Case Report/Clinical Techniques

Healing of Periapical Lesions after Endodontic

Treatment with the GentleWave Procedure:
A Prospective Multicenter Clinical Study
Asgeir Sigurdsson, DDS, MS,* Randy W. Garland, DDS,† Khang T. Le, DDS,‡
and Shahriar A. Rassoulian, DMD§

Abstract
Introduction: This report includes outcomes for a group
of patients with significant periapical lesions who were
treated and evaluated in two single-arm, multicenter, pro-
A pical periodontitis is
an inflammatory reac-
tion of the immune system
Significance
Teeth with necrotic pulps and large periapical le-
sions treated with GentleWave procedure had
spective, nonsignificant risk clinical studies. Methods: to the presence of infec-
high healing rate at 1-year re-evaluation. Postoper-
Forty-five teeth were from 45 patients who met the inclu- tion in or around the
ative pain associated with the treatment was mild
sion criteria and consented for the clinical studies and root canal system (1).
for all patients.
were diagnosed with periapical lesions with periapical in- This inflammation is asso-
dex score $3. Patients were treated with a standardized ciated with ongoing alter-
treatment protocol including instrumentation to an apical ations in the periapical bone, changes that can be identified on periapical
diameter of #20 without orifice enlargement, the Gentle- radiographs (2).
Wave Procedure, and warm vertical obturation. Clinical Past research has shown that root canal infections must be resolved for the asso-
signs and radiographic assessments were evaluated at ciated inflammatory processes to abate and the periapical lesion to heal (3, 4).
12 months to assess healing. Success was classified as However, it is well-accepted that standard therapy does not consistently completely
healing or healed and accounted for the cumulative suc- eradicate biofilm, smear layer, and/or the microorganisms present within the complex-
cess rate of healing. Statistical analyses were performed ities of the root canal system (4). They may remain within the dentinal tubules, affixed
by using Fisher exact test, Pearson correlation, and multi- within the apical region, or are challenged by patient-specific morphologic factors such
variate logistic regression analyses. Results: At 12 as lateral canals, ramifications, and isthmi (5, 6). In addition, past research has shown
months, 44 of 45 teeth (97.8%) were evaluated. The cu- that standard instruments and rotary files may not completely debride the canals and
mulative success rate for the GentleWave Procedure was leave up to 57% of the root canal system untouched (7).
97.7%. Forty-three of 44 teeth were completely func- Limitations with standard endodontic therapy have prompted the development of
tional; all teeth had complete resolution for measured root canal therapies such as ultrasonic irrigation, negative pressure irrigation, and laser
indices of mobility, soft tissue lesions, sinus tract, and technologies among others. By using therapies that include irrigants with potent antimi-
furcation involvement. No patients experienced moder- crobial agents, there have been some improvements in cleaning, yet each of these ther-
ate or severe pain at 2, 7, and 14 days after procedure. apies has their own challenges (8). There have been few reported results that predictably
Although only 1 patient was unsuccessful and the pres- show root canals free of debris and biofilm after treatment with these therapies, and some
ence of clinical symptoms and type of periradicular diag- reports express safety concerns for a portion of these therapies (9–11). These systems
nosis at 12 months were correlated with an unsuccessful typically require enlargement of the apical third for adequate depth penetration of
outcome, the analyses were limited by the sample size. irrigants, with studies reporting canal instrumentation to at least size #35 (8, 12, 13).
Conclusions: In this case series analysis, treatment of This apical enlargement is known to potentially cause various complications including
sizable periapical lesions with the GentleWave Procedure apical transportation, ledge formation, perforation, and instrument separation while
resulted in a success rate of 97.7% at 12-month re-eval- also removing greater amounts of natural tooth structure that could weaken the root
uation. (J Endod 2018;44:510–517) and may lead to fractures or affect long-term healing rates (14).
The GentleWave System (Sonendo, Inc, Laguna Hills, CA) was developed as an
Key Words innovative way to clean and disinfect the root canal system without the need for
GentleWave procedure, healing, molar, Multisonic, peri- over-enlarging the root canals. The GentleWave Procedure uses Multisonic Ultraclean-
apical index score, periapical lesion, root canal therapy, ing technology in which advanced fluid dynamics, acoustics, and tissue dissolution
Ultracleaning chemistry are applied to clean and disinfect the entire root canal system, regardless

From the *Department of Endodontics, New York University College of Dentistry, New York, New York; †Garland Endodontics, Encinitas, California; ‡SC Endodontics,
Santa Ana, California; and §Private practice, Aliso Viejo, California
Address requests for reprints to Dr Asgeir Sigurdsson, Department of Endodontics, New York University College of Dentistry, 345 East 24th Street, New York,
NY 10010. E-mail address: [email protected] or [email protected]
0099-2399/$ - see front matter
Copyright ª 2017 American Association of Endodontists.
https://doi.org/10.1016/j.joen.2017.12.004

510 Sigurdsson et al. JOE — Volume 44, Number 3, March 2018

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of any anatomic complexities (15). Once the GentleWave Procedure has 2014, respectfully. The study protocols were approved by Aspire insti-
begun, a stream of optimized fluid is generated that enters the root canal tutional review board (Santee, CA), and the study was performed in
system, creating a powerful shear force. This causes hydrodynamic cavi- accordance with all applicable laws and regulations including the
tation in the form of a cavitation cloud. The implosion of thousands of Declaration of Helsinki.
microbubbles creates an acoustic field of broadband frequencies that
travels through the procedure fluid into the entire root canal system. Study Subjects
A gentle vortical flow is induced in such a way that it creates a slight
Study subjects were referred for root canal therapy to 4 private
negative pressure inside the root canals. Vapor lock is addressed by
endodontic clinics in Southern California. Forty-five patients were
reducing the gas content of the procedure fluids and creating a sealed
enrolled after study procedures were explained and informed consent
platform during the GentleWave Procedure (16–18). A broad spectrum
was obtained. All subjects adhered to the study inclusion and exclusion
of acoustic energy is delivered to all anatomic features, with various
criteria as shown in Table 1. All subject teeth included in the analysis
lengths ranging from tubules to anastomoses to main canals.
were determined as having the presence of a baseline periapical lesion
Haapasalo et al (19) reported 7 times faster tissue dissolution with
(PAI score $3), as determined by 2 blinded, independent evaluators.
the GentleWave System than with standard root canal systems, including
sonic and ultrasonic devices. Past studies have provided evidence of su-
perior debris, smear layer, and bacterial removal after the GentleWave Data Collection
Procedure as compared with standard endodontic therapy (20–22). In Four endodontists participated as investigators and were trained to
addition, the GentleWave Procedure was shown to cause minimal dentin use the GentleWave System and follow the clinical study procedures and
erosion (23). Separated hand files within the apical and middle thirds of standardized treatment protocol. Clinical data were collected by using
root canals have been reported to be removed with the GentleWave Sys- standardized coded data sheets. The redacted clinical and radiographic
tem without the need for increased dentin removal (24). Clinical studies data were directly transferred to a database.
evaluating the GentleWave Procedure have demonstrated success rates The standard coded data sheets used subject initials and corre-
of 97% at 6 and 12 months after GentleWave Procedure (15, 25). In sponding subject identification numbers. The investigators ensured
those 2 studies the preoperative endodontic diagnosis was a mixture that subject names and data were kept confidential.
of vital and non-vital pulps, where only 14 of the total sample were diag-
nosed as being necrotic, and the periapical lesions associated with those Baseline Patient and Clinical Characteristics
cases varied in size (15, 25).
Demographics and medical and dental history were collected for
This report of 2 single-arm, multicenter, prospective, nonsignificant
all subjects. The clinical examination involved an intraoral evaluation
risk clinical studies evaluated the outcomes for a group of patients with
that included measurement of periodontal pocket depths, mobility
large periapical lesions (periapical index [PAI] score $3) who received
testing, the presence and extent of swelling and soft tissue lesions, per-
the GentleWave Procedure. The current studies were designed to evaluate
cussion, and palpation.
the rates of healing in a population of patients requiring initial molar root
canal therapy. Consecutive patients who consented for participation in the
study were treated with the GentleWave Procedure, and outcomes were Radiographic Assessments
evaluated at 12 months after procedure by using a composite end point A standardized, parallel periapical radiograph was taken for each
that included both clinical and radiographic outcomes to assess healing. study tooth before procedure, after procedure, and at the 12-month re-
Demographic, clinical, and procedure characteristics were also exam- evaluation visit. These radiographs were used to assess the periapical
ined to assess their associations with clinical outcomes. lesion at each time point and were used for independent radiographic
analysis by 2 blinded, independent evaluators. Before evaluation and
scoring of the study radiographic images, the 2 independent and
Materials and Methods blinded examiners evaluated a series of radiographs outside of the study
This analysis was derived from 2 single-arm, multicenter, prospec- sample that represented a wide range of periapical lesions. This served
tive, nonsignificant risk clinical studies that were initiated in 2013 and as a standardization exercise for using the PAI scoring system. The

