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

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.

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Key information

Conditions

Molar, Third

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is between 8 and 12 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.-

Treatment and study plan

Zero3 System

Device

Induce third molar tooth bud agenesis

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

TriAgenics Inc

Industry

Registry information

Acronym: Zero3

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 16, 2022
Registry last updated: Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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