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NCT05555043
Comparison of Clinical Outcomes Between GentleWave® and Biolase®
NA trial testing Irrisafe ip in Endodontic Disease in 120 participants. Completed in 25 July 2025.
25 July 2025
Quick facts
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 8 November 2022 |
| Primary completion | 25 July 2025 |
| Estimated completion | 25 July 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Irrisafe ip
- GentleWave System
- Waterlase iPlus
Conditions studied
- Endodontic Disease — all drugs for Endodontic Disease →
- Periapical Diseases — all drugs for Periapical Diseases →
- Periapical Periodontitis — all drugs for Periapical Periodontitis →
- Root Canal Infection — all drugs for Root Canal Infection →
Sponsor
University of North Carolina, Chapel Hill
Who can join
Adults 14 to 99, any sex, with Endodontic Disease or Periapical Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05555043
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Endodontic Disease
Currently open trials in the same condition.
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Other University of North Carolina, Chapel Hill trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05555043 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
- Last refreshed: 12 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05555043.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing