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

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.

Study Overview

• Status: Withdrawn
• Conditions: Molar, Third
• Intervention / Treatment: Device: 3TBA

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subject is between 7 and 13 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.-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3TBA Procedure	Device: 3TBA; Induce third molar tooth bud agenesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Proximal second molars continue to erupt normally; Proximal second molars have no radiographic evidence of crown alteration; Surgical site is completely healed over on visual exam; Radiographic assessment of the surgical site is WNL expected or post op healing; No adverse events related to the 3TBA procedure; No reported neurological changes to tongue or lip	12 weeks

Collaborators and Investigators

• Sponsor: TriAgenics Inc

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TP-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes