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

August 18, 2025 updated by: University of Iowa
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa College of Dentistry and Dental Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sonendo GentleWave
Every participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System.
Device: GentleWave System
The GentleWave hydrodynamic cavitation system is a 510k FDA-approved multisonic energy system that is used in complex root canal procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Cone Beam Computed Tomography Periapical Index (CBCTPAI) across 1 year
Time Frame: Baseline; 6-months; 12 months
This will be assessed by the evaluator measuring the estimated tooth on the CBCT and assigning an index score on the CBCT. A score of 0 denotes an intact periapical bone structure. A score of 1 denotes a diameter of periapical radiolucency >0.5-1mm. A score of 2 denotes a diameter of periapical radiolucency >1-2mm. A score of 3 denotes a diameter of periapical radiolucency >2-4mm. A score of 4 denotes a diameter of periapical radiolucency >4-8mm. A score of 5 denotes a diameter of periapical radiolucency >8mm. A score of 6 denotes (n) + E = expansion of periapical cortical bone. A score of 7 denotes (n) + D = destruction of periapical cortical bone.
Baseline; 6-months; 12 months
Change from baseline of peripical index (PAI) across 1 year.
Time Frame: Baseline; 6-months post-baseline; 12 months post-baseline
This will be assessed by asking the evaluator to evaluate the PAI score at each X-ray. A value of 1 denotes normal periapical structures. A value of 2 denotes small changes in the bone structure. A value of 3 denotes changes in bone structure with some mineral loss. A value of 4 denotes apical periodontitis with well-defined radiolucent areas. A value of 5 denotes severe apical periodontitis with exacerbating features.
Baseline; 6-months post-baseline; 12 months post-baseline
Change from baseline of modified wound healing scale (Mod-CWHS) across 1 year
Time Frame: 6 months post-baseline; 12 months post-baseline
This will be assessed by the evaluator evaluating the research subject's healing status on a scale of 1-3. A value of 1 is "Uneventful wound healing with no gingival edema, erythema, suppuration, discomfort or barrier exposure. A value of 2 is "Uneventful wound healing with slight gingival edema, erythema, or discomfort but no suppuration. 3 is a value of poor wound healing with significant gingival edema, erythema, discomfort, loss of barrier or any suppuration.
6 months post-baseline; 12 months post-baseline
Change from baseline of pain severity in 0-10 pain severity scale across 1 year
Time Frame: Baseline; 2 days post-baseline; 1 weeks post-baseline; 2 weeks post-baseline; 6 months post-baseline; 12-months post-baseline
This will be assessed by asking the research subject their current level of pain on a 0-10 scale, and the patient will circle one line.
Baseline; 2 days post-baseline; 1 weeks post-baseline; 2 weeks post-baseline; 6 months post-baseline; 12-months post-baseline
Change from Day 2 of research subject's thoughts on treatment result across 1 year.
Time Frame: 2 days post-baseline; 1-week post-baseline; 2-weeks post-baseline; 6-months post-baseline; 12 months post-baseline
This will be assessed by asking the research subject to assess their own treatment result on a scale of 0 to 10 and circling one line.
2 days post-baseline; 1-week post-baseline; 2-weeks post-baseline; 6-months post-baseline; 12 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

  • Principal Investigator: Fabricio Teixeira, DDS,MS,PhD, University of Iowa College of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202102255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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