TABLE 1. Clinical Study Inclusion and Exclusion Criteria

Inclusion criteria Exclusion criteria
1. The study subject is 18–75 years of age. 1. Subject tooth had previous or attempted pulpotomy,
2. The subject tooth is indicated for root canal treatment. pulpectomy, or root canal therapy.
3. The subject tooth is a first or second molar. 2. Patients reported taking corticosteroids.
4. The subject signed an informed consent form. 3. Any known infectious diseases (eg, human immunodeficiency
virus, hepatitis B, hepatitis C, tuberculosis, bovine spongiform
encephalopathy, or prion).
4. History of cancer within the oral-maxillofacial region.
5. History of cancer within the last 2 years.
6. History of head and/or neck radiation therapy.
7. Subject tooth with mobility score $2.
8. Subject tooth with periodontal pocket depth $6 mm.
9. Subject tooth with open or incompletely formed root apices.
10. Subject tooth that requires a post.
11. Subject tooth with vertical fracture or horizontal fracture
extending below the cementoenamel junction of the tooth.
12. The 2 adjacent teeth in direct contact with the subject tooth
require root canal therapy.
13. Subject has non-odontogenic facial pain.

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Case Report/Clinical Techniques
exercise was independently performed 3 times to increase the calibra-
tion and interobserver agreement between the examiners.
Radiographs of the roots under study were each assigned a PAI
score by the independent examiners under standardized conditions.
The highest PAI score for all the roots for a given tooth was considered
as the PAI score of the tooth. After independent scoring, the examiners
reached an agreement on the PAI scores only if the scores of their in-
dependent evaluations differed. The consensus scores for all radio-
graphic images were considered as the final score at each visit and
were used for statistical analyses.

Study Procedure
The study investigators were trained to use the GentleWave System
and performed a standardized procedure at their independent private
clinical sites. Before the GentleWave Procedure, the patient was anesthe-
tized per standard techniques; the type of anesthetic was left to the
discretion of the endodontist. The tooth was isolated with a dental
dam, and any existing caries and restorations were removed.
The GentleWave Procedure was conducted in the following
manner. A conservative straight-line access opening was prepared,
with removal of all pulp horns and ledges. To preserve tooth structure,
orifice openers were not used during the instrumentation process.
Patency was gained with #10 and #15 K-type files, and working lengths
were confirmed. ProTaper rotary files (Dentsply, Tulsa Dental Spe-
cialties, Tulsa, OK) up to an apical diameter of #20 were used to
create a fluid and obturation path before the GentleWave Procedure.
A temporary build-up was placed to maintain a sealed environment for
optimum Multisonic Ultracleaning during the GentleWave Procedure
(Fig. 1). The GentleWave Procedure was then used to remove pulp
tissue remnants, debris, smear layer, and bacteria from the entire Figure 1. The GentleWave procedure. The GentleWave Procedure cleans and
root canal system (15, 19, 20, 22). Each canal was subsequently disinfects the root canal system through generation of sound waves (multisonic
waves) that are initiated at the tip of the procedure instrument. Optimized pro-
dried with paper points and obturated with gutta-percha and AH
cedure fluid enters the root canal system, creating a powerful shear force,
Plus sealer (Dentsply Tulsa Dental Specialties) by using a warm ver- which causes hydrodynamic cavitation in the form of a cavitation cloud.
tical technique. The pulp chamber floor was sealed with bonded com- This continuous formation of thousands of microbubbles, combined with
posite, and patients were referred to a general dentist for final post- the multisonic energy and fluid dynamics, results in the dissolution and
procedure restoration. removal of pulp tissue and debris (15).
Postoperative pain was evaluated by using the visual analogue scale
(VAS), a visual tool that uses a 10-cm line anchored by values of 0 and
10. Patients were asked to assess their pain before procedure and at 2, The final treatment outcome was dichotomous; teeth classified as
7, and 14 days after treatment, as well as at each re-evaluation visit. healed or healing at 12 months after procedure were considered suc-
cesses, and diseased teeth were considered unsuccessful.
Outcomes
The outcome of interest was healing by using a composite measure Statistical Analyses
of clinical and radiographic components. The clinical signs and symp- A Cohen kappa score was calculated to assess the level of agree-
toms composed the clinical component and included evaluation of peri- ment between the independent examiners of the study radiographs.
odontal pocket depths, mobility, soft tissue lesions, presence and extent Univariate and bivariate analyses with percentage of frequencies
of swelling, percussion, and palpation. The radiographic component were generated to characterize the study subjects. Bivariate analyses
was composed of independent PAI scoring using periapical radio- (Fisher exact test) were used to evaluate differences in patient and clin-
graphs. ical characteristics. Univariate logistic regressions and Pearson coeffi-
On the basis of the composite end point at the 12-month re- cients were calculated to determine any correlation between these
evaluation visit, teeth were classified as healed, healing, or diseased. variables to categorize potential outcome predictors. Finally, factors
In summary, the treated teeth were classified as follows: with a P value <.10 in the univariate analysis were included in a multi-
variate analysis. Odds ratios and 95% confidence intervals (CIs) were
1. Healed: clinical normalcy other than tenderness to percussion calculated. SAS v9.4 (SAS Institute, Cary, NC) was used to perform
accompanied by radiographic PAI scores of 1 or 2. The lesion is the analyses. All the tests were performed as 2-tailed with a significance
no longer present/no periapical radiolucency. level of 5%.
2. Healing: clinical normalcy other than tenderness to percussion
accompanied by a reduction in the size of the periradicular lesion
and a reduction in the PAI score. Results
3. Diseased: the presence of clinical signs and symptoms accompanied Radiographic Examiner Reliability
by a PAI score of 3 or higher or an increase in the size of the peri- Before evaluation of the standardized radiographs, the 2 indepen-
radicular lesion or an increase in the PAI score. dent examiners were assessed for interobserver agreement. The Cohen

512 Sigurdsson et al. JOE — Volume 44, Number 3, March 2018

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TABLE 2. Bivariate Analyses Showing Unadjusted Effects of Pre-procedure, TABLE 2. (continued )
Intra-procedure, and Post-procedure Characteristics Compared with the
Variables n (%) P value
Outcome of Healing
Restoration
Variables n (%) P value Temporary filling material 6 (13.6) 1.00
Pre-procedure Permanent crown 38 (86.4)
Patients 45 (100) Crown and bite issues 25 (65.8)
Age (y) Periodontal issue
#35 21 (46.7) 1.00 Present 16 (36.4) 1.00
Sex Clinical symptoms
Male 24 (53.3) 1.00 Present† 1 (2.3) .02
Oral hygiene Mobility
Good 30 (66.7) 1.00 Present 0 (0) NA
Fair 15 (33.3) Soft tissue lesion
Diabetic history 1 (2.2) 1.00 Present 0 (0) NA
Cardiovascular history 4 (8.9) 1.00 Sinus tract
Tobacco use 3 (6.7) 1.00 Present 0 (0) NA
Medication Palpation sensitivity
Pain 12 (26.7) 1.00 Present† 1 (2.3) .02
Antibiotic 30 (66.7) 1.00 Percussion sensitivity
Anti-inflammatory 29 (64.4) 1.00 Present† 1 (2.3) .02
Maxillary molars 12 (26.7) 1.00 Furcation involvement
Right molars 21 (46.7) .45 Present 0 (0) NA
Probing pocket depth Probing pocket depth
#3 38 (84.4) 1.00 #3 40 (90.9) .09
>4–5 7 (15.6) 4 4 (9.1)
Clinical symptoms 33 (73.3) Periradicular diagnosis
Mobility I Normal periradicular tissue 27 (61.4) .05
Present 3 (6.7) 1.00 Healing within normal limits 15 (34.1)
Soft tissue lesion Asymptomatic apical periodontitis 1 (2.3)
Present 6 (13.3) 1.00 Symptomatic apical periodontitis† 1 (2.3)
Sinus tract Chronic apical abscess 0 (0)
Present 8 (17.8) 1.00 Acute apical abscess 0 (0)
Palpation sensitivity PAI scores
Present 17 (37.8) .39 <3 36 (81.8) .018
Percussion sensitivity 3 8 (18.2)
Present 29 (64.4) 1.00 >3 0 (0)
Furcation involvement Reduction in lesion
Present 1 (2.2) 1.00 Present 43 (97.7) .02
Periradicular diagnosis Change of $2 in PAI score from 26 (59.1) .41
Normal periradicular tissue 0 (0) 1.00 baseline
Asymptomatic apical periodontitis 11 (24.4) Healing rate
Symptomatic apical periodontitis 23 (51.1) Success 43 (97.7)
Chronic apical abscess 7 (15.6) Healed 36 (81.8)
Acute apical abscess 4 (8.9) Healing 7 (15.9)
PAI scores Diseased 1 (2.3)
3 33 (73.3) 1.00
NA, not applicable.
4 10 (22.2)
5 2 (4.4) Bold values are significant at the .05 level (2-tailed).
Intra-procedure *One canal was located after GentleWave Procedure and was obturated without instrumentation.
†
No. of visits One patient exhibited all noted clinical symptoms at 12 months.
Single 40 (88.9) 1.00
No. of canals* 156 (100)
Final apical diameter
kappa score between the independent reviewers was 0.83 and 0.84,
0.2 mm 156 (100) 1.00 indicating a strong level of agreement.
Calcification 28 (18.1) 1.00
Coronal 12 (7.7)
Middle 12 (7.7) Pre-procedure, Intra-procedure, and 12-Month Follow-up
Apical 22 (14.2) Factors
Obturation type* Pre-procedure, intra-procedure, and 12-month follow-up patient
Warm vertical compaction 157 (100) characteristics are displayed in Table 2. Forty-five patients met the study
Root filling length
Short: >2 mm above the apex 4 (2.6) 1.00 inclusion criteria and were enrolled across the 4 clinical sites. At the
Flush: within 2 mm of the apex 151 (96.8) time of the 12-month re-evaluation, 44 subjects (97.8%) were avail-
Long: >2 mm below the apex 1 (0.6) able; 1 patient was lost to follow-up.
Sealer extrusion The mean
standard deviation age of patients was 37
11 years,
Present 94 (60.3) 1.00
Coronal seal
with a range of 19–68 years. The sex distribution was fairly balanced,
Present 44 (100) 1.00 with 53.3% men and 46.7% women. Oral hygiene of the study subjects
Post-procedure: 12-month follow-up was classified as good (66.7%) or fair (33.3%). Few comorbidities
Patients 44 (97.8) were noted, 2.2% with a history of diabetes and 8.9% with a history
(continued ) of cardiovascular conditions. Clinical symptoms were present in

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Figure 2. Mandibular molar with lateral canals treated with the GentleWave system. Representative radiographs showing mesial and distal roots of tooth #18. (A)
shows the presence of a periapical lesion on both the mesial and distal roots before the GentleWave Procedure. The root canals were shaped to an apical diameter of
#20 and were obturated with gutta-percha and AH Plus by using warm vertical technique. (B) highlights the distal lateral canal and apical delta that are able to be
thoroughly cleaned with the GentleWave Procedure. (C and D) show the healing of the periapical lesions at 6 and 12 months after GentleWave Procedure. (A) Pre-
procedure with the GentleWave System. (B) Immediate post-procedure. (C) 6 months post-procedure. (D) 12 months post-procedure. Periapical healing can be
seen on the 12-month re-evaluation visit radiographs.

73.3% of patients, with 6.7% experiencing mobility, 17.8% having a si- Bivariate, Univariate, and Multivariate Analysis
nus tract, and 13.3% with soft tissue lesions. Exacerbated apical peri- The influence of patient and clinical characteristics on the
odontitis was present in 15.6% of patients with chronic apical outcome of interest was analyzed (Tables 2 and 3). Bivariate analyses
abscess and 8.9% with acute apical abscess. showed no significant differences in pre-procedure and intra-
In total, 45 teeth in 45 patients received endodontic treatment procedure characteristics between those who had a successful outcome
with the GentleWave Procedure, resulting in the disinfection and and those who did not. The presence of clinical symptoms (P = .02) and
cleaning of 154 canals. Of note, the majority of study teeth type of periarticular diagnosis (P = .05) at 12 months after procedure
(n = 40, 88.9%) were treated with single-visit endodontics. Of those were associated with an unsuccessful outcome, although the univariate
who were treated with 2 visits (n = 5), 3 were treated in multiple and multivariate analyses were limited by the single subject in the failure
visits because of time constraints, 1 was due to a separated file, group. Analyses of the pooled sample revealed that the outcome of in-
and 1 was due to device availability. terest was not associated with any of the patient or clinical variables.
Clinical measurements showed improvements for all the measured
indices, with mobility, soft tissue lesions, sinus tract, and furcation
involvement all showing resolution at 12 months (Table 2). Only 1 pa- Discussion
tient presented with any clinical symptoms, both percussion and palpa-
Anaerobic and aerobic microorganisms are typically found in
tion sensitivity. At 12 months, a reduction in the periapical lesion size
teeth with infected or necrotic pulp (26–28). In the endodontic
was present in 43 teeth (97.7%) (Figs. 2–4); all these teeth were
therapy of teeth with infected pulpal space and periapical lesions, the
reported as functional. Regarding the primary outcome of interest,
primary goal is the removal of infection and the prevention of
the composite measurement showed that 36 teeth were healed, 7
microorganisms from infecting or reinfecting the root and
teeth were healing, and 1 was diseased. The proportion of teeth with
surrounding tissues (29).
a successful outcome was 43 of 44 (97.7%).
In this prospective study of patients with significant periapical le-
sions in molar teeth, a 97.7% healing rate at 12 months after endodontic
Incidence of Pain therapy with the GentleWave Procedure was achieved. This study pop-
Incidence of pain was also evaluated by using a VAS scale. Preop- ulation included patients within a wide age range and representation
erative evaluation indicated 17.8% of patients reported mild pain and from both sexes. Existing comorbidities such as diabetes and cardiovas-
4.4% of patients reported moderate pain. At 2 days after procedure, cular disease did not appear to hinder successful healing in these pa-
only 7 patients (15.6%) reported mild pain (VAS #6). At 2, 7, and tients, suggesting that the GentleWave Procedure may lead to
14 days after procedure, no patients experienced moderate or severe successful outcomes even in those with conditions known to impede
pain (VAS scores of 7 to $9). No pain was reported at the 6- and healing after root canal therapy. No baseline patient or tooth character-
12-month follow-up visits. istics were found to be associated with a poor outcome. Symptomatic

Figure 3. Acute apical abscess treated with the GentleWave System. Representative radiographs showing mesial and distal roots of tooth #31. (A) shows the pres-
ence of periapical lesion on both the mesial and distal roots before the GentleWave Procedure. Root canals were shaped to apical diameter of #20 and were ob-
turated with gutta-percha and AH Plus by using warm vertical technique. (C and D) show the healing of periapical lesions at 6 and 12 months after GentleWave
Procedure. (A) Pre-procedure with the GentleWave System. (B) Immediate post-procedure. (C) 6 months post-procedure. (D) 12 months post-procedure. Peri-
apical healing can be seen on the 12-month re-evaluation visit radiographs.

514 Sigurdsson et al. JOE — Volume 44, Number 3, March 2018

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Figure 4. Mandibular molar treated with the GentleWave System. Representative radiographs showing mesial and distal roots of tooth #31. (A) shows the presence
of periapical lesion on both the mesial and distal roots before the GentleWave Procedure. Root canals were shaped to apical diameter of #20 and were obturated
with gutta-percha and AH Plus by using warm vertical technique. (B) highlights a furcation lateral canal filled after GentleWave Procedure. (C and D) show the
healing of periapical lesions at 6 and 12 months after GentleWave Procedure. (A) Pre-procedure with the GentleWave System. (B) Immediate post-procedure. (C) 6
months post-procedure. (D) 12 months post-procedure. Periapical healing can be seen on the 12-month re-evaluation visit radiographs.

apical periodontitis and probing depths of >3 at 12-month follow-up having a preoperative PAI score of 4 or 5. When the healing category was
were found to be positively correlated with an unsuccessful outcome, added, this success rate went to 88% at 1 year. It should be noted that in
although the analyses were limited by the low failure rate. this study of GentleWave Procedure cases, molar teeth with a preoper-
Compared with past studies evaluating standard root canal ther- ative PAI score of 4 or 5 had a healing rate of 100% at the 12-month
apy, the success rate for healing of patients with periapical lesions in re-evaluation. Other research has shown that healing of apical peri-
this analysis is higher than most previous reports. Past research by Or- odontitis peaks within the first year after treatment, and that by 1 year
stavik (3) showed a healed rate of 51% one year after initial endodontic almost 90% of treated teeth demonstrate healing, with only 50% being
therapy of anterior, premolar, and molar teeth, with periapical lesions healed (30). Although the study by Orstavik included anterior and

TABLE 3. Odds Ratios and Pearson Correlation of Selected Unweighted Variables Associated with Healing Outcome
Variables N % Success Odds ratio (95% CI) Pearson correlation (95% CI)
Age (y) 2.62 (0.09–73.27) 0.14 (–0.17 to 0.42)
#35 20 100
>35 24 95.8
Gender 0.35 (0.01–9.74) 0.15 (0.42 to 0.16)
Male 23 95.7
Female 21 100.0
Oral hygiene 0.61 (0.02–17.54) 0.11 (.039 to 0.19)
Good 29 96.6
Fair 15 100.0
Molars 1.19 (0.04–34.94) 0.09 (.021 to 0.38)
Maxillary 12 100.0
Mandibular 32 96.9
Pre-procedure palpation sensitivity 0.20 (0.01–5.57) 0.19 (0.46 to 0.11)
Present 17 94.1
Absent 27 100.0
Pre-procedure percussion sensitivity 0.56 (0.02–15.80) 0.12 (0.40 to 0.19)
Present 28 96.4
Absent 16 100.0
Pre-procedure PAI scores 0.87 (0.07–10.41) 0.09 (0.22 to 0.37)
3 32 96.9
4 10 100.0
5 2 100.0
No. of visits (single) 39 97.4 2.33 (0.07–83.36) 0.05 (0.35 to 0.25)
Post-procedure clinical symptoms 1 0.0 NA 1.0
Palpation sensitivity 1 0.0 NA 1.0
Percussion sensitivity 1 0.0 NA 1.0
Probing pocket depth 34.71 (1.01–1198.79) 0.48 (0.21–0.68)
#3 40 100.0
4 4 75.5
Periradicular diagnosis 0.10 (0.01–0.99) 0.59 (0.75 to 0.35)
Normal periradicular tissue 27 100.0
Healing within normal limits 15 100.0
Asymptomatic apical periodontitis 1 100.0
Symptomatic apical periodontitis 1 0.0
PAI scores 0.19 (0.02–2.13) 0.26 (0.51 to 0.04)
<3 36 100.0
3 8 87.5
Reduction in lesion 43 100.0 NA 1.00
NA, not applicable.
Bold values are significant at the .05 level (2-tailed).

JOE — Volume 44, Number 3, March 2018 Periapical Healing after GentleWave Procedure 515
Case Report/Clinical Techniques
premolar teeth, the success rate in the current study (which includes Acknowledgments
only molar teeth) shows much higher success at close to 98% at the
1-year evaluation. Using similar criteria for success or failure, for the The authors acknowledge that Drs Khang T. Le, Shahriar A.
Rassoulian, and Randy W. Garland were participating investigators
current study in molar teeth, 81.8% were completely healed and
and treating clinicians in the clinical studies.
15.9% were healing. Only 1 patient, 2.2% of study population, was
lost to follow-up. Missing data from this patient are unlikely to skew The clinical study is funded in part by Sonendo Inc. Drs. Si-
gurdsson and Garland report that financial affiliations exist for
the outcomes reported herein because the proportion of patient data
this paper (both are consultants for Sonendo Inc).
that was unavailable is quite small.
The success rate for the study is 97.7% and is a composite end point
that includes 7 cases (15.9%) with a healing designation at 12-month References
follow-up. Therefore, some authors may recommend that cases with 1. Kakehashi S, Stanley HR, Fitzgerald RJ. The effects of surgical exposures of dental
incomplete healing should be followed for longer periods of time. How- pulps in germ-free and conventional laboratory rats. Oral Surg Oral Med Oral Pathol
ever Orstavik (3) reported that any tooth that has healed will have already 1965;20:340–9.
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CORRIGENDA
Corrigendum to ‘Complicated Root Canal Morphology of Mandibular Lateral Incisors Is Associated with the Presence of Distolingual Root
in Mandibular First Molars: A Cone-beam Computed Tomographic Study in a Taiwanese Population’ [Journal of Endodontics 44 (2018)
73–79.e1]

Yu-Chiao Wu, DDS,* Wan-Chien Cheng, DDS, PhD,† Ming-Pang Chung, DDS,* Chi-Chun Su, DDS,* Pei-Wei Weng, MD, PhD,‡§ Yi-Wen Cathy Tsai,
DDS,† Ho-Sheng Chiang, DDS,* Hsiao-Wen Yeh, DDS,* Chi-Hsiang Chung, PhD,k Yi-Shing Shieh, DDS, PhD,* and Ren-Yeong Huang, DDS, PhD†
From the Departments of *Operative Dentistry and Endodontics and †Periodontology, School of Dentistry, Tri-Service General Hospital and
National Defense Medical Center, ‡Department of Orthopaedics, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan,
§
Department of Orthopaedics, School of Medicine, College of Medicine, Taipei Medical University, and kSchool of Public Health, National
Defense Medical Center, Taipei, Taiwan.

The authors regret that a typing error was made to the IRB number listed in this article. The correct IRB number should be ‘‘2-105-05-078.’’
The authors would like to apologize for any inconvenience caused.

Corrigendum to ‘Complicated Root Canal Configuration of Mandibular First Premolars Is Correlated with the Presence of the Distolingual
Root in Mandibular First Molars: A Cone-beam Computed Tomographic Study in Taiwanese Individuals’ [Journal of Endodontics 43
(2017) 1064–1071]

Yu-Chiao Wu, DDS,* Chi-Chun Su, DDS,* Yi-Wen Cathy Tsai, DDS,† Wan-Chien Cheng, DDS, PhD,† Ming-Pang Chung, DDS,* Ho-Sheng Chiang,
DDS,* Chen-Yu Hsieh, DDS,* Chi-Hsiang Chung, PhD,‡ Yi-Shing Shieh, DDS, PhD,* and Ren-Yeong Huang, DDS, PhD†
From the Departments of *Operative Dentistry and Endodontics and †Periodontology, School of Dentistry, Tri-Service General Hospital and
National Defense Medical Center; and ‡School of Public Health, National Defense Medical Center, Taipei, Taiwan.

The authors regret that a typing error was made to the IRB number listed in this article. The correct IRB number should be ‘‘2-105-05-078.’’
The authors would like to apologize for any inconvenience caused.

JOE — Volume 44, Number 3, March 2018 Periapical Healing after GentleWave Procedure 517