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



      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).


      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 #20/.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.


      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).


      In this 12-month prospective multicenter clinical study, the GentleWave System showed a high level of success after a 12-month follow-up.

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        • Sjogren U.
        • Hagglund B.
        • Sundqvist G.
        • Wing K.
        Factors affecting the long-term results of endodontic treatment.
        J Endod. 1990; 16: 498-504
        • Ng Y.L.
        • Mann V.
        • Rahbaran S.
        • et al.
        Outcome of primary root canal treatment: systematic review of the literature—part 1. Effects of study characteristics on probability of success.
        Int Endod J. 2007; 40: 921-939
        • Nair P.N.
        Pathogenesis of apical periodontitis and the causes of endodontic failures.
        Crit Rev Oral Biol Med. 2004; 15: 348-381
        • Siqueira J.F.
        Aetiology of root canal treatment failure: why well-treated teeth can fail.
        Int Endod J. 2001; 34: 1-10
        • Baumgartner J.C.
        • Mader C.L.
        A scanning electron microscopic evaluation of four root canal irrigation systems.
        J Endod. 1987; 13: 147-157
        • Haapasalo M.
        • Endal U.
        • Zandi H.
        • Coil J.M.
        Eradication of endodontic infection by instrumentation and irrigation solutions.
        Endod Topics. 2005; 10: 77-102
        • Tay F.R.
        • Gu L.
        • Schoeffel G.J.
        • et al.
        Effect of vapor lock on root canal debridement by using a side-vented needle for positive-pressure irrigant delivery.
        J Endod. 2010; 36: 745-750
        • Munoz H.R.
        • Camacho-Cuadra K.
        In vivo efficacy of three different endodontic irrigation systems for irrigant delivery to working length of mesial canals of mandibular molars.
        J Endod. 2012; 38: 445-488
        • Beus C.
        • Safavi K.
        • Stratton J.
        • Kaufman B.
        Comparison of the effect of two endodontic irrigation protocols on the elimination of bacteria from root canal system: a prospective, randomized clinical trial.
        J Endod. 2012; 38: 1479-1483
        • Yost R.A.
        • Bergeron B.E.
        • Kirkpatrick T.C.
        • et al.
        The EndoVac and EndoActivator groups produced significantly less extrusion than PIPS irrigation.
        J Endod. 2015; 4: 1530-1534
        • Saini H.R.
        • Tewari S.
        • Sangwan P.
        • et al.
        Effect of different apical preparation sizes on outcome of primary endodontic treatment: a randomized controlled trial.
        J Endod. 2012; 38: 1309-1315
        • Haapasalo M.
        • Wang Z.
        • Shen Y.
        • et al.
        Tissue dissolution by a novel multisonic ultracleaning system and sodium hypochlorite.
        J Endod. 2014; 40: 1178-1181
        • Ma J.
        • Shen Y.
        • Yang Y.
        • et al.
        In vitro study of calcium hydroxide removal from mandibular molar root canals using a GentleWave System.
        J Endod. 2015; 41: 553-558
        • Charara K.
        • Friedman S.
        • Sherman A.
        • et al.
        Assessment of apical extrusion during root canal procedure with the novel GentleWave System in a simulated apical environment.
        J Endod. 2016; 42: 135-139
        • Molina B.
        • Glickman G.N.
        • Vandrangi P.
        • Khakpour M.
        Histological evaluation of root canal debridement of human molars using the GentleWave System.
        J Endod. 2015; 41: 1701-1705
        • Wohlgemuth P.
        • Cuocolo D.
        • Vandrangi P.
        • Sigurdsson A.
        Effectiveness of the GentleWave System in removing separated instruments.
        J Endod. 2015; 41: 1895-1898
        • Sigurdsson A.
        • Le K.T.
