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This single-arm prospective study will enroll a minimum of 7 and a maximum 10 subjects between the ages of 7 and 13 years of age with radiographic evidence of mandibular 3rd molar tooth bud development without enamel formation. Each subject will undergo a 3TBA procedure for each qualifying mandibular 3rd molar tooth buds. Each subject will receive treatment for qualifying mandibular tooth buds during the same session. Subjects will be followed for a minimum of 12 weeks post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3TBA Procedure | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3TBA | Device | Induce third molar tooth bud agenesis |
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| Measure | Description | Time Frame |
|---|---|---|
| Tooth Structure Development Assessment | Efficacy assessment will be performed based on periapical X-rays from Follow-up Visit 3 (12-week post treatment). Effectiveness Assessment will consist of evaluation of Tooth Structure Development and Bony Crypt In Growth using the following scale. Tooth Structure Development Assessment Scale for 3rd Molar: "0" = No radiographic evidence. "1" = Minimal or trace level of detectable radiographic evidence. "2" = Moderate or intermediate level of detectable radiographic evidence of mineralized tooth structure formation with crown formation to be less than 50% complete. "3" = Advanced level of detectable radiographic evidence of mineralized tooth structure formation with enamel formation estimated to be 50% or more complete. Success is defined as a score of "0" or "1" on Tooth Structure Development scale at Follow-up Visit 3 (12-week post treatment). Each treated tooth bud is evaluated individually. | 12 weeks |
| Bony Crypt Growth Assessment | Efficacy assessment will be performed based on periapical X-rays from Follow-up Visit 3 (12-week post treatment). Effectiveness Assessment will consist of evaluation of Bony Crypt In Growth using the following scales. Tooth Structure Development Assessment Scale for 3rd Molar: "0" = No radiographic evidence. "1" = Minimal or trace level of detectable radiographic evidence of mineralized tooth structure formation. "2" = Moderate or intermediate level of detectable radiographic evidence of mineralized tooth structure formation with crown formation to be less than 50% complete. "3" = Advanced level of detectable radiographic evidence of mineralized tooth structure formation with enamel formation estimated to be 50% or more complete. N/I = Not Interpretable. N/A = Not Applicable. Success is defined as a score of "0" or "1" on Bony Crypt Growth Assessment scales at Follow-up Visit 3 (12-week post treatment). Each treated tooth bud is evaluated individually. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
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Inclusion Criteria:
Exclusion Criteria:
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Single-arm prospective study
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| 12 weeks |