MedPath

The GentleWave Registry

Completed
Conditions
Root Canal
Interventions
Device: GentleWave System Treatment
Registration Number
NCT02557152
Lead Sponsor
Sonendo, Inc.
Brief Summary

The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage. The registry population includes up to 500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical sites in the United States.

Detailed Description

The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage.

Up to 25 clinical sites in the United States. Up to 500 subjects that have been treated with the Sonendo GentleWave System. To assess outcomes for teeth treated with the GentleWave System in a commercial setting.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
500
Inclusion Criteria
  • One or more teeth treated with the Sonendo GentleWave System
Exclusion Criteria
  • Institutionalized patients or prisoners

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients that were treated with the GentleWave SystemGentleWave System Treatment-
Primary Outcome Measures
NameTimeMethod
Healing24 months

Radiographic analysis and clinical signs and symptoms at 24 months

Secondary Outcome Measures
NameTimeMethod
Retreatment Rates24 months

Rate of retreatment at 24 months

Trial Locations

Locations (3)

Randy Garland, DDS

🇺🇸

Encinitas, California, United States

SC Endododontics

🇺🇸

Santa Ana, California, United States

Stacey Woo, DDS

🇺🇸

Whittier, California, United States

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