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The goal of this clinical trial is to compare the efficacy of lesion sterilization and tissue repair (LSTR) antibiotic paste versus zinc oxide eugenol (ZOE) pulpectomy for the treatment of primary molars with pulp necrosis in pediatric patients.
The main questions it aims to answer are:
Researchers will compare LSTR therapy (Group A) with ZOE pulpectomy (Group B) to determine which treatment provides better clinical and radiographic outcomes after six months.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSTR therapy | Experimental | Participants in this group receive CTZ antibiotic paste placed in the pulp chamber after irrigation. |
|
| Zinc Oxide Eugenol (ZOE) Pulpectomy | Active Comparator | Participants in this group receive conventional pulpectomy with ZOE paste placed in the root canals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A - LSTR Therapy (CTZ Paste) | Drug | Placement of CTZ antibiotic paste (chloramphenicol, tetracycline, zinc oxide mixed with eugenol) in the pulp chamber after irrigation with 3% sodium hypochlorite, followed by restoration with resin-modified glass ionomer cement. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinical Success | Clinical success will be assessed based on the absence of sinus tract, soft tissue swelling, or edema associated with the treated primary molar during follow-up clinical examination. | 6 months |
| Number of Participants with Radiographic Success | Radiographic success will be assessed by reduction or complete disappearance of the initial periapical radiolucency and absence of any newly developed radiolucency on follow-up periapical radiographs of the treated tooth. | 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Periapical Radiolucency | Change in the size of periapical radiolucency from baseline to follow-up radiographs in treated primary molars. | baseline and 6 months |
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Inclusion Criteria:
• Children of both genders
Exclusion Criteria:
• Children who have a physical or mental change.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2025 |
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| Group B - ZOE Pulpectomy | Procedure | Intervention: Conventional pulpectomy including working length determination, canal debridement with K-files and 3% sodium hypochlorite irrigation, followed by obturation with zinc oxide eugenol paste and final restoration with resin-modified glass ionomer cement. |
|
| Mar 11, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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