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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Molar, Third

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm prospective study

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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3TBA Procedure

Group Type EXPERIMENTAL

3TBA

Intervention Type DEVICE

Induce third molar tooth bud agenesis

Interventions

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3TBA

Induce third molar tooth bud agenesis

Intervention Type DEVICE

Eligibility Criteria

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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.-

Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes