Root CanalTo The PointNCT02478723
A Study Evaluating the Sonendo GentleWave™ System
An observational study of Root Canal, run by Sonendo, Inc. at 1 site in United States.
Trial summary
A post market, observational study evaluating the treatment of 1st and 2nd molars indicated for root canal therapy and treated with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Root Canal
- What is being tested?
- Sonendo GentleWave™ System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 27 Mar 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years of age or older, who have a 1st or 2nd molar tooth that received root canal therapy with the Sonendo GentleWave System and obturation with CPoint and BC Sealer in at least one canal.
Who may be able to join
- The patient is 18 years of age or older
- The subject tooth has been treated for root canal therapy with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal
- The subject tooth is a 1st or 2nd molar
Who cannot join
- Vertical fracture, horizontal fracture, or perforation extending below the Cemento-Enamel Junction (CEJ) of the subject tooth
- Subject tooth having previous or attempted pulpectomy or root canal therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study Evaluating the Sonendo GentleWave™ System and the EndoTechnologies CPoint™ Obturation for Treatment of Molar Teeth Requiring Root Canal Therapy
A post market, observational study evaluating the treatment of 1st and 2nd molars indicated for root canal therapy and treated with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal.
- Conditions
- Root Canal
- Being tested
- Sonendo GentleWave™ System
- Keywords
- requiring therapy, Teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonendo GentleWave™ SystemDevice
Also called EndoTechnologies CPoint™ Obturation
The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject teeth that are healed or are healing at the twenty-four month follow-up visit.
Healed is defined by absence of a radiographic indication of apical periodontitis (Periapical Index Score < 3) and absence of clinical signs and symptoms.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startApr 2015
- Primary completion24 Jan 2018
- Study completion27 Mar 2019
Why it stopped: Study device no longer manufactured by Sonendo. Total enrollment for the study was 20 subjects, only 3 subjects were enrolled and treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root CanalStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonendo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Miller, Study director, Sonendo, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478723
- Sponsor's protocol ID
- CS-08
- Acronym
- To The Point
- Status last verified
- Mar 2019
- First submitted
- 17 Jun 2015
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Evaluating the Sonendo GentleWave™ System and the EndoTechnologies CPoint™ Obturation for Treatment of Molar Teeth Requiring Root Canal Therapy
- ClinicalTrials.gov ID
- NCT02478723
- Acronym / sponsor ID
- To The Point / CS-08
- Conditions
- Root Canal
- Keywords
- requiring therapy, Teeth
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study device no longer manufactured by Sonendo. Total enrollment for the study was 20 subjects, only 3 subjects were enrolled and treated.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sonendo, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 23 Jun 2015 (estimated)
- 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.
A post market, observational study evaluating the treatment of 1st and 2nd molars indicated for root canal therapy and treated with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or older, who have a 1st or 2nd molar tooth that received root canal therapy with the Sonendo GentleWave System and obturation with CPoint and BC Sealer in at least one canal.
Key inclusion criteria (3 listed)
- The patient is 18 years of age or older
- The subject tooth has been treated for root canal therapy with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal
- The subject tooth is a 1st or 2nd molar
Key exclusion criteria (2 listed)
- Vertical fracture, horizontal fracture, or perforation extending below the Cemento-Enamel Junction (CEJ) of the subject tooth
- Subject tooth having previous or attempted pulpectomy or root canal therapy
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 |
|---|---|---|
| Sonendo GentleWave™ SystemAlso: EndoTechnologies CPoint™ ObturationThe Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy. | Device | – |
Primary outcome
Subject teeth that are healed or are healing at the twenty-four month follow-up visit.
Time frame: 24 months
Healed is defined by absence of a radiographic indication of apical periodontitis (Periapical Index Score < 3) and absence of clinical signs and symptoms.
Results and safety
The study was stopped early (reason given: Study device no longer manufactured by Sonendo. Total enrollment for the study was 20 subjects, only 3 subjects were enrolled and treated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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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.
Dan Miller study director
Sonendo, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Root Canal, run by Sonendo, Inc. 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 3 inclusion and 2 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 4 Apr 2019. 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: Study device no longer manufactured by Sonendo. Total enrollment for the study was 20 subjects, only 3 subjects were enrolled and treated.). 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?
Subject teeth that are healed or are healing at the twenty-four month follow-up visit. (time frame: 24 months). 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 4 Apr 2019.