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| ID | Type | Description | Link |
|---|---|---|---|
| OCR34882 | Other Identifier | UF OnCore |
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| Name | Class |
|---|---|
| NuSmile, Ltd and Avalon Biomed | UNKNOWN |
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When proximal carious lesions of primary molars are located in close proximity to the cementum enamel junction (CEJ), marginal seal is challenging and extraction is recommended. Pulpotomy is indicated for vital primary teeth to preserve them in function. The goal of this study is to monitor the long-term effect of intentional bioactive cement pulpotomies and crown coverage performed on vital and asymptomatic carious primary molars with gingival margins close to or at the CEJ
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulpotomy | Experimental | Group A: The patient will benefit from an experimental treatment: a Pulpotomy. The pulpotomy aims at removing the coronal part of the pulp (the pulp present in the pulp chamber) and filling the pulp chamber with a bioactive material. |
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| Control Group | Active Comparator | Group B: Extracted teeth will serve as controls, and information regarding the need or not of space maintenance, and the impact on the occlusion and eruption of the succedaneous permanent tooth will be noted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulpotomy | Procedure | Pulpotomy using bioactive bioceramic cement of 1.5 mm layer of a newly FDA approved calcium-based silicate cement (Nusmile NeoPutty) will be placed on the pulp chamber floor and canals' orifices for pulp and root therapy. Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health.This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, complete caries removal and then access to the pulp chamber using drills. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic examination for each recall visit | Evaluation of asymptomatic tooth in the mouth for presence of infection (bite -wing/periapical radiograph(s) | up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcio Guelmann | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D011671 | Pulpitis |
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D011672 | Pulpotomy |
| ID | Term |
|---|---|
| D004708 | Endodontics |
| D003813 | Dentistry |
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| Extraction and placement of space maintainer | Procedure | If during the pulpotomy procedure, hemostasis is not obtainable, or signs of advanced pulp degeneration such as dark and limited or no bleeding from canals, the pulp will be diagnosed as chronically inflamed or necrotic, and tooth will be extracted. As part of the standard of care after extractions of primary molars, space maintenance will be assessed, and a space maintainer fabricated if indicated. Extracted teeth will serve as controls, and information regarding the need or not of space maintenance. |
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