ORIGINAL ARTICLE

Clinical effect of a fluoride-releasing and

rechargeable primer in reducing white
spot lesions during orthodontic
treatment
Secil Comert and Abdullah Alper Oz
Samsun, Turkey

Introduction: This study was performed to test the long-term efficacy of a highly filled resin primer (38%) that has
superior fluoride release and recharge ability. Methods: Sixty patients were divided into 2 groups. In group 1,
adhesive-coated brackets (APC Plus Victory series, 3M Unitek, Monrovia, Calif) were bonded with a fluoride-
releasing and rechargeable primer (Opal Seal; Ultradent, South Jordan, Utah). In group 2, the same
adhesive-coated brackets were bonded with a conventional primer (Transbond XT Primer; 3M Unitek,
Monrovia, Calif). In group 1, a blacklight source was used to examine the amount of adhesive remaining on
enamel surfaces. This primer has a fluorescing agent and fluoresces under blacklight. If there was a lack of
primer on any part of the enamel surrounding the brackets, new primer was added. Digital images of each
tooth were taken to score and measure the area of white spot lesions (WSLs) after orthodontic treatment.
DIAGNOdent (DIAGNOdent pen; KaVo Dental, Biberach, Germany) measurements were also used to
assess WSLs after bracket removal. Results: The WSL rate was 26.9% for group 1 and 29% for group 2. There
was no significant difference between the WSL scores of the groups; however, a significant difference was
observed in the DIAGNOdent measurements between the groups. According to area measurements of the le-
sions, there was no significant difference between the groups. Conclusions: The results of this long-term clinical
study indicated that fluoride-releasing primer has no significant advantage in reducing demineralization over the
control primer over the full orthodontic treatment period. (Am J Orthod Dentofacial Orthop 2020;157:67-72)

E
namel demineralization, called white spot lesions
(WSLs), is 1 of the most significant risk factors of
orthodontic treatment. When oral hygiene is poor
and there has been prolonged plaque accumulation
around the brackets, protection of the enamel surface
is a challenge for orthodontists.1 The prevalence of these
enamel lesions in patients after fixed orthodontic treat-
ment ranges from 2% to 96%.2-4
Patient education and motivation is the most impor-
tant method for preventing WSL formation. Fluoride
toothpaste, mouth rinses, gels, and varnishes are some
From the Department of Orthodontics, Faculty of Dentistry, Ondokuz Mayıs Uni-
versity, Samsun, Republic of Turkey.
All authors have completed and submitted the ICMJE Form for Disclosure of Po-
tential Conflicts of Interest, and none were reported.
Address correspondence to: Abdullah Alper Oz, Department of Orthodontics,
Faculty of Dentistry, Ondokuz Mayıs University, Atakum, Samsun 55139, Repub-
lic of Turkey; e-mail, alperoz@hotmail.com.
Submitted, May 2018; revised, January 2019; accepted, June 2019.
0889-5406/$36.00
Ó 2019 by the American Association of Orthodontists. All rights reserved.
https://doi.org/10.1016/j.ajodo.2019.06.013
of the other methods of preventing WSLs.5,6 Applying
fluoride to orthodontic bonding agents is also a
popular method.4 In recent years, new adhesives and
primers that contain and release fluoride have entered
the orthodontic market.7,8 Previous studies showed
that these fluoride-containing glass ionomer and com-
posite adhesives decrease enamel decalcification around
orthodontic brackets.9,10 However, the fluoride-
containing and releasing adhesives and primers show
their highest levels during the first weeks after bracket
bonding.11 Therefore, a fluoride-containing material
would not have a significant preventive effect on enamel
demineralization if it was used just once. Fluoride-
releasing materials should be applied repeatedly to in-
crease their effectiveness.5,7
One of the recent primers releases fluoride filled with
38% glass ionomer fillers, coupled with nanofillers for
long-lasting strength (Opal Seal, Ultradent Products,
South Jordan, Utah). This primer also has recharge abil-
ity, and this feature gives the clinician the chance to
apply it repeatedly to increase its effectiveness. However,
67
68
Fig 1. A, The color change and uniform coating of the adhesive; B, Opal Seal fluoresces under black-
light.
the clinical studies about this material are limited and
were only conducted over a few weeks or months after
brackets were bonded to the oral cavity.7,8 The long-
term clinical efficacy of this primer is unclear.
Therefore, the aims of this clinical study were to (1)
compare the WSL prevention effect of this primer and
a conventional one during full orthodontic treatment,
and (2) evaluate the clinical survival of brackets bonded
with Opal Seal and conventional primer.
MATERIAL AND METHODS
Approval was obtained from the Regional Ethics
Committee of Ondokuz Mayıs University for this long-
term clinical study (OMUKAEK 2015/201). Sixty patients
were divided into 2 groups. There were 30 patients in
group 1 with a mean age of 15.8 years and 30 patients
in group 2 with a mean age of 14.9 years. The sample
sizes of the groups were calculated according to a past
study.12 They were selected according to the following
statements: (1) no visible enamel demineralization or
restoration on the buccal surfaces of the teeth, (2) no
morphologic crown anomalies, (3) permanent dentition,
and (4) no physical disability preventing effective tooth
brushing.
Special care was taken to include patients with similar
characteristics in both groups. Age, sex distribution,
amount of crowding, number of patients who needed
extraction for orthodontic treatment, salivary flow, and
buffer capacity of the patients were determined to estab-
lish any differences between the groups before the or-
thodontic treatment. All patients had normal salivary
flow rates (.1.0 mL/min) and normal pH measurements
(6.7-7.7).
In both groups, all teeth had been cleaned and pol-
ished before the fixed appliances were bonded. There-
after, the teeth were acid-etched with 32% phosphoric
acid (Scotchbond Universal Etchant, 3M Dental
January 2020  Vol 157  Issue 1 American Journal of Orthodontics and Dentofacial Orthopedics
Comert and Oz
Products, Germany) for 15 seconds, rinsed, and dried.
In group 1, a thin layer of Opal Seal primer was applied
to the etched enamel surface. Before bracket bonding,
the primer was cured for 5 seconds with a light-
emitting diode unit (Elipar S10; 3M Unitek, Monrovia,
Calif). Adhesive-coated brackets (APC Plus Victory series,
3M Unitek, Monrovia, Calif) were used for all patients.
The adhesive remaining around the bracket margins
was removed, and all bonding procedures were per-
formed by the same investigator (S.C.). The patients
were recalled every 4 weeks during the orthodontic
treatment. This primer was designed for re-application
during orthodontic treatment. Opal Seal has a fluo-
rescing agent and fluoresces under blacklight. Shining
a UV blacklight on the enamel surface will indicate the
presence of the sealant (Fig 1). If there was a lack of
primer on any part of the enamel surrounding the
brackets, new primer was added.
In group 2, a conventional primer (Transbond XT
Primer; 3M Unitek, Monrovia, Calif) was applied to the
etched enamel surfaces. The same adhesive-coated
brackets were bonded, too. These adhesive-coated
brackets have a pink, color-changing adhesive. This co-
lor change and uniform coating of adhesive on each
tooth allows easy flash clean-up.
The same investigator gave brushing training and
oral hygiene instructions to the patients in both groups.
The patients were reminded of these suggestions if their
oral hygiene motivation decreased during the orthodon-
tic treatment.
After the fixed orthodontic appliances had been
removed, and adhesive remaining on enamel surfaces
was cleaned with a tungsten carbide burr. Digital im-
ages of each tooth were taken to score and measure
the area of WSLs before and after orthodontic treat-
ment (EOS 600D, Canon Macro Ring Lite MR-14EX
flash, 100 mm f: 2.8 macro lens; Canon, Tokyo, Japan).
Comert and Oz 69

Fig 2. Digital images of each tooth were taken to score and measure the area of WSLs.

All photographs were taken directly without a mirror

(Fig 2).
All separate digital images were examined, and the
presence and severity of WSLs were recorded according
to a modified WSL scoring system as follows: (0) no
WSLs, (1) slight WSLs, (2) severe WSL formation, (3)
WSLs with cavitation.2
After the fixed orthodontic attachments had been
removed, the buccal surfaces of the teeth in both groups
were dried and then measured with a DIAGNOdent de-
vice (DIAGNOdent pen; KaVo Dental, Biberach, Ger-
many). The buccal probe was used; every tooth was
tested twice, and the mean value was recorded. Scores
of 0-12 show normal and healthy enamel, 13-24 suggest
incipient caries, and 25 or above indicate dental caries.
The areas of the WSLs were also measured. For this
purpose, mesiodistal lengths of the teeth with WSLs Fig 3. The areas of WSLs were calculated with the soft-
were measured from orthodontic models, and images ware.
were scaled according to these measurements. The areas
were calculated by open source software (ImageJ,
RESULTS
version 2.0, National Institutes of Health, Bethesda,
Md) (Fig 3). The distributions of the sample characteristics of the
The patients were recalled every 4 weeks during the groups are given in Table I. The patients were similar in
orthodontic treatment for a routine appointment, and the 2 groups, and there was no significant difference in
the clinical failure rates were recorded. Only first-time patients' ages, amount of crowding, duration of treat-
bracket failures were recorded. New brackets were ment, salivary flow, or buffer capacity (Table I). After
bonded with the same bonding protocols as used at the fixed orthodontic treatment, 305 of the 1090 teeth
the beginning of the treatment according to the investi- showed WSLs according to the digital images. The
gation groups. However, new brackets were not included WSL rate was 26.9% for the Opal Seal group and 29%
in the bond failure part of the study. for the control group. There was no significant differ-
Two patients in each group did not attend the ap- ence between the WSL rates of the groups.
pointments regularly during the orthodontic treatment, Table II shows the WSL scores and comparison of the
and the final data were analyzed with 28 participants per groups according to severity of the lesions in the digital
group. All the statistical analysis was performed using photographs. There was also no significant difference
SPSS statistical software (version 23; IBM, Chicago, Ill). between the groups (P . 0.05). However, a significant
The paired sample t test and Mann-Whitney U test difference was observed in the DIAGNOdent measure-
were used according to the distribution of the data. Cat- ments between the groups (Table III). According to these
egorical data were assessed using Pearson chi-square measurements, the Opal Seal group showed fewer WSLs
test. Differences in bracket survival according to primer than the Transbond group. The number of initial demin-
type, patient's sex, and dental arch and tooth type eralization was 7 (1.3%) for group 1 and 21 (3.9%) for
were evaluated with Kaplan-Meier and log-rank tests. group 2. There was only 1 (0.2%) caries lesion in group
The level of significance was set at P \ 0.05. 1, whereas there were 7 (1.3%) in group 2.

American Journal of Orthodontics and Dentofacial Orthopedics January 2020  Vol 157  Issue 1
70 Comert and Oz

Table I. The distributions and comparisons of the sample characteristics of the groups
Characteristics Opal Transbond Test statistics (t) P
Age (y) 15.89 6 2.86 14.96 6 1.43 1538 0.132
Treatment duration (mo) 12.82 6 3.53 13.75 6 4.77 –0.828 0.411
Amount of crowding (maxillary) 3.9 6 1.83 3.71 6 1.64 0.415 0.679
Amount of crowding (mandibular) 3.03 6 1.6 2.82 6 1.56 0.482 0.632
Salivary pH 6.99 6 0.18 7.01 6 0.22 –0.468 0.642
Salivary flow rate (mL/dk) .1 .1

Table II. Visual assessment of presence and severity of WSLs and comparison of the scores
WSL scoring Opal, n (%) Transbond, n (%) Test statistics (c2)* P
No WSLs (0) 399 (73.1) 386 (71) 5.416 0.144
Slight WSLs (1) 125 (22.9) 121 (22.2)
Severe WSLs formation (2) 18 (3.3) 25 (4.6)
WSLs with cavitation (4) 4 (0.7) 12 (2.2)

*Pearson chi-square test.

Table III. DiagnoDENT measurement scores according
to the groups and statistical comparison
Test
DiagnoDENT results Opal Transbond statistics
Healthy enamel 538 (98.5) 516 (94.9) 11.956
(score 0-12)
Incipient caries 7 (1.3) 21 (3.9)
(score 13-24)
Dental caries 1 (0.2) 7 (1.3)
(score .24)
No significant difference was observed in the WSL
area between the 2 groups. The mean WSL area was
1 6 1.3 mm2 in group 1 and 1.3 6 1.2 mm2 in group
2 (Table IV). No significant difference was observed in
the bracket failure rates between the primers, dental
arches, bracket types, or sexes (Table V).
DISCