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

TriAgenics

Status: Withdrawn

Conditions: Molar, Third

Treatments: Device: 3TBA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05374993

TP-015

Details and patient eligibility

About

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.

Sex: All

Ages: 7 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is between 7 and 13 years of age
2. Subject has radiographic evidence of at least one mandibular 3rd molar tooth bud

Exclusion criteria

1. Subject use of articaine is contraindicated (known hypersensitive to products containing sulfites).
2. 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.-

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

3TBA Procedure

Experimental group

Treatment:

Device: 3TBA