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Endodontic Treatment
GentleWave for Root Canal Treatment
N/A
Recruiting
Led By David E Jaramillo, DDS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of tooth extraction(immediately after gentlewave procedure)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the effectiveness of GentleWave, a new dental cleaning technology, on patients needing tooth cleaning and disinfection. GentleWave uses fluids and sound waves to clean areas inside the tooth more thoroughly than traditional methods. The GentleWave System has been shown to result in a higher tissue dissolution rate and effective cleaning compared to traditional methods.
Who is the study for?
This trial is for adults who have chosen to have a tooth extracted rather than undergo other dental treatments. It's not suitable for teeth with severe structural damage, root fractures, or those that previously had root canal treatment.
What is being tested?
The study is testing the effectiveness of GentleWave technology in cleaning and disinfecting the hard-to-reach areas during a root canal procedure on mandibular molars, using actual human cases.
What are the potential side effects?
Since this trial involves standard dental extraction procedures, potential side effects may include typical post-extraction symptoms such as pain, swelling, bleeding, and infection risk at the site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of tooth extraction(immediately after gentlewave procedure)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of tooth extraction(immediately after gentlewave procedure)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visualization of the amount of pulp tissue left behind after GentleWave procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Partial root canal treatment with the Sonendo GentleWaveExperimental Treatment1 Intervention
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,239 Total Patients Enrolled
Sonendo, Inc.Industry Sponsor
3 Previous Clinical Trials
589 Total Patients Enrolled
2 Trials studying Root Canal
520 Patients Enrolled for Root Canal
David E Jaramillo, DDSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe damage to your teeth.You have teeth with fractures in the roots or that have had root canal treatment before.Participants must be adults and not children.
Research Study Groups:
This trial has the following groups:- Group 1: Partial root canal treatment with the Sonendo GentleWave
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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