistry. These participants had previously undergone pulpotomy treatment in vital primary molars using either ferric sulfate or sodium hypochlorite as part of routine clinical care.
The study includes patients with available clinical records and diagnostic radiographs, and who are followed during routine recall visits at 6, 12, and 24 months. No additional interventions are performed as part of the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28292337 | Background | Coll JA, Seale NS, Vargas K, Marghalani AA, Al Shamali S, Graham L. Primary Tooth Vital Pulp Therapy: A Systematic Review and Meta-analysis. Pediatr Dent. 2017 Jan 15;39(1):16-123. |
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Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The study involves pediatric participants, and all data are anonymized and handled in accordance with ethical guidelines and data protection regulations.
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 6, 12, and 24 months |