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| Title |
The GentleWave Procedure may serve as a useful adjunct to improved healing of periapical lesion |
| Clinical Question |
In patients undergoing nonsurgical root canal treatment, does the use of the GentleWave Procedure as compared to traditional nonsurgical endodontic treatment improve the healing of periapical lesion? |
| Clinical Bottom Line |
The GentleWave Procedure may serve as a useful adjunct to improved healing of periapical lesions. Disinfection of the root canal system is a critical step in nonsurgical endodontic therapy. The GentleWave System was developed as an attempt to improve the cleaning and disinfection of the root canal system while minimizing over-enlargement of the canals. Due to the recent introduction of this device, limited evidence exists regarding the efficacy of this procedure. The strongest evidence available regarding the healing of periapical lesions using the GentleWave System is a prospective clinical study. Success was defined as absence of symptoms and soft tissues signs of swelling or sinus tracts and either reduction or complete resolution of a pre-existing radiolucency. An overall success rate of 97.7% post-treatment was attained at 12 months. Of these, 81.8% and 18.2% of teeth showed complete resolution or reduction in radiolucency size, respectively. Considering the very limited sample size (n=45) and narrow inclusion/exclusions criteria, further research including high quality multicenter randomized controlled clinical trials and pragmatic trials with larger sample sizes with a broader inclusion criteria employing longer follow-ups are warranted to demonstrate the efficacy of this system. |
| Best Evidence |
(you may view more info by clicking on the PubMed ID link) |
| PubMed ID |
Author / Year |
Patient Group |
Study type
(level of evidence) |
| #1) 29336878 | Sigurdsson/2018 | 45 teeth with periapical lesions with periapical index ≥ 3 | Prospective clinical study | | Key results | This prospective clinical study is based on 45 first or second molar teeth with periapical lesions with periapical index (PAI) greater than or equal to 3. At 12 months, 43 of 44 teeth were deemed completely functional according to the measured indices of mobility, soft tissue lesions, sinus tract, and furcation involvement. The authors concluded that the GentleWave Procedure resulted in a success rate of 97.7% at 12-month re-evaluation. | | #2) 27325455 | Sigurdsson/2016 | 89 teeth, including 20 teeth with periapical index ≥ 3 | Prospective clinical study | | Key results | This was a prospective clinical study based on 89 first or second molar teeth. Of the seventy-five teeth evaluated at 12 months post-treatment, 72 had irreversible pulpitis and 17 with pulp necrosis. 18 teeth presented with periapical lesions with periapical index (PAI) ≥ 3. Success was defined as absence of post-operative pain, sinus tracts or swelling and either a reduction or complete resolution of a pre-existing radiolucency. The use of the GentleWave resulted in an overall success rate of 97.3% for all teeth treated. Of these, teeth diagnosed with pulp necrosis or irreversible pulpitis had a success rate of 92.9% or 98.4%, respectively. | |
| Evidence Search |
GentleWave[All Fields] AND ("wound healing"[MeSH Terms] OR ("wound"[All Fields] AND "healing"[All Fields]) OR "wound healing"[All Fields] OR "healing"[All Fields]) |
Comments on
The Evidence |
After completing a comprehensive detailed search for relevant evidence on this clinical question, two prospective clinical studies are cited as best current evidence.
A multicenter prospective clinical study published by Sigurdsson A. et al. in 2018 showed a success rate of 97.7% in healing, defined as absence of symptoms or soft tissue abnormalities and either reduction or complete resolution of an existing radiolucency, of first and second molars with periapical lesions with a PAI ≥ 3 at 12 months re-evaluation. A second study also by Sigurdsson A. et al. in 2016 showed a success rate of 92.9% healing of similar periapical lesions. None of the above mentioned studies made use of randomization comparing the dependent measures to a controlled group in the trial. Therefore, without a direct comparison to periapical healing rates after traditional nonsurgical endodontic therapy, an accurate comparison of treatment modalities may not be established.
Both of these studies acknowledge there was funding by Sonendo Inc (the company which developed the GentleWave system). Drs. Sigurdsson and Garland reported that financial affiliations exist for the studies (both are consultants for Sonendo Inc). Further independent studies are warranted due to possible biases and conflicts of interest.
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| Applicability |
The limited evidence presented in these studies shows possible improved healing rates of periapical lesions, however further high quality multicenter randomized controlled clinical trials with no conflict of interest are warranted to demonstrate the efficacy of this system when compared to benchmark procedures. Considering the high cost of this device and limited existing evidence of improved outcomes, including patient-centered outcomes, reduce the enthusiasm for adopting this technology in routine clinical practice. Nonetheless, the technology used in this system to improve debridement and disinfection is promising, and further independent clinical trials could validate its proposed benefit to patients. |
| Specialty/Discipline |
(Endodontics) (General Dentistry) |
| Keywords |
GentleWave, healing, periapical lesions
|
| ID# |
3357 |
| Date of submission: |
11/13/2018 |
| E-mail |
gbenjamindmd@gmail.com |
| Author |
Gary Benjamin, DMD |
| Co-author(s) |
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| Co-author(s) e-mail |
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| Faculty mentor/Co-author |
Anibal Diogenes, DDS, MS, PhD |
| Faculty mentor/Co-author e-mail |
Diogenes@uthscsa.edu |
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?) |
post a rationale |
| None available | |
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Comments and Evidence-Based Updates on the CAT
(FOR PRACTICING DENTISTS', FACULTY, RESIDENTS and/or STUDENTS COMMENTS ON PUBLISHED CATs) |
post a comment |
| None available | |
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