Abstract
Aim The objectives of this scoping review are to map the evidence available in the literature on using the GentleWave System (GWS) in endodontic treatments and to identify knowledge gaps.
Methods Searches were conducted in PubMed, Scopus and Web of Science. We included randomized and non-randomized clinical trials, cohort studies, case series and cross-sectional studies that evaluated or reported using the GWS. In vitro studies assessing the GWS versus a control group were included. Studies were independently selected by two researchers based on eligibility criteria. Two reviewers each extracted data from half of the included studies. The following data were extracted: study design, purpose, number of study groups, sample size and sample type, analyzed outcome, outcome measurement and main results. A descriptive analysis of the data was performed.
Results Twenty-seven studies were included. In vitro studies were the most frequent study design (85.2%). Of these studies, 13 evaluated root canal disinfection. The general results demonstrated that the GWS produces results superior to the observed comparison groups. Only four studies were conducted in humans (13.8%): three prospective clinical studies and one randomized clinical trial. However, the results of these studies seem to demonstrate that the GWS is a promising treatment.
Conclusion Available evidence demonstrates that knowledge about GWS is still very limited. Although most of the studies in our review demonstrated that the GWS performed better than or similar to other observed systems, caution should be exercised regarding its clinical recommendation, as evidence of its superiority comes only from in vitro studies.
Keywords
Endodontics; Review; Root canal preparation; Root canal therapy
Introduction
Endodontic diseases often result from the evolution of dental caries and are the main reasons for seeking dental care1-4. Eliminating necrotic tissue and bacteria is a crucial step of endodontic therapy and provides a better chance of achieving success and obtaining a favorable treatment prognosis5.
The chemical–mechanical preparation is a step of endodontic treatment and aims to disinfect the root canal system6,7. For this procedure, it is necessary to shape the root canal system with either manual or mechanized instruments and to use sonic and ultrasonic devices associated with irrigation solutions. These solutions aim to improve the removal of microorganisms from root canal systems5. Auxiliary solutions are used as decalcifying substances to remove the smear layer and open and expose the dentinal tubules for penetration of irrigants and intracanal medication8,9.
However, even after adequate chemical–mechanical preparation, current techniques and instruments still cannot ensure that canals are free of bacteria10. The permanence of microorganisms can result from several factors and anatomical complexities, such as curvatures, isthmuses and anastomoses, lateral canals, apical ramifications and canals of different formats, considered challenging to access by endodontic instruments11. Cases with these complexities depend mainly on the effects of irrigating solutions and intracanal medications for complete cleaning and disinfection12.
Recently, a new device known as the GentleWave System (GWS) (Sonendo, Laguna Hills, CA, USA) was developed to clean root canals. The system works through a handpiece positioned on the occlusal surface of the already accessed tooth, and it is activated from a computer console. In addition, the system contains a technology called multisonic ultra-cleaning, which is based on the energy generated by various wavelengths of sound over a wide frequency range. The irrigant solutions and chelating agents (3% sodium hypochlorite, distilled water and 8% ethylenediamine tetraacetic acid—EDTA) are associated with the sonic movement. The machine alternates the flow of irrigation fluid, which interacts with the stationary liquid inside the pulp chamber, creating a shear force that causes hydrodynamic cavitation, forming microbubbles13.
The GWS features a built-in suction that removes fluid and residual debris through a negative pressure created inside the root canal system, promoting crown–apex cleaning10,14. Furthermore, according to the manufacturer, the canals can be treated with minimal instrumentation and do not need to be enlarged beyond the ISO 15 size, thus preserving the tooth structure14,15.
Although some articles have been published over the last several years discussing the use of the GWS system, its introduction to the market is still very recent, and a better understanding of it is still necessary. In addition, no systematic literature search has been performed to map the available evidence and identify knowledge gaps. Therefore, a scoping review is an appropriate method since it is designed to map and evaluate characteristics and evidence of a given subject based on broad research questions16. Thus, this study aimed to conduct a scoping review to map the available evidence on the use of the GWS and identify gaps in knowledge to guide future research on this technology.
Materials and Methods
The design of this study was based on the recommendations of Peters et al.16 (2020). The study protocol is available on the Open Science Framework platform through the https://osf.io/n5vhb/ link, and the reporting of the study is based on the PRISMA-ScR17.
Eligibility criteria
Concept
The concept of interest was human and in vitro studies using the GWS, regardless of the outcome.
Context
For human studies, no restrictions were applied regarding the patient’s age, study setting, endodontic technique used or outcome measured. For in vitro studies, no restrictions were applied regarding the laboratory analysis performed. Additionally, we included studies published in English, Spanish and Portuguese since 2014, the year the technology was developed.
Types of participants
The included human studies involved patients of any age who underwent endodontic treatment, regardless of the reason for treatment, tooth group, preparation technique and filling technique. It was only necessary that the GWS was used during the treatment.
For in vitro studies, any dental group was considered, regardless of the preparation and filling technique used, and it was only necessary that the GWS was used during treatment and had a comparator group.
Types of sources of evidence
Randomized and non-randomized clinical trials, retrospective and prospective cohort studies, case series and cross-sectional studies that evaluated or reported the use of the GWS were included. Furthermore, any in vitro study assessing the use of GWS versus a control group, regardless of the purpose of the study or the analysis performed, was included.
Search
Searches were performed in electronic databases (PubMed, Scopus and Web of Science) restricted from January 1, 2014 (year of technology development), to September 1, 2022. The search strategy was developed based on terms of the PubMed MeSH and adapted to the other databases (Table 1). References of included studies were analyzed to identify additional studies.
Screening
The studies were selected using the Rayyan web platform (https://www.rayyan.ai/), where duplicate studies were removed. Initially, a pilot test was conducted to test the agreement in the selection of studies between the two reviewers (DJL and MCP) involved in this phase. The references were randomly selected using the Excel program (Microsoft Corporation, Redmond, WA, USA). Then, the two researchers independently evaluated the articles, first analyzing the titles and abstracts for the presence of the eligibility criteria. These articles were classified as “include,” “exclude,” or “undefined.” Then, the evaluation of the full texts of the articles classified as “include” and “undefined” was conducted independently by the same two reviewers. Discrepancies in selecting titles/abstracts and full texts were resolved through discussion. In case of disagreement, the opinion of a third reviewer (RSO) was obtained.
Data collection
A standardized data extraction form was created using Excel. First, 10% of the included studies were randomly selected in Excel to test the data extraction process and ensure consistency in interpreting the items. Next, the pilot test was conducted through discussion between the reviewers involved in this study phase. Subsequently, two reviewers (DJL and MCP) each extracted data from half of the included studies, and a third reviewer (RSO) checked the consistency of the data.
The following data were extracted: study design, purpose of the study, analyzed outcome, how the outcome was measured and main results. The number of study groups, sample size and sample used (e.g., assessed dental group—molar, printed root canals) were also collected.
Data analysis
Analyses were conducted in Excel. Descriptive data analysis was performed, considering the study design separately. Data were summarized in tables and figures.
Results
The search resulted in the identification of 177 studies. Forty-eight duplicates were removed, resulting in 129 articles. After analyzing the titles and abstracts, 102 articles were removed. Twenty-seven studies were assessed for eligibility through their full texts, and two articles were excluded (see Supplementary Material). After analyzing references from other studies, two additional articles were included. Thus, 27 studies were included in this scoping review. Figure 1 presents a flowchart depicting study selection. Twenty-three (85.2%) studies were classified as in vitro and four (14.8%) as human studies.
Table 2 presents the characteristics of in vitro studies. The sample size ranged from one to 900, and only one study evaluated 900 models of 3D-printed root canals; the majority (64.0%) of studies used molar teeth. Thirteen studies (56.5%) tested canal disinfection and measured different outcomes and used different verification methods. Most of these studies demonstrated that the GWS was superior to the systems used for comparison10,18-23. In four studies, there was no difference between the GWS and the compared groups24-27, and, in two studies, the GWS was shown to be inferior8,28.
Three articles evaluated the effectiveness of removing filling material (gutta-percha, cement and calcium hydroxide29-31), and, in only one study, the GWS failed to remove the filling material completely31. Even the first published study on the GWS, which evaluated its effectiveness at tissue dissolution, demonstrated that the system dissolved tissues at a significantly faster rate than conventional irrigation devices32.
Several studies evaluated other outcomes. Wang et al.33 (2016) demonstrated that the GWS caused minimal erosion in root dentin, as did the NaOCl group, followed by final irrigation with EDTA. In another study, the anatomy of the dentin of the root canal wall was examined using scanning electron microscopy, and a wide variety of structures, especially in the middle and apical regions, were observed to have no remnants of organic tissue or dentin34.
One study found that the GWS and Endovac irrigations were not associated with apical extrusion14. Three other studies evaluated apical pressure while using the GWS and employed the same analysis method. Ordinola-Zapata et al.35(2021) reported that the GWS produced negative pressure, and closed needles generated lower apical pressure than open needles. According to Chen et al.36(2021), a larger apical size did not result in higher apical pressure than smaller sizes for needle irrigation, and the GWS and negative pressure during irrigation contributed to improved safety compared to positive pressure. This result corroborates a study by Haapasalo et al.37 (2016), in which the GWS was shown to create negative pressure in the apical foramen during root canal cleaning, regardless of the size of the canal instrumentation.
Table 3 presents the characteristics and results of the human studies included. Three were classified as prospective clinical studies, and one was a randomized clinical trial. These studies had sample sizes between 36 and 77. Three studies evaluated molar teeth, and only one article considered premolars. Three articles evaluated the success rate based on signs, symptoms and radiographic evaluations. Of these, two articles considered the same sample but used different follow-up times: 6 and 12 months. The GWS had a healing success rate of 97.4% after 6 months38 and 97.3% after 12 months39. In the other study, treatment with the GWS considerably reduced periapical lesions, with a success rate of 97.7% at the 12-month reassessment13.
Of all included studies, only one was a randomized clinical trial40. The study compared the use of the GWS to endodontic treatment with conventional irrigation and evaluated the incidence and intensity of postoperative pain using a pain scale. The study found no significant difference in the incidence or intensity of pain with the two methods. However, patients on both evaluated systems that were evaluated reported a significant decrease in pain within 6 hours of treatment.
Discussion
This study is the first to use a complete knowledge synthesis method to improve understanding of the available evidence on using the GWS. The main result was that the evidence regarding the use of this technology is still limited, since most of the included studies were in vitro, and there were only four clinical studies of the GWS. However, some aspects should be highlighted: 1) most in vitro studies demonstrated the superiority of GWS compared to other methods, mainly for cleaning and disinfection of the root canal10,18-23; 2) a significant portion of the remaining in vitro studies and the only randomized clinical trial included in this scoping review revealed similar results between the GWS and its comparators14,24-27,31,33,36,40; and 3) most of the clinical studies included did not establish a control group, which hinders a clear understanding of the GWS.
In vitro studies are performed to simulate biological conditions in the laboratory, providing researchers with information useful for the development of further studies. These studies have been widely used to test new materials and therapeutic or preventive procedures within the field of dentistry, especially in endodontics41. However, in vitro studies have some limitations, such as the difficulty of extrapolating results to human beings42. Despite the caution needed when interpreting in vitro studies, the available evidence seems to demonstrate that the GWS is a promising treatment. However, it is important to note that the GWS works through a handpiece positioned on the occlusal surface of the already accessed tooth. This condition requires the system to reach the occlusal position, which is problematic if the patient has restricted mouth opening capability and is probably difficult to simulate in in vitro studies. Regardless, in vitro studies are performed to assess the reduction of bacterial DNA and the dissolution of organic matter, although it is impossible for them to reproduce a clinical scenario and its associated challenges.
Only four clinical studies were identified in this review. Only one was a randomized clinical trial40, which is considered the ideal study design for testing health interventions43, and the other three were prospective clinical studies13,38,39. Grigsby et al.40 (2020) showed no significant difference in the incidence or intensity of pain after using irrigant solutions with the GWS versus conventional irrigation. The other three clinical studies did not include a control group13,38,39, which makes it impossible to compare the results produced using the GWS with those produced with other instrumentation systems. This fact corroborates the conclusion that the evaluation of the GWS is still in the very early stages.
Recently, a narrative review describing the results of the GWS in endodontic treatment was published. In general, the results demonstrated that the GWS promoted the reduction of bacterial DNA, faster dissolution of organic matter and greater penetration of sodium hypochlorite into dentinal tubules44. However, narrative reviews do not use explicit and systematic criteria for the search and critical analysis of the literature, making it difficult for other researchers to reproduce their results. Searching for sources does not involve the application of a predetermined and specific strategy and is often less comprehensive. Furthermore, the selection of studies and interpretation of information may be influenced by the subjectivity of the authors and selection bias45. The present study performed a scoping review, which mapped the main concepts of the GWS. A scoping review examines the extent, scope and nature of investigations, summarizes and disseminates the investigation data systematically, reproducibly and transparently and identifies gaps in existing research46.
It is essential to note that the GWS is expensive, reaching up to 70,000 USD47, and this may make the development of clinical studies unfeasible, especially because they are already considered more expensive than other types of studies. However, the success rate of the GWS seems to be similar to that of other root canal instrumentation systems, which may not justify the use of this technology and the development of new studies. Thus, analyses that consider the cost-effectiveness of the GWS are still necessary for a better understanding of the viability of its use. Maybe the cost of the GWS explains why only four studies used the GWS in patients. In addition, it is necessary to train personnel to use the system since dentistry schools teach only the conventional methods for endodontic treatment. As a result, few professionals can apply this new technology.
This study has some important limitations. First, a search in the gray literature was not conducted because it was understood that the technology is still in the very early stages; therefore, articles on the subject were expected to be indexed in the searched databases. Second, data extraction was not performed in duplicate, but prior training of the researchers was performed to reduce possible errors.
Knowledge about mechanized systems to aid chemical–mechanical preparation contributes to the success of endodontic therapy. This process is essential for biofilm removal and root canal disinfection. In the future, more randomized clinical trials should be performed to compare the GWS with two or more root canal cleaning systems, and they should consider cost-effectiveness analyses during study development. Furthermore, clinical studies already published on the subject must continue their follow-ups to obtain long-term evidence.
In conclusion, the evidence available on the GWS is mostly based on in vitro studies and four clinical studies and demonstrates that knowledge about using the technology is still very limited. Caution should be exercised regarding the clinical recommendation of the GWS, as evidence of its superiority comes only from in vitro studies, and there is still no evaluation of its cost-effectiveness, which seems essential due to its high cost compared to other systems available on the market.
Funding Statement and Acknowledgments
MCP is funded by the ATITUS Education and Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES). RSO is funded in part by Meridional Foundation (Passo Fundo, Brazil). The funders had no role in the study design, data collection and analysis, or manuscript publication.
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47 Atlas Resell Management. Garden City, Idaho, USA; 2023. [cited 2023 Feb 28]. Available from: https://atlasresell.com/blogs/news/sonendo-gentlewave-the-new-wave-of-endodontics-technology-and-safety-1
» https://atlasresell.com/blogs/news/sonendo-gentlewave-the-new-wave-of-endodontics-technology-and-safety-1
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Data Sharing:
Data, analytical code, or other materials will be shared upon request.
Edited by
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Editor:
Dr. Altair A. Del Bel Cury
Data availability
Data, analytical code, or other materials will be shared upon request.
Publication Dates
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Publication in this collection
11 Apr 2025 -
Date of issue
2025
History
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Received
09 Aug 2023 -
Accepted
19 Nov 2024


