Comparison of Clinical Outcomes Between GentleWave® and Biolase® (NCT05555043) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Clinical Outcomes Between GentleWave® and Biolase®
United States120 participantsStarted 2022-11-08
Plain-language summary
Introduction: In the US, 15 million root canal treatments (RCTs) are carried out annually. Success rates decrease with conventional chemo-mechanical root canal preparation techniques used on teeth with periapical radiolucencies associated with bacterial presence. New irrigation modalities, such as the GentleWave® System (GWS) and Waterlase iPlus® (WL), have been developed to overcome limitations and improve RCT success rates.
Hypotheses: (1) GWS and WL provide superior clinical outcomes compared to conventional RCT using passive ultrasonic activation (PUI). (2) GWS and WL are acceptable treatment modalities for clinicians and patients.
Aims: (1) Estimate probability of success of GWS, WL, and conventional RCT with PUI. (2) Evaluate clinician and patient experiences of the different techniques.
Who can participate
Age range
14 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients 14 years of age or older (maximum of 99 years of age)
o Participants 14 years of age or older are expected to have permanent teeth erupted in full permanent dentition with close apices
* The subject tooth is indicated for root canal treatment
* One tooth indicated per participant
* Permanent tooth requiring root canal treatment which are deemed restorable
* Teeth exhibiting pulpal pathosis (irreversible pulpitis, pulpal necrosis, previously initiated root canal treatment) and apical periodontitis (with radiographic demonstration of periapical bone loss)
* Patient-signed informed consent/assent form
* Patients display good compliance o Patient is determined cooperative by provider during initial exam and radiographic acquisition
Exclusion Criteria:
* Patients allergic to local or topical anesthetics, heart disease (pacemakers, implantable defibrillators), lung disease, bleeding disorders, immune system deficiency
* Subject tooth is not clinically restorable (prosthetically or periodontally)
* Mobility scores greater than or equal to 2
* Periodontal pocket depths greater than or equal to 6mm
* Cracks with radicular extension, vertical root fracture or horizontal - oblique fracture
* Subject tooth with open or incomplete apices (apical diameter greater than 1mm)
* Subject tooth has insufficient tooth structure to create GWS platform
* Subject tooth has external cervical root resorption
* Subject tooth has signs o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.