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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-27

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Apical Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sonendo GentleWave

Every participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System.

Group Type EXPERIMENTAL

GentleWave System

Intervention Type DEVICE

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

Interventions

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GentleWave System

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18+ years
* Speak and Read English
* Able to attend follow-up visits at 6 months AND 1 year (post-baseline treatment)
* A tooth with no response to cold and electric pulp testing.
* Tooth is a 1st or 2nd mandibular molar
* Tooth has no response to cold/electric pulp testing
* Tooth has a diagnosis of pulp necrosis with asymptomatic apical periodontitis
* 1st and 2nd mandibular molars.
* Current (i.e., taken within the last week) radiograph available (or done at screening, as needed)
* A limited-volume, cone-beam computed tomography (CBCT) taken at the first visit confirms apical periodontitis (radiolucency).

Exclusion Criteria

* Patient has advanced untreated periodontal disease/recent periodontal surgery
* Patient has non-odontogenic facial pan (e.g., face pain of unknown cause)
* Patient has a history of poor attendance at dental visits
* Patient is pregnant
* Patient reports taking corticosteroids
* Patient is supervised by the Principal Investigator or a member of the research team
* Patient is subordinate to the Principal Investigator or a member of the research team
* Patient is a student/trainee under the direction of the Principal Investigator or a member of the research team
* Tooth had previous intervention (e.g., pulp debridement: removal of the pulp/nerve of the tooth)
* Tooth has incomplete root formation (e.g., immature with apical periodontitis)
* Tooth has defective restorations or carious lesions (i.e., cavities) that could lead to microleakage
* Tooth has internal or external resorption
* Tooth has a mobility score of 3
* Tooth has a fracture/visibly cracked
* Tooth has vital (i.e., functioning) pulp
* Advanced untreated periodontal disease or recent periodontal surgery.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No