Molar, Third
Conditions
Brief 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). 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.
Interventions
DEVICEZero3 System
Induce third molar tooth bud agenesis
Sponsors
TriAgenics Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single-arm prospective study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound healing and adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of 3rd molar tooth bud agenesis | 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. |
Outcome results
None listed