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-
spective, nonsignificant risk clinical studies. Methods:
Forty-five teeth were from 45 patients who met the inclu-
sion criteria and consented for the clinical studies and
were diagnosed with periapical lesions with periapical in-
dex score $3. Patients were treated with a standardized
treatment protocol including instrumentation to an apical
diameter of #20 without orifice enlargement, the Gentle-
Wave Procedure, and warm vertical obturation. Clinical
signs and radiographic assessments were evaluated at
12 months to assess healing. Success was classified as
healing or healed and accounted for the cumulative suc-
cess rate of healing. Statistical analyses were performed
by using Fisher exact test, Pearson correlation, and multi-
variate logistic regression analyses. Results: At 12
months, 44 of 45 teeth (97.8%) were evaluated. The cu-
mulative success rate for the GentleWave Procedure was
97.7%. Forty-three of 44 teeth were completely func-
tional; all teeth had complete resolution for measured
indices of mobility, soft tissue lesions, sinus tract, and
furcation involvement. No patients experienced moder-
ate or severe pain at 2, 7, and 14 days after procedure.
Although only 1 patient was unsuccessful and the pres-
ence of clinical symptoms and type of periradicular diag-
nosis at 12 months were correlated with an unsuccessful
outcome, the analyses were limited by the sample size.
Conclusions: In this case series analysis, treatment of
sizable periapical lesions with the GentleWave Procedure
resulted in a success rate of 97.7% at 12-month re-eval-
uation. (J Endod 2018;44:510–517)
Key Words
GentleWave procedure, healing, molar, Multisonic, peri-
apical index score, periapical lesion, root canal therapy,
Ultracleaning
From the *Department of Endodontics, New York University College of Dentistry, New York, New York; †Garland Endodontics, Encinitas, California; ‡SC Endodontics,
Santa Ana, California; and §Private practice, Aliso Viejo, California
Address requests for reprints to Dr Asgeir Sigurdsson, Department of Endodontics, New York University College of Dentistry, 345 East 24th Street, New York,
NY 10010. E-mail address: endo@simnet.is or asgeir.sigurdsson@nyu.edu
0099-2399/$ - see front matter
Copyright ª 2017 American Association of Endodontists.
https://doi.org/10.1016/j.joen.2017.12.004
510 Sigurdsson et al.
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
to the presence of infec-
high healing rate at 1-year re-evaluation. Postoper-
tion in or around the
ative pain associated with the treatment was mild
root canal system (1).
for all patients.
This inflammation is asso-
ciated with ongoing alter-
ations in the periapical bone, changes that can be identified on periapical
radiographs (2).
Past research has shown that root canal infections must be resolved for the asso-
ciated inflammatory processes to abate and the periapical lesion to heal (3, 4).
However, it is well-accepted that standard therapy does not consistently completely
eradicate biofilm, smear layer, and/or the microorganisms present within the complex-
ities of the root canal system (4). They may remain within the dentinal tubules, affixed
within the apical region, or are challenged by patient-specific morphologic factors such
as lateral canals, ramifications, and isthmi (5, 6). In addition, past research has shown
that standard instruments and rotary files may not completely debride the canals and
leave up to 57% of the root canal system untouched (7).
Limitations with standard endodontic therapy have prompted the development of
root canal therapies such as ultrasonic irrigation, negative pressure irrigation, and laser
technologies among others. By using therapies that include irrigants with potent antimi-
crobial agents, there have been some improvements in cleaning, yet each of these ther-
apies has their own challenges (8). There have been few reported results that predictably
show root canals free of debris and biofilm after treatment with these therapies, and some
reports express safety concerns for a portion of these therapies (9–11). These systems
typically require enlargement of the apical third for adequate depth penetration of
irrigants, with studies reporting canal instrumentation to at least size #35 (8, 12, 13).
This apical enlargement is known to potentially cause various complications including
apical transportation, ledge formation, perforation, and instrument separation while
also removing greater amounts of natural tooth structure that could weaken the root
and may lead to fractures or affect long-term healing rates (14).
The GentleWave System (Sonendo, Inc, Laguna Hills, CA) was developed as an
innovative way to clean and disinfect the root canal system without the need for
over-enlarging the root canals. The GentleWave Procedure uses Multisonic Ultraclean-
ing technology in which advanced fluid dynamics, acoustics, and tissue dissolution
chemistry are applied to clean and disinfect the entire root canal system, regardless
JOE — Volume 44, Number 3, March 2018

of any anatomic complexities (15). Once the GentleWave Procedure has
begun, a stream of optimized fluid is generated that enters the root canal
system, creating a powerful shear force. This causes hydrodynamic cavi-
tation in the form of a cavitation cloud. The implosion of thousands of
microbubbles creates an acoustic field of broadband frequencies that
travels through the procedure fluid into the entire root canal system.
A gentle vortical flow is induced in such a way that it creates a slight
negative pressure inside the root canals. Vapor lock is addressed by
reducing the gas content of the procedure fluids and creating a sealed
platform during the GentleWave Procedure (16–18). A broad spectrum
of acoustic energy is delivered to all anatomic features, with various
lengths ranging from tubules to anastomoses to main canals.
Haapasalo et al (19) reported 7 times faster tissue dissolution with
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
Procedure as compared with standard endodontic therapy (20–22). In
addition, the GentleWave Procedure was shown to cause minimal dentin
erosion (23). Separated hand files within the apical and middle thirds of
root canals have been reported to be removed with the GentleWave Sys-
tem without the need for increased dentin removal (24). Clinical studies
evaluating the GentleWave Procedure have demonstrated success rates
of 97% at 6 and 12 months after GentleWave Procedure (15, 25). In
those 2 studies the preoperative endodontic diagnosis was a mixture
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
cases varied in size (15, 25).
This report of 2 single-arm, multicenter, prospective, nonsignificant
risk clinical studies evaluated the outcomes for a group of patients with
large periapical lesions (periapical index [PAI] score $3) who received
the GentleWave Procedure. The current studies were designed to evaluate
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
evaluated at 12 months after procedure by using a composite end point
that included both clinical and radiographic outcomes to assess healing.
Demographic, clinical, and procedure characteristics were also exam-
ined to assess their associations with clinical outcomes.
Materials and Methods
This analysis was derived from 2 single-arm, multicenter, prospec-
tive, nonsignificant risk clinical studies that were initiated in 2013 and
TABLE 1. Clinical Study Inclusion and Exclusion Criteria
Inclusion criteria
1. The study subject is 18–75 years of age.
2. The subject tooth is indicated for root canal treatment.
3. The subject tooth is a first or second molar.
4. The subject signed an informed consent form.
10. Subject tooth that requires a post.
11. Subject tooth with vertical fracture or horizontal fracture
12. The 2 adjacent teeth in direct contact with the subject tooth
13. Subject has non-odontogenic facial pain.
JOE — Volume 44, Number 3, March 2018
Case Report/Clinical Techniques
2014, respectfully. The study protocols were approved by Aspire insti-
tutional review board (Santee, CA), and the study was performed in
accordance with all applicable laws and regulations including the
Declaration of Helsinki.
Study Subjects
Study subjects were referred for root canal therapy to 4 private
endodontic clinics in Southern California. Forty-five patients were
enrolled after study procedures were explained and informed consent
was obtained. All subjects adhered to the study inclusion and exclusion
criteria as shown in Table 1. All subject teeth included in the analysis
were determined as having the presence of a baseline periapical lesion
(PAI score $3), as determined by 2 blinded, independent evaluators.
Data Collection
Four endodontists participated as investigators and were trained to
use the GentleWave System and follow the clinical study procedures and
standardized treatment protocol. Clinical data were collected by using
standardized coded data sheets. The redacted clinical and radiographic
data were directly transferred to a database.
The standard coded data sheets used subject initials and corre-
sponding subject identification numbers. The investigators ensured
that subject names and data were kept confidential.
Baseline Patient and Clinical Characteristics
Demographics and medical and dental history were collected for
all subjects. The clinical examination involved an intraoral evaluation
that included measurement of periodontal pocket depths, mobility
testing, the presence and extent of swelling and soft tissue lesions, per-
cussion, and palpation.
Radiographic Assessments
A standardized, parallel periapical radiograph was taken for each
study tooth before procedure, after procedure, and at the 12-month re-
evaluation visit. These radiographs were used to assess the periapical
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
blinded examiners evaluated a series of radiographs outside of the study
sample that represented a wide range of periapical lesions. This served
as a standardization exercise for using the PAI scoring system. The
Exclusion criteria
1. Subject tooth had previous or attempted pulpotomy,
pulpectomy, or root canal therapy.
2. Patients reported taking corticosteroids.
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.
extending below the cementoenamel junction of the tooth.
require root canal therapy.
Periapical Healing after GentleWave Procedure 511
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

 Case Report/Clinical Techniques
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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Case Report/Clinical Techniques

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

 Case Report/Clinical Techniques

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
were found to be positively correlated with an unsuccessful outcome,
although the analyses were limited by the low failure rate.
Compared with past studies evaluating standard root canal ther-
apy, the success rate for healing of patients with periapical lesions in
this analysis is higher than most previous reports. Past research by Or-
stavik (3) showed a healed rate of 51% one year after initial endodontic
therapy of anterior, premolar, and molar teeth, with periapical lesions
having a preoperative PAI score of 4 or 5. When the healing category was
added, this success rate went to 88% at 1 year. It should be noted that in
this study of GentleWave Procedure cases, molar teeth with a preoper-
ative PAI score of 4 or 5 had a healing rate of 100% at the 12-month
re-evaluation. Other research has shown that healing of apical peri-
odontitis peaks within the first year after treatment, and that by 1 year
almost 90% of treated teeth demonstrate healing, with only 50% being
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
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
current study in molar teeth, 81.8% were completely healed and
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 outcomes reported herein because the proportion of patient data
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
follow-up. Therefore, some authors may recommend that cases with
incomplete healing should be followed for longer periods of time. How-
ever Orstavik (3) reported that any tooth that has healed will have already
shown signs of healing at 1 year after treatment. In the present study, the
cases were followed for 12 months, with 43 (97.7%) having a reduction
in lesion and 26 (59.1%) with a reduction in at least 2 points from base-
line status, as determined by independent PAI scoring.
The GentleWave Procedure has been shown to clean and disin-
fect all root canals simultaneously through advanced fluid dynamics,
acoustics, and tissue dissolution chemistry (15, 20, 31). Cleaning,
debridement, and disinfection of the root canal system likely
facilitated both healing of the periapical lesion and alveolar bone
regrowth. Resolution of a periapical lesion indicates that the root
canal therapy has been successful by eradication of the existing
infection and healing of the related inflammatory processes in the
surrounding bone (32). Failed root canal treatments are usually
a result of microorganisms that remained in the canals after treat-
ment (29). This is likely due to the limitations of traditional chemo-
mechanical instrumentation as well as the challenges of accessing
morphologic intricacies in the canal system (29). The GentleWave
Procedure has been shown to remove microorganisms from loca-
tions where traditional instruments cannot access because of
anatomic complexities (21).
It is also important to note that the GentleWave Procedure pre-
serves dentin, which is crucial because greater clinical success in
endodontics has been correlated to the maintenance of the patient’s
original canal shape and lack of any canal aberrations (33). Lesion
healing involves a dynamic process (34), because healing is depen-
dent not only on the efficacy of the disinfection process but also on
the host response to remaining debris or biofilm that is traditionally
not removed with standard root canal therapy (34). In addition,
because the GentleWave Procedure has been shown to effectively re-
move smear layer and biofilm (35) and to reach intricate canal
spaces, this effective dissolution process likely contributed to the
high success rate in this study.
Conclusions
Endodontic therapy should protect or heal inflamed periapical
tissue (2). In this prospective study of patients with significantly large
periapical lesions in molar teeth, the success rate for healing was
97.7% after treatment with the GentleWave Procedure. No baseline
patient or tooth characteristics were found to be associated with a
poor outcome. Although the failure group included only 1 patient
(n = 1), symptomatic apical periodontitis at 12-month follow-up
was found to be positively correlated with an unsuccessful outcome,
and therefore any future investigations require additional interpreta-
tion. This analysis showed that patients with periapical lesions, as
determined by a PAI score $3, are excellent candidates for the Gen-
tleWave Procedure and that 97.7% of lesions resolve and the affected
teeth regain clinical and functional normalcy within 12 months after
treatment.
516 Sigurdsson et al.
Acknowledgments
The authors acknowledge that Drs Khang T. Le, Shahriar A.
Rassoulian, and Randy W. Garland were participating investigators
and treating clinicians in the clinical studies.
The clinical study is funded in part by Sonendo Inc. Drs. Si-
gurdsson and Garland report that financial affiliations exist for
this paper (both are consultants for Sonendo Inc).
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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