A First-in-Human Study of a Novel 3rd Molar Tooth Bud Ablation Procedure
ConditionMolar, Third
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorTriAgenics Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Zero3 System
DeviceInduce third molar tooth bud agenesis
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Zero3 ProcedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 procedure2
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.3
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 procedureSecondary outcomes
1
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 treatment2
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 treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: