Clinical Efficacy of the GentleWave® System Compared to Conventional Irrigation Techniques: A Systematic Review

Effective root canal disinfection depends on irrigation, but newer technologies require careful clinical evaluation.The GentleWave® system (Sonendo Inc., Laguna Hills, USA) uses multisonic energy and fluid dynamics and has been proposed to improve debridement while limiting canal enlargement.This systematic review evaluated GentleWave-assisted root canal treatment for postoperative pain, clinical and radiographic healing, and clinically reported disinfection outcomes.The review was registered in PROSPERO (CRD420250648962) and conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020.PubMed/MEDLINE, Embase, Scopus, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, and EBSCOhost databases were searched from inception to October 21, 2025.Human clinical studies reporting at least one prespecified outcome were eligible.Owing to clinical and methodological heterogeneity, findings were synthesized descriptively.Five publications were included: two randomized controlled trials and three reports from prospective noncomparative cohorts.A pooled participant total was not calculated because two publications represented different follow-up periods from the same cohort and further overlap could not be excluded.Postoperative pain was frequently reported early in the randomized trials, but mean intensity was generally low to mild and decreased over time.Neither trial demonstrated a statistically significant between-group difference during the first postoperative week.The noncomparative publications reported combined clinical and radiographic healing proportions exceeding 97% at six to 12 months.No eligible study directly evaluated intracanal disinfection clinically.Low-certainty randomized evidence therefore did not demonstrate a clear short-term pain advantage of GentleWave over conventional syringe irrigation with ultrasonic activation.The high healing proportions were derived from noncomparative, potentially overlapping evidence of very low certainty.Adequately powered comparative studies with longer follow-up are needed.