An Early Feasibility Evaluation of a Novel 3rdMolarTooth Bud Ablation Procedure

NCT05374993 | Withdrawn FDA Device

• 1 other identifier: TP-015
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-arm prospective study will enroll a minimum of 7 and a maximum 10 subjects between the ages of 7 and 13 years of age with radiographic evidence of mandibular 3rd molar tooth bud development without enamel formation. Each subject will undergo a 3TBA procedure for each qualifying mandibular 3rd molar tooth buds. Each subject will receive treatment for qualifying mandibular tooth buds during the same session. Subjects will be followed for a minimum of 12 weeks post treatment.

Conditions

Molar, Third

Outcome Measures

Primary Outcomes (2)

• Tooth Structure Development Assessment

  Efficacy assessment will be performed based on periapical X-rays from Follow-up Visit 3 (12-week post treatment). Effectiveness Assessment will consist of evaluation of Tooth Structure Development and Bony Crypt In Growth using the following scale. Tooth Structure Development Assessment Scale for 3rd Molar: "0" = No radiographic evidence. "1" = Minimal or trace level of detectable radiographic evidence. "2" = Moderate or intermediate level of detectable radiographic evidence of mineralized tooth structure formation with crown formation to be less than 50% complete. "3" = Advanced level of detectable radiographic evidence of mineralized tooth structure formation with enamel formation estimated to be 50% or more complete. Success is defined as a score of "0" or "1" on Tooth Structure Development scale at Follow-up Visit 3 (12-week post treatment). Each treated tooth bud is evaluated individually.

  12 weeks

• Bony Crypt Growth Assessment

  Efficacy assessment will be performed based on periapical X-rays from Follow-up Visit 3 (12-week post treatment). Effectiveness Assessment will consist of evaluation of Bony Crypt In Growth using the following scales. Tooth Structure Development Assessment Scale for 3rd Molar: "0" = No radiographic evidence. "1" = Minimal or trace level of detectable radiographic evidence of mineralized tooth structure formation. "2" = Moderate or intermediate level of detectable radiographic evidence of mineralized tooth structure formation with crown formation to be less than 50% complete. "3" = Advanced level of detectable radiographic evidence of mineralized tooth structure formation with enamel formation estimated to be 50% or more complete. N/I = Not Interpretable. N/A = Not Applicable. Success is defined as a score of "0" or "1" on Bony Crypt Growth Assessment scales at Follow-up Visit 3 (12-week post treatment). Each treated tooth bud is evaluated individually.

  12 weeks

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  12 weeks

Study Arms (1)

3TBA Procedure

EXPERIMENTAL

Device: 3TBA

Interventions

3TBA DEVICE

Induce third molar tooth bud agenesis

3TBA Procedure

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject is between 7 and 13 years of age
• Subject has radiographic evidence of at least one mandibular 3rd molar tooth bud

You may not qualify if:

• 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.-

Sponsors & Collaborators

• TriAgenics Inc: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm prospective study

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 16, 2022
• Study Start: November 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share