        • Woo S.M.
        • et al.
        Six-month healing success rates after endodontic treatment using the novel GentleWave System: the PURE prospective multi-center clinical study.
        J Clin Exp Dent. 2016; (in press)
        • Segura-Egea J.J.
        • Cisneros-Cabello R.
        • Llamas-Carreras J.M.
        • Velasco-Ortega E.
        Pain associated with root canal treatment.
        Int Endod J. 2009; 42: 614-620
        • Orstavik D.
        • Kerekes K.
        • Eriksen H.M.
        The periapical index: a scoring system for radiographic assessment of apical periodontitis.
        Endod Dent Traumatol. 1986; 2: 20-34
        • Friedman S.
        • Abitbol S.
        • Lawrence H.P.
        Treatment outcome in endodontics: the Toronto study. Phase 1: initial treatment.
        J Endod. 2003; 29: 787-793
        • Salamat K.
        • Rezai R.F.
        Nonsurgical treatment of extraoral lesions caused by necrotic nonvital tooth.
        Oral Surg Oral Med Oral Pathol. 1986; 61: 618-623
        • Jesslén P.
        • Zetterqvist L.
        • Heimdahl A.
        Long-term results of amalgam versus glass ionomer cement as apical sealant after apicectomy.
        Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995; 79: 101-103
        • Murphy W.K.
        • Kaugars G.E.
        • Collett W.K.
        • Dodds R.N.
        Healing of periapical radiolucencies after nonsurgical endodontic therapy.
        Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1991; 71: 620-624
        • Penesis V.A.
        • Fitzgerald P.I.
        • Fayad M.I.
        • et al.
        Outcome of one-visit and two-visit endodontic treatment of necrotic teeth with apical periodontitis: a randomized controlled trial with one-year evaluation.
        Int Endod J. 2008; 34: 251-257
        • Pettiete M.T.
        • Delano E.O.
        • Trope M.
        Evaluation of success rate of endodontic treatment performed by students with stainless-steel K-Files and nickel-titanium hand files.
        J Endod. 2001; 27: 124-127
        • Gutmann J.L.
        • Saunders W.P.
        • Nguyen L.
        • et al.
        Ultrasonic root-end preparation Part 1. SEM analysis.
        Int Endod J. 1994; 27: 318-324
        • Polycarpou N.
        • Ng Y.L.
        • Canavan D.
        • et al.
        Prevalence of persistent pain after endodontic treatment and factors affecting its occurrence in cases with complete radiographic healing.
        Int Endod J. 2005; 38: 169-178
        • Jurcak J.J.
        • Bellizzi R.
        • Loushine R.J.
        Successful single-visit endodontics during Operation Desert Shield.
        J Endod. 1993; 19: 412-413
        • Oginni A.O.
        • Udoye C.I.
        Endodontic flare-ups: comparison of incidence between single and multiple visit procedures in patients attending a Nigerian teaching hospital.
        BMC Oral Health. 2004; 4: 4
        • Trope M.
        • Delano E.O.
        • Ørstavik D.
        Endodontic treatment of teeth with apical periodontitis: single vs. multivisit treatment.
        J Endod. 1999; 25: 345-350
        • Sathorn C.
        • Parashos P.
        • Messer H.
        The prevalence of postoperative pain and flare-up in single-and multiple-visit endodontic treatment: a systematic review.
        Int Endod J. 2008; 41: 91-99
        • Ng Y.L.
        • Glennon J.P.
        • Setchell D.J.
        • Gulabivala K.
        Prevalence of and factors affecting post-obturation pain in patients undergoing root canal treatment.
        Int Endod J. 2004; 37: 381-391
        • Gondim E.
        • Setzer F.C.
        • Dos Carmo C.B.
        • Kim S.
        Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial.
        J Endod. 2010; 36: 1295-1301
        • Sedgley C.M.
        • Messer H.H.
        Are endodontically treated teeth more brittle?.
        J Endod. 1992; 18: 332-335
        • Murdoch-Kinch C.A.
        • McLean M.E.
        Minimally invasive dentistry.
        J Am Dent Assoc. 2003; 134: 87-95