A First-in-Human Study of a Novel 3rd Molar Tooth Bud Ablation Procedure (Zero3)

TriAgenics

Status: Begins enrollment in 1 month

Conditions: Molar, Third

Treatments: Device: Zero3 System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05374993

TP-025

Details and patient eligibility

About

The goal of this single-arm prospective, non-randomized study is to demonstrate microwave ablation and agenesis of 3rd molar tooth buds using the Zero3 System in participants that have 3rd molar tooth bud(s) without the formation of enamel (calcification). Typically ages 8 to 12 years. The main question it aims to answer is:

• Effectiveness of 3rd Molar ablation and agenesis

Participants will

• Have CBCT and IOS scans to determine the presence of 3rd molar tooth buds without enamel formation (calcification)
• If indicated, have the Zero3 procedure to ablate the 3rd molar tooth buds
• Visit the dentist at 7, 30, and 90 days to observe 3rd molar agenesis. Participants will exit the study at 90 days.

Enrollment: 35 estimated patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is between 8 and 12 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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35 participants in 1 patient group

Zero3 Procedure

Experimental group

Treatment:

Device: Zero3 System