An Early Feasibility Evaluation of a Novel 3rdMolarTooth Bud Ablation Procedure
- Conditions
- Molar, Third
- Interventions
- Device: 3TBA
- Registration Number
- NCT05374993
- Lead Sponsor
- TriAgenics Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Subject is between 7 and 13 years of age
- Subject has radiographic evidence of at least one mandibular 3rd molar tooth bud
- 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.-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 3TBA Procedure 3TBA -
- Primary Outcome Measures
Name Time Method Tooth Structure Development Assessment 12 weeks 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.Bony Crypt Growth Assessment 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 12 weeks * 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