Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT04966169
Status:
TERMINATED
Last Update Posted:
2025-08-24
First Post:
2021-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study
Sponsor:
University of Iowa
Organization:
Study Overview
Official Title:
Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study
Status:
TERMINATED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Departure from the University of Iowa
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Apical Periodontitis (AP) is a disease where multiple types of bacteria, including those that can live without oxygen, create a bacterial film on the tissues around teeth. These bacteria colonize the dying pulp tissue, invade channels within teeth and other openings, and create an inflammatory response of the tissues surrounding the teeth. Therefore, the primary goal of endodontic treatment is to reduce bacteria numbers by removing remaining tissues, bacterial films, and infected dentine (i.e., layer of tooth below the enamel). Healing of apical periodontitis (AP) is expected, in the majority of cases, if proper bacterial disinfection is accomplished.
Elimination of these bacteria can be achieved by a combined action of several treatments. Lately, irrigation and mechanical instrumentation techniques have been developed with this intention. Some new technologies are based on the concept of using minimally-invasive instruments with hydrodynamic cavitation generating a broad spectrum of sound waves within the degassed fluid inside of the tooth. However, there is not enough evidence in the literature to support its efficacy.
The hypothesis of this study is that the GentleWave (GW) hydrodynamic cavitation system (Sonendo, Inc., Laguna Hills, CA) will achieve a high success rate in treating and healing apical periodontitis (AP), a disease where a bacterial film is formed on the tissues around the teeth.
Elimination of these bacteria can be achieved by a combined action of several treatments. Lately, irrigation and mechanical instrumentation techniques have been developed with this intention. Some new technologies are based on the concept of using minimally-invasive instruments with hydrodynamic cavitation generating a broad spectrum of sound waves within the degassed fluid inside of the tooth. However, there is not enough evidence in the literature to support its efficacy.
The hypothesis of this study is that the GentleWave (GW) hydrodynamic cavitation system (Sonendo, Inc., Laguna Hills, CA) will achieve a high success rate in treating and healing apical periodontitis (AP), a disease where a bacterial film is formed on the tissues around the teeth.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: