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NCT05555043 · ClinicalTrials.gov registry record · NA
Comparison of Clinical Outcomes Between GentleWave® and Biolase®
A NA study of Endodontic Disease and Periapical Diseases, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05555043: Completed NA study of Endodontic Disease and Periapical Diseases, sponsored by University of North Carolina, Chapel Hill.
NCT05555043 is a NA study of Endodontic Disease and Periapical Diseases that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 120 participants, roughly in line with the 125-participant average among 3 other Endodontic Disease trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05555043, a NA study of Endodontic Disease and Periapical Diseases, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
A combination of the clinical findings and Periapical Index Scores (PAI) score will be used to determine the primary outcome measure as healed, healing, or diseased as per the following descriptions: (i) Healed: Clinical normalcy other than tenderness to percussion accompanied by PAI scores of 1 or 2 (ii) Healing: Clinical normalcy other than tenderness to percussion accompanied by a reduction in the size of the periradicular lesion denoted by a reduction in the PAI score (iii) Diseased: The pr
Conditions Studied
Interventions
- DEVICE Irrisafe ip
- DEVICE GentleWave System
- DEVICE Waterlase iPlus
Study Locations (1)
North Carolina
- Univeristy of North Carolina Adams School of Dentistry - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2025-07-25 |
| Phase | NA |
What the finished NCT05555043 record still lists
NCT05555043 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 125-participant average among 3 other Endodontic Disease trials with a reported enrollment target.
The record links to 4 conditions, with Endodontic Disease appearing as the primary indexed condition, and to 3 interventions - of which Irrisafe ip is the first listed.
NCT05555043 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05555043 about?
NCT05555043 is a clinical study titled "Comparison of Clinical Outcomes Between GentleWave® and Biolase®". 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 t...
What is the current status of trial NCT05555043?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2022-11-08. Estimated completion is 2025-07-25.
What conditions does trial NCT05555043 study?
This clinical trial studies the following conditions: Endodontic Disease, Periapical Diseases, Periapical Periodontitis, Root Canal Infection.
What interventions are being tested in trial NCT05555043?
The interventions under investigation include: Irrisafe ip (DEVICE), GentleWave System (DEVICE), Waterlase iPlus (DEVICE).
Who is sponsoring clinical trial NCT05555043?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05555043 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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