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OpenTrials
Completed

NCT Number: NCT02557152

The GentleWave Registry

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.

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Key information

Conditions

Root Canal

Sex eligibility

All sexes

Study type

Observational

Primary location

Randy Garland, DDS, Encinitas, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • One or more teeth treated with the Sonendo GentleWave System

Exclusion criteria

  • Institutionalized patients or prisoners

Treatment and study plan

GentleWave System Treatment

Device

Primary outcomes

  1. Healing

    Time frame: 24 months

    Radiographic analysis and clinical signs and symptoms at 24 months

Secondary outcomes

  1. Retreatment Rates

    Time frame: 24 months

    Rate of retreatment at 24 months

Sponsors and collaborators

Lead sponsor

Sonendo, Inc.

Industry

Registry information

Official study title

The GentleWave Post-Market Registry

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2015
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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