Abstract
BackgroundThis prospective multi-center (PURE) clinical study evaluated healing rates for molars after root canal treatment employing the GentleWave® System (Sonendo, Inc., Laguna Hills, CA).Material and MethodsEighty-nine patients met the inclusion criteria and consented for this clinical study after referral for a root canal treatment. All enrolled patients were treated with the GentleWave System. Five endodontists performed the clinical procedures and follow-up evaluations. Pre-operative, intra-operative, and post-operative 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 tooth radiographs for apical periodontitis using the periapical index (PAI). The teeth classified as healing or healed were considered as a success and composed of a cumulative success rate of healing. Statistical analysis was performed by using the Fisher’s exact test, Pearson correlation, and multivariate logistic regression analyses of the pre-operative prognostic factors at 0.05 significance level.ResultsSeventy-seven patients were evaluated at six months with a follow-up rate of 86.5%. The cumulative success rate of healing was 97.4%. Eleven prognostic factors were identified using bivariate analyses. Using logistic analyses, the two prognostic significant variables that were directly correlated to healing were the pre-operative presence of periapical index (p value=0.016), and single treatment visits (p value=0.024).ConclusionsIn this six-month PURE clinical study, the cumulative success rate of healing was 97.4% when patients were treated with the GentleWave® System. Key words:Healing rate, root canal treatment, molar, GentleWave™, Sonendo®, Multisonic Ultracleaning™ .
Highlights
Endodontic treatment aims to remove vital and/or necrotic tissue, bacteria and bacterial irritants from the root canal system, thereby promotes healing of the periapical area [1,2]
Different irrigation techniques and devices have been developed to improve the cleaning of the root canal system, including ultrasonic irrigation, negative pressure irrigation, sonic irrigation, photo-induced photo-acoustic streaming (PIPS), and laser technologies
Tissue debris and biofilm cleaning of even contemporary techniques is often insufficient to provide an environment conducive for long term success [2,9,10,11]. Most of these techniques require increased dentin removal from the roots to facilitate the penetration of irrigants into the root canal system, which may weaken the remaining tooth and thereby negatively affect long-term healing rates [12,13]
Summary
Endodontic treatment aims to remove vital and/or necrotic tissue, bacteria and bacterial irritants from the root canal system, thereby promotes healing of the periapical area [1,2]. Complete root canal cleaning and disinfection is essential to achieve healing of periradicular tissue and successful endodontic treatment [3]. Tissue debris and biofilm cleaning of even contemporary techniques is often insufficient to provide an environment conducive for long term success [2,9,10,11] Most of these techniques require increased dentin removal from the roots to facilitate the penetration of irrigants into the root canal system, which may weaken the remaining tooth and thereby negatively affect long-term healing rates [12,13]. The GentleWave System was the only technique that removed all the calcium hydroxide even in the apical thirds These studies were performed in-vitro using extracted teeth.
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