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Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study

NCT04966169 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-08-24

No results posted yet for this study

Summary

The purpose of this 12-month prospective cohort study is to evaluate post-operatory pain, patient satisfaction, and treatment outcomes (i.e., healing) when the newly-developed, 510k FDA-approved multisonic energy GentleWAve System (Sonendo, Inc., Laguna Hills, CA) is used in complex root canal procedures.

Conditions

  • Apical Periodontitis

Interventions

DEVICE

GentleWave System

The GentleWave hydrodynamic cavitation system is a 510k FDA-approved multisonic energy system that is used in complex root canal procedures.

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Fabricio Teixeira, DDS,MS,PhD · University of Iowa College of Dentistry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04966169 on ClinicalTrials.gov