The GentleWave Registry

The GentleWave Post-Market Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02557152

Enrollment

500

Registered

2015-09-23

Start date

2015-09-30

Completion date

2018-07-31

Last updated

2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Canal

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.

Interventions

DEVICEGentleWave System Treatment

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* One or more teeth treated with the Sonendo GentleWave System

Exclusion criteria

* Institutionalized patients or prisoners

Design outcomes

Primary

Measure	Time frame	Description
Healing	24 months	Radiographic analysis and clinical signs and symptoms at 24 months

Secondary

Measure	Time frame	Description
Retreatment Rates	24 months	Rate of retreatment at 24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026