An Early Feasibility Evaluation of a Novel 3rdMolarTooth Bud Ablation Procedure

Study Overview
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Brief Summary
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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.

Official Title
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An Early Feasibility Evaluation of a Novel 3rdMolarTooth Bud Ablation Procedure

Conditions
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Molar, Third

Intervention / Treatment
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* Device: 3TBA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 7 and 13 years of age Subject has radiographic evidence of at least one mandibular 3rd molar tooth bud Exclusion Criteria: Subject use of articaine is contraindicated (known hypersensitive to products containing sulfites). Subject has any condition which, in the opinion of the Investigator, would prevent adequate performance of the procedure or affect the health and/or safety of the subject.-

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3TBA Procedure<br> | Device: 3TBA<br>* Induce third molar tooth bud agenesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Proximal second molars continue to erupt normally Proximal second molars have no radiographic evidence of crown alteration Surgical site is completely healed over on visual exam Radiographic assessment of the surgical site is WNL expected or post op healing No adverse events related to the 3TBA procedure No reported neurological changes to tongue or lip | 12 weeks |