Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT02285595
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2014-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy
Sponsor:
Sonendo, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Study Comparing Healing After Treatment With the Sonendo GentleWave™ System as Compared to a Traditional Root Canal Therapy Literature Control
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPREME
Brief Summary:
A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.
Detailed Description:
A prospective, non-significant risk device, literature controlled, study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.
All patients will receive root canal therapy with the Sonendo GentleWave System. All patients will be followed for 24 months post procedure.
All patients will receive root canal therapy with the Sonendo GentleWave System. All patients will be followed for 24 months post procedure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: