An interventional study of Zero3 System in Molar, Third, sponsored by TriAgenics Inc. Not yet recruiting at 1 site in Panama. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by TriAgenics Inc · Not applicable, Interventional, and Device feasibility
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). The main question it aims to answer is the safety of the ablation procedure. Also effectiveness of 3rd molar tooth bud ablation and resulting agenesis will be assessed.
TriAgenics has developed a highly controllable, safe means of suppressing development of third molar tooth buds. Its unique Zero3 micro-ablation handpiece delivers microwave energy that results in spherical zones of ablation. The Zero3 treatment works by gently warming the wisdom tooth bud from the center outwards in a controlled fashion to ablate the tooth bud tissue and prevent it from being able to form a tooth.
The image-guided Zero3 procedure employs a simple puncture of the tooth bud followed by a 25-95 second ablation cycle. Because of the high level of control enabled by the image-guided ablation, the ablation zone matches the size of the tooth bud with no unplanned cell damage outside the bony crypt of the tooth bud. This results in a procedure with a fully enclosed surgical field with virtually no surgical trauma.
Microwave ablation of tooth buds for eligible children will be performed on day 0 and adverse events and progression of tooth bud effects will be monitored over time after the procedure. Participants will return to the dentist at 1, 7, 30, and 90 days post-procedure for assessment of the treatment site. Participants will exit the study at 90 days unless further monitoring is warranted. If further monitoring does occur, it will only be for an additional 90 days.
This is the only study on the registry with TriAgenics Inc as lead sponsor.
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Exclusion Criteria:
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Zero3 System
Induce third molar tooth bud agenesis
Incidence of puncture site wound healing
The site of the puncture of the electrode will be visually evaluated by the treating dentist. Success is defined as greater than 90% healing of the puncture site by 90 days after the procedure by visual evaluation by the investigator.
Time frame: 1, 7, 30, and 90 days after the procedure
Incidence of Adverse Events
Serious adverse events related to the procedure. Reviewed by the Medical Monitor and classify each as serious or not serious.
Time frame: 1, 7, 30, and 90 days after the procedure.
Pain during and after the procedure
The participant will be asked to rank the pain using the Faces Pain Scale-Revised after and then at each monitoring visit. Mean pain scale will be determined for all participants.
Time frame: Before being released on the day of the procedure and then 1, 7, 30, and 90 days after the procedure
Radiographic evidence of treated third molar formation after treatment
Periodical x-ray images will be taken at intervals after the treatment to document any third molar mineralization tooth structure formation after the treatment. Presence of tooth structure will be assessed by the Sponsor, the investigator, and the Medical Monitor.
Time frame: 30 and 90 days after the treatment
Diameter of bony crypts after treatment
The maximum diameter of the boney crypt will be compared on per-op and post-op x-rays. Reduction in diameter of boney crypts will be measured and calibrated using the first molar anterior/posterior size as a reference.
Time frame: 30 and 90 days after the treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
Completion moved once since we started tracking on Sep 25, 2026: Sep 2027 → Jun 2027, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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