Molar, ThirdZero3NCT05374993
A First-in-Human Study of a Novel 3rd Molar Tooth Bud Ablation Procedure
A study testing Zero3 System in people with Molar, Third, run by TriAgenics Inc at 1 site in Panama.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar, Third
- What is being tested?
- Zero3 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePanama
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant has radiographic evidence of at least one mandibular 3rd molar tooth bud between 4 and 8 mm in largest diameter, which typically presents in children between 8 and 12 years of age, and
- Participant is free from any clinically significant health or behavioral problems that the investigator determines will be inappropriate for inclusion in the Study, and
- Participant has normal facial and oral anatomy and is free from any abnormality or condition which may impact the performance of the procedure, and
- Participant's parent or legal guardian is willing and able to sign the approved Informed Consent Form ("ICF") and the Participant will agree with the Participant Assent Form and the Participant is willing and able to provide age-appropriate assent and comply with required study procedures and follow-up.
Who cannot join
- Participant where use of local anesthetic is contraindicated, or
- Participant has any behavioral or medical condition which, in the opinion of the Investigator, would prevent adequate performance of the procedure or affect the health and/or safety of the Participant, or
- Participants with orthodontics (traditional braces or clear aligners), or
- Participant is immunocompromised, has a history of or potential for bone tissue defects, or has any known sensitivities to anesthetic agents, or Exclusion Post Radiological Exam (by Sponsor) from review of the LL8/#17 and LR8/#32 tooth buds
- Adjacent 2nd molar has incomplete enamel formation, or
- Tooth bud has enamel formation (calcification) visible on radiographs, or
- Tooth bud has a diameter of less than 4 mm or greater than 8 mm, or
- Tooth bud has less than 3 mm separation from the inferior alveolar nerve canal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Panama1 site
Universidad Interamericana de Panamá
Panama City, Panamá Province
ARISTIDES JOEL CASTILLO VÁSQUEZ, DDS, +507 6781-8001, Dr.ajcastillov@gmail.com
VIRGILIO B. CASTILLERO D, DDS, +50766799195, vicas21@yahoo.com
About this study
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.
Read the detailed description
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.
- Conditions
- Molar, Third
- Being tested
- Zero3 System
- Keywords
- microwave ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero3 SystemDevice
Induce third molar tooth bud agenesis
| Study group | Role | What they receive |
|---|---|---|
| Zero3 Procedure | Experimental | Not described Receives: Device: Zero3 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Before being released on the day of the procedure and then 1, 7, 30, and 90 days after the procedure
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 and 90 days after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar, ThirdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective study
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriAgenics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leigh Colby, DDS, Study director, TriAgenics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374993
- Sponsor's protocol ID
- TP-025
- Acronym
- Zero3
- Status last verified
- Sep 2026
- First submitted
- 6 May 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No