12-month Healing Rates after Endodontic Therapy Using the Novel GentleWave System: A Prospective Multicenter Clinical Study

Introduction: This multicenter, prospective, nonsignificant risk clinical study evaluated healing rates for molars 12 months after endodontic therapy using the GentleWave System (Sonendo, Inc, Laguna Hills, CA). Methods: Eighty-nine patients needing endodontic therapy who met the inclusion criteria consented for this clinical study. All enrolled patients were treated with a standardized protocol consisting of conservative access, shaping of canals to #201.07, GentleWave treatment, and warm vertical obturation. Six endodontists performed the clinical procedures and follow-up evaluations. Preoperative, intraoperative, and postoperative data were collected from the consented patients. Each patient was evaluated for clinical signs and symptoms. Two trained, blinded, and independent evaluators scored the subject's radiographs for signs of apical periodontitis using a periapical index. The teeth classified as healing or healed were considered as a success and accounted for the cumulative success rate of healing. Statistical analysis was performed by using the Fisher exact test, Pearson correlation, and multivariate logistic regression analyses of the preoperative prognostic factors at P = .05. Results: Seventy-five teeth in 75 patients were evaluated at 12 months with a follow-up rate of 84.3%. The cumulative success of endodontic therapy was 97.3%. The success rates of necrotic and irreversible pulpitis were 92.9% and 98.4%, respectively; 3.8% of the patients experienced moderate postoperative pain within 2 days and no incidence of pain at 14 days, 6 months, and 12 months of initial therapy. Ten prognostic factors were identified using bivariate analyses. Using logistic analyses, the prognostic significant variable that was directly correlated to healing was the preoperative presence of lesions (P = .026). Conclusions: In this 12-month prospective multicenter clinical study, the GentleWave System showed a high level of success after a 12-month follow-up.