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

September 15, 2026 updated by: TriAgenics Inc

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 13 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zero3 Procedure
Device: Zero3 System
Induce third molar tooth bud agenesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of wound healing and adverse events
Time Frame: 90 Days
  • Incidence of puncture site wound healing complete post procedure at day 1, day 7, day 30, day 90 as visually evaluated by treating dentist. Success is defined as greater than 90% healing of the puncture site by day 90 post-procedure by visual evaluation by the Investigator.
  • Incidence of serious adverse events related to the Zero3 procedure at day 1, day 7, day 30, day 90. Success is defined as an incidence of less 5%. A Medical Monitor will review all adverse events and classify each as serious or not serious.
  • Pain will be assessed using the Faces Pain Scale- Revised, with mean pain scale determined for all Participants.
90 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of 3rd molar tooth bud agenesis
Time Frame: 90 days
  • Incidence of radiographic evidence of any third molar mineralized tooth structure formation at day 30, day 90 as seen on periapical x-ray by TriAgenics dentist and verified by the treating dentist and the Medical Monitor.
  • The maximum diameter of the bony crypt on day 30 and day 90 post-op x-rays are reduced in size compared to the pre-op x-ray. Measurements are calibrated using the first molar anterior/posterior size as a reference.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriAgenics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TP-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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