Journal of the World Federation of Orthodontists 6 (2017) 127e130

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Original Research

Incidence of white spot lesions during orthodontic clear aligner

therapy
Muhammad Azeem a, *, Waheed Ul Hamid b
a
Assistant Professor, Orthodontics, Health Department Government of Punjab, Lahore / Faisalabad Medical University, Pakistan
b
Dean and Professor, Head of Orthodontics, de’Montmorency College of Dentistry, Lahore, Pakistan

a r t i c l e i n f o a b s t r a c t

Article history: Introduction: There are many studies available regarding the incidence of while spot lesion (WSL)
Received 23 June 2017 development during fixed appliance therapy, but there is not enough equivalent information concerning
Received in revised form incidence of WSL with clear aligner therapy. Therefore, the aim of present study was to assess the
21 July 2017
incidence of WSL formation in subjects treated with clear aligner therapy.
Accepted 26 July 2017
Methods: This study was conducted on pretreatment and posttreatment quantitative light-induced
fluorescence images of 25 orthodontic patients (12 boys, 13 girls; mean age, 16.17
1.76 years)
treated with clear aligner therapy protocol. The records included each patient’s age, sex, and time points
Keywords:
Adolescents
of start and end of clear aligner therapy. The primary outcome measures were sound enamel and the
Clear aligners numbers of WSLs. Nonparametric analysis of variance was performed, taking into account the patients’
Invisalign grouped ages, sexes, and treatment timings. The Statistical Package for the Social Sciences (version 20.0)
White spot lesions was used for data analysis. P < 0.05 indicated statistical significance.
Results: The overall incidence of new WSLs was 2.85% for all the assessed teeth. Twenty-eight percent of
the patients were affected by at least one new WSL, when all the accessed teeth were considered. Fre-
quencies of WSLs were not significantly different in different age and gender groups; however, treatment
time had a significant impact on WSL formation in maxillary incisors.
Conclusion: Orthodontic treatment with clear aligner therapy showed a low incidence of newly devel-
oped WSLs.
Ó 2017 World Federation of Orthodontists.

1. Introduction
White spot lesions (WSLs) are clinically defined as opaque,
white areas caused by the subsurface loss of enamel minerals [1].
Orthodontic patients with fixed appliance therapy are more sus-
ceptible to the development of WSLs, than untreated patients
because of impaired oral hygiene and increased plaque retention
sites [2]. The introduction of removable clear aligners meant a step
forward in the treatment of orthodontic conditions. Several
approaches are available for diagnosis of WSLs, including fiberoptic
transillumination [3], ultraviolet light [4], fluorescent dye uptake
[5], laser fluorescence [6], and photographic images [7].
Estimates of the WSLs arising during fixed appliance therapy
showed an incidence of at least one new WSL of 46% within 1 year,
14 or 36% for upper and lower incisors, and 61% for upper incisors
* Corresponding author: Orthodontic Department, Health Department Govern-
ment of Punjab, Lahore / Faisalabad Medical University, Pakistan 54000.
E-mail address: dental.concepts@hotmail.com (M. Azeem).
[8e10]. Overall incidence of 72.9% has been found for maxillary and
mandibular teeth, including the first molars [11]. Many studies have
been done to determine the best prevention and treatment of WSLs.
Most studies aimed at the prevention and treatment of WSLs by
using topical fluoride toothpastes and mouthwashes, antibacterial
orthodontic adhesives, fluoride varnishes or gels, and more recently
laser irradiation and resin infiltration [1,12e16].
Many orthodontic patients adopt clear aligner therapy instead of
fixed appliance treatment for social reasons. Clear aligner trays are
usually prescribed to be worn approximately 22 hours per day for
optimal results. However, by covering teeth, flow of saliva is limited,
and self-cleansing activities of orofacial soft tissues is interrupted,
allowing further entrapment and development of plaque under the
aligners [17]. Additionally, many patients drink acidic beverages
with aligners in place, which allows further entrapment beneath
the aligners. Birdsall and Robinson [18] described a former ortho-
dontic patient with a lower vacuum-formed retainer who
consumed five or six soft drinks per day and demonstrated signif-
icant decalcification and caries in normally self-cleansing areas,
such as cusp tips and incisal edges. Sheridan and colleagues [19]

2212-4438/$ e see front matter Ó 2017 World Federation of Orthodontists.

http://dx.doi.org/10.1016/j.ejwf.2017.07.001
128 M. Azeem, W. Ul Hamid / Journal of the World Federation of Orthodontists 6 (2017) 127e130
reported a patient whose incisal edges had demineralised due to
frequent consumption of soft drinks while wearing a plastic sur-
gical splint. A recent study demonstrated that treatment with
removable aligners was associated with improved periodontal
status [20]. Moshiri et al. [17] recommended that aligner patients
with poor oral hygiene should be monitored for the development of
WSLs.
The general assumption is that aligners are hygienic by design,
but following the previously described rationale, it could be spec-
ulated that clear aligner therapy can also lead to development of
new WSLs. There are many studies available regarding the inci-
dence of WSL formation during fixed appliance therapy, but there is
not enough equivalent information concerning incidence of WSLs
during clear aligner therapy. Therefore, the aim of the present study
was to assess the incidence of WSL formation in subjects treated
with clear aligner therapy.
2. Materials and methods
This prospective study was approved by the ethics committee of
our institute. Written informed consents were obtained from the
patients for the publication of this article and any accompanying
images. To calculate estimated sample size, power analysis was
performed using G*-power (version 3.0.10; Franz Faul Universitat,
Kiel, Germany), to reach a power of 0.85, 16 orthodontic subjects
were required, but to allow for dropouts during clear aligner
treatment, the minimum inclusion was set at 25 orthodontic sub-
jects [21,22].
In selecting the sample, we used the following criteria: (1)
comprehensive clear aligner treatment of upper and lower arches,
(2) age 14 to 18 years at the start of aligner therapy, (3) no previous
orthodontic therapy, and (4) no hypodontia. Patients with any
systemic disease, clefts, generalized dental problems, on a daily
supplemental fluoride regimen, or ongoing medication for a
chronic disease were excluded from the study. Patients who already
had WSLs, hypoplastic, or fluorotic enamel in their initial quanti-
tative light-induced fluorescence (QLF) images taken before the
start of the orthodontic treatment were excluded from the study.
Following this, 25 orthodontic patients (12 boys, 13 girls; mean age,
16.17
1.76 years) treated with clear aligner therapy were selected.
All the patients received identical, standardized oral hygiene
instructions, including the advice to brush and floss their teeth at
least three times daily with typical commercially available
1450-ppm toothpastes; otherwise, oral hygiene, nutrition status,
additional fluoride exposure, and saliva differences were not
considered as cofactors in current study. No additional fluoride
applications were given.
The records included each subject’s age, sex, and time points of
start and end of clear aligner therapy. The primary outcome mea-
sures were sound enamel and the numbers of WSLs. For the WSL
assessments, QLF images were taken before and directly after clear
aligner treatment by the same operator using an Inspektor Pro
system (Inspektor Research Systems, Amsterdam, The
Netherlands). Immediately before image capture, the whole quad-
rant was dried. One investigator, who was blinded to the study,
evaluated each image with image-capturing software (C3 v1.20;
Inspektor Research Systems) for signs of decalcification, which
appears as dark areas surrounded by bright green fluorescing sound
tooth tissue, and images were also analyzed for fluorescence loss.
2.1. Statistical analysis
Both tooth-related and patient-related incidences of WSLs were
calculated. Incidence of WSLs was assessed separately for the
maxillary incisors [1,12e21], as well as for tooth groups 15 to 45 and
Table 1
Tooth groups used in the current study
Tooth group No. of Definition by World Dental Federation
teeth numbering system
12e22 4 Maxillary incisors: 22, 21, 11, 12
15e45 20 Maxillary and mandibular incisors, canines, first
and second premolars:
11e15, 21e25, 31e35, 41e45
16e46 24 Maxillary and mandibular incisors, canines, first
and second premolars, and first molars:
11e16, 21e26, 31e36, 41e46
16 to 46 (Table 1). The features of the 25 patients, such as treatment
time and age distribution, were descriptively analyzed. Nonpara-
metric, multifactorial analysis of covariance (ANCOVA) was used for
statistical analysis to assess the impact of the factors “sex” (female,
0; male, 1) and “age group” (16, 0; >16, 1), adjusted by the
covariable “treatment time” on the incidence of WSLs. Overall
fluorescence loss was presented as mean and range and differences
between the tooth groups were analyzed. The Statistical Package for
the Social Sciences (version 20.0; IBM SPSS Statistics, Chicago, IL)
was used for data analysis. P < 0.05 indicated statistical
significance.
3. Results
All patients were considered to be free from WSLs on the smooth
surfaces at baseline, as determined by QLF images. Mean treatment
duration was 18.11
5.12 months (minimum, 8.12 months;
maximum, 26.23 months).
The overall incidence of new WSLs was 2.85% for all the assessed
teeth; 28% of the patients were affected by at least one new WSL,
when all the accessed teeth were considered (Table 2). The patient-
related incidence was 28% for tooth group 16 to 46, or 8% when
considering the maxillary incisors separately (Table 3).
Table 4 shows the results of the ANCOVA of tooth-related WSL
formation in the tooth groups. Frequencies of WSLs were not
significantly different in different age and gender groups; however,
treatment time had a significant impact on WSL formation in tooth
group 12 to 22. Overall fluorescence loss was 5.43%.mm2 (range
0e39.8%.mm2) with insignificant differences between the tooth
groups (P ¼ 0.8). Upper lateral incisors were most affected by WSLs
in the present study.
4. Discussion
Several approaches are available for diagnosis of WSLs [3e7] but
the QLF method was chosen in our study because of its proven
sensitivity and efficiency [21,23,24]. We did not use photographs for
determining the WSL because lighting, angulations, and magnifi-
cation may vary at different time points [25]. Subjects undergoing
clear aligner therapy but already with WSLs on their smooth sur-
faces before the start of treatment, as detected by QLF images, were
excluded from the study, as existing WSLs at baseline seems to be
indicative of increased development of new WSLs.
Table 2
Tooth-related incidences of white spot lesions
Tooth group No. of teeth Incidence, n (% all/male/female)
12e22 90 3 (3.33/3.12/3.76)
15e45 475 11 (2.31/2.12/2.87)
16e46 560 16 (2.85/2.34/2.65)
 M. Azeem, W. Ul Hamid / Journal of the World Federation of Orthodontists 6 (2017) 127e130
Table 3
Patient-related incidences of white spot lesions
Tooth group No. patients Incidence, n (% all/male/female)
12e22 25 2 (8/10.33/8.89)
15e45 25 5 (20/22.87/20.09)
16e46 25 7 (28/29.17/26.88)
The overall incidence of new WSLs was 2.85% for all the assessed
teeth; 28% of the patients were affected by at least one new WSL
when all the accessed teeth were considered. In comparison with
studies on buccal fixed appliance therapy, Enaia et al. [10] found
incidence of WSLs to be 60.9%, Gorelick et al. [26] found the inci-
dence to be 50%, Akin et al. [27] found it to be 55%, and Tufekci et al.
[8] found it to be 46%. Therefore, the current study showed that
aligner therapy makes a difference when WSL incidence is con-
cerned. Development of WSLs with aligner therapy can be related to
findings of Tuncay et al. [28], who demonstrated that aligner pa-
tients may experience accumulation of plaque and mild papillary
bleeding; furthermore, a recent study found that a significant
amount of bacterial plaque remained on the surfaces of aligners
even when proper oral hygiene was performed [29]. Another study
noted that aligner attachments offer further areas of plaque
retention [30]. Results of recent studies showed favorable conse-
quences for periodontal health in patients with aligner therapy
compared with fixed appliance treatment [20,28,31,32]. However,
oral hygiene was not considered as a cofactor in the current study.
The patient-related incidence was 8% when considering the
maxillary incisors separately. In comparison with studies on buccal
fixed appliance therapy, Enaia et al. [10] reported patient-related
WSL incidence of 57% in same tooth group and Tufekci et al. [8]
reported it to be 46% for 13 to 23 tooth group. In the literature,
conflicting reports have described the distribution of WSLs. Gor-
elick et al. [26] and Geiger et al. [33] reported that the tooth most
commonly affected was the maxillary lateral incisor, whereas
Mizrahi [34] and Øgaard [35] found that the first molars were the
teeth most commonly affected. The present study, however, found
no significant differences among teeth in the distribution of WSLs
between tooth groups.
Frequencies of WSLs were not significantly different between
boys and girls, which is in agreement with studies of Mizrahi [36],
Sagarika et al. [37], and Akin et al. [27], but in contrast with findings
of Richter et al. [11], Gorelick et al. [26], Tufekci et al. [8], Boersma
et al. [21], Khalaf [38], and Julien et al. [39], in which gender dif-
ferences were found in development of new WSLs during ortho-
dontic therapy. No gender difference in the present study may be
related to the equal oral hygiene standards in both genders. Simi-
larly, frequencies of WSLs were not significantly different in the two
age groups, which is in agreement with studies of Sagarika et al.
[37], but in contrast to findings of Richter et al. [11], Akin et al. [27],
and Khalaf [38], who showed that age at the start of treatment was
a significant factor in WSL development.
Table 4
Results of the nonparametric analysis of covariance of tooth-related white spot
lesion formation
Variable Incidence of white spot lesions in tooth groups,
P value
12e22 15e45 16e46 17e47
Gender 0.76 0.67 0.83 0.11
Age group 0.64 0.42 0.57 0.49
Gender  age group 0.43 0.06 0.08 0.23
Treatment timings 0.03* 0.56 0.75 0.66
* P < 0.05 indicates statistical significance.
129
Our results showed that treatment time had a significant impact
on WSL formation, especially at the maxillary front teeth. Findings
are in contrast with studies of Chapman et al. [9], Akin et al. [27],
and Al Maaitah et al. [40], but in agreement with findings of Tufekci
et al. [8], Khalaf [38], and Julien et al. [39], who showed that greater
treatment lengths do serve as a risk factor for WSL formation.
Regarding treatment length with aligner therapy, our results
showed that orthodontic treatment using the aligner is comparable
to buccal fixed appliance therapy in terms of treatment length
(18.11
5.12 months).
When comparing the results of the current study with fixed
lingual appliance orthodontic therapy, Wiechmann et al. [41]
showed that 41.95% (28% in current study) developed at least one
new WSL when all teeth were considered, and this incidence was
4.74% for the maxillary incisors. Of all teeth under consideration,
3.19% (2.85% in current study) developed a WSL during treatment.
The patient-related incidence in our study was 8% when consid-
ering the maxillary incisors separately, whereas it was 10.5% in
study by Wiechmann et al. [41].
The variation in WSL incidence among studies could be attrib-
uted to differences in the number of teeth examined, the methods
and standardizations of the examinations, the location of the study
sample, initial age, treatment duration, type of orthodontic therapy,
supplemental fluoride application, and orthodontic materials.
Despite the cost factor that must be weighed against the costs of
prevention or treatment of WSLs, aligner therapy may provide a
fruitful option to patients and orthodontists. The following are
suggestions for WSL prevention during aligner therapy [17]:
 Avoid meals with aligners in mouth
 Brush teeth, and inside of aligner, after every meal
 At night, supplement the normal brushing routine with flossing
and a fluoride mouthwash rinse
 Use an ultrasonic bath or Cleaning System
 Follow-up for professional cleanings and examinations
Limitations of the current study are limited sample size, lack of
blinding, lack of control group and lack of comparison with fixed
appliances. Regardless of these limitations, this study provided data
for incidence of new WSLs during clear aligner therapy. We intend
to use results from the present study to design a future comparative
study with increased sample size.
5. Conclusion
Orthodontic treatment with clear aligner therapy showed a low
incidence of newly developed WSLs. Our suggestion is that clear
aligner therapy should be preferred in orthodontic patients at high
risk of developing WSLs.
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