Apical PeriodontitisNCT04966169
Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study
A study testing GentleWave System in people with Apical Periodontitis, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- GentleWave System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Conditions
- Apical Periodontitis
- Being tested
- GentleWave System
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleWave SystemDevice
The GentleWave hydrodynamic cavitation system is a 510k FDA-approved multisonic energy system that is used in complex root canal procedures.
| Study group | Role | What they receive |
|---|---|---|
| Sonendo GentleWave | Experimental | Every participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System. Receives: Device: GentleWave System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Cone Beam Computed Tomography Periapical Index (CBCTPAI) across 1 year
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.
Measured: Baseline; 6-months; 12 months
Change from baseline of peripical index (PAI) across 1 year.
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.
Measured: Baseline; 6-months post-baseline; 12 months post-baseline
Change from baseline of modified wound healing scale (Mod-CWHS) across 1 year
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.
Measured: 6 months post-baseline; 12 months post-baseline
Change from baseline of pain severity in 0-10 pain severity scale across 1 year
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.
Measured: 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.
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.
Measured: 2 days post-baseline; 1-week post-baseline; 2-weeks post-baseline; 6-months post-baseline; 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start27 Aug 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Why it stopped: PI Departure from the University of Iowa
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabricio Teixeira, DDS,MS,PhD, Principal investigator, University of Iowa College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966169
- Sponsor's protocol ID
- 202102255
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grigsby D Jr, Ordinola-Zapata R, McClanahan SB, Fok A. Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial. J Endod. 2020 Aug;46(8):1017-1022. doi: 10.1016/j.joen.2020.04.004. Epub 2020 Jun 14.
PubMed 32553417Sigurdsson A, Le KT, Woo SM, Rassoulian SA, McLachlan K, Abbassi F, Garland RW. Six-month healing success rates after endodontic treatment using the novel GentleWave System: The pure prospective multi-center clinical study. J Clin Exp Dent. 2016 Jul 1;8(3):e290-8. doi: 10.4317/jced.52779. eCollection 2016 Jul.
PubMed 27398180Sigurdsson A, Garland RW, Le KT, Woo SM. 12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study. J Endod. 2016 Jul;42(7):1040-8. doi: 10.1016/j.joen.2016.04.017.
PubMed 27325455Wohlgemuth P, Cuocolo D, Vandrangi P, Sigurdsson A. Effectiveness of the GentleWave System in Removing Separated Instruments. J Endod. 2015 Nov;41(11):1895-8. doi: 10.1016/j.joen.2015.08.015. Epub 2015 Sep 26.
PubMed 26409807
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of GentleWave on the Healing of Apical Periodontitis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04966169
- Acronym / sponsor ID
- 202102255
- Conditions
- Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Departure from the University of Iowa
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonendo GentleWave | Experimental | Device: GentleWave SystemEvery participant will receive the same experimental treatment, which is root canal therapy using the Sonendo GentleWave System. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GentleWave SystemThe GentleWave hydrodynamic cavitation system is a 510k FDA-approved multisonic energy system that is used in complex root canal procedures. | Device | Sonendo GentleWave |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: PI Departure from the University of Iowa). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 32553417Grigsby D Jr, Ordinola-Zapata R, McClanahan SB, Fok A. Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial. J Endod. 2020 Aug;46(8):1017-1022. doi: 10.1016/j.joen.2020.04.004. Epub 2020 Jun 14.
- Background: PubMed 27398180Sigurdsson A, Le KT, Woo SM, Rassoulian SA, McLachlan K, Abbassi F, Garland RW. Six-month healing success rates after endodontic treatment using the novel GentleWave System: The pure prospective multi-center clinical study. J Clin Exp Dent. 2016 Jul 1;8(3):e290-8. doi: 10.4317/jced.52779. eCollection 2016 Jul.
- Background: PubMed 27325455Sigurdsson A, Garland RW, Le KT, Woo SM. 12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study. J Endod. 2016 Jul;42(7):1040-8. doi: 10.1016/j.joen.2016.04.017.
- Background: PubMed 26409807Wohlgemuth P, Cuocolo D, Vandrangi P, Sigurdsson A. Effectiveness of the GentleWave System in Removing Separated Instruments. J Endod. 2015 Nov;41(11):1895-8. doi: 10.1016/j.joen.2015.08.015. Epub 2015 Sep 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabricio Teixeira, DDS,MS,PhD principal investigator
University of Iowa College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GentleWave System in people with Apical Periodontitis, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI Departure from the University of Iowa). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Cone Beam Computed Tomography Periapical Index (CBCTPAI) across 1 year (time frame: Baseline; 6-months; 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04966169, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.