Root Canal TreatmentNCT04105907
Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection of Difficult to Reach Areas in Mandibular Human Molars II. An In-vivo Study.
A study testing GentleWave in people with Root Canal Treatment, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Root Canal Treatment
- What is being tested?
- GentleWave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only teeth that patient decided to have the extraction done instead of having any other type of dental treatment and teeth extracted at patient's petition.
Who cannot join
- Teeth with root fractures or previously root canal treated teeth.
- Teeth with severe loss of structure
- Children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
David E Jaramillo, DDS, 713-486-4224, David.E.Jaramillo@uth.tmc.edu
Auco Dang, (713) 486-4258, Auco.Dang@uth.tmc.edu
About this study
The purpose of this study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo
- Conditions
- Root Canal Treatment
- Being tested
- GentleWave
- Keywords
- GentleWave, Multisonication, Sonendo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleWaveDevice
Subject teeth will receive a partial root canal treatment with the Sonendo GentleWave system followed by extraction of the tooth and histological evaluation of the tooth
| Study group | Role | What they receive |
|---|---|---|
| Partial root canal treatment with the Sonendo GentleWave | Experimental | Not described Receives: Device: GentleWave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of the amount of pulp tissue left behind after GentleWave procedure
Visualization of the amount of pulp tissue left behind after GentleWave procedure as assessed by reviewing the histological serial sections under the light microscope
Measured: at the time of tooth extraction(immediately after GentleWave procedure)
Secondary outcomes (1)
Number of participants with the presence of bacteria inside the root canal and inside the dentinal tubules as assessed by observation under the light microscope
Measured: at the time of tooth extraction(immediately after GentleWave procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Sonendo, Inc.
- Responsible party
- Principal investigator, David E Jaramillo, The University of Texas Health Science Center, Houston
- Investigators
- David E Jaramillo, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105907
- Sponsor's protocol ID
- HSC-DB-19-0476
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection of Difficult to Reach Areas in Mandibular Human Molars II. An In-vivo Study.
- ClinicalTrials.gov ID
- NCT04105907
- Acronym / sponsor ID
- HSC-DB-19-0476
- Conditions
- Root Canal Treatment
- Keywords
- GentleWave, Multisonication, Sonendo
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Sonendo, Inc.
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 26 Sep 2019 (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 study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial root canal treatment with the Sonendo GentleWave | Experimental | Device: GentleWave |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only teeth that patient decided to have the extraction done instead of having any other type of dental treatment and teeth extracted at patient's petition.
Key exclusion criteria (3 listed)
- Teeth with root fractures or previously root canal treated teeth.
- Teeth with severe loss of structure
- Children
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 |
|---|---|---|
| GentleWaveSubject teeth will receive a partial root canal treatment with the Sonendo GentleWave system followed by extraction of the tooth and histological evaluation of the tooth | Device | Partial root canal treatment with the Sonendo GentleWave |
Primary outcome
Visualization of the amount of pulp tissue left behind after GentleWave procedure
Time frame: at the time of tooth extraction(immediately after GentleWave procedure)
Visualization of the amount of pulp tissue left behind after GentleWave procedure as assessed by reviewing the histological serial sections under the light microscope
1 secondary outcome
Number of participants with the presence of bacteria inside the root canal and inside the dentinal tubules as assessed by observation under the light microscope
Time frame: at the time of tooth extraction(immediately after GentleWave procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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.
David E Jaramillo, DDS principal investigator
The University of Texas Health Science Center, Houston
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 in people with Root Canal Treatment, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David E Jaramillo, DDS (713-486-4221, David.E.Jaramillo@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of the amount of pulp tissue left behind after GentleWave procedure (time frame: at the time of tooth extraction(immediately after GentleWave procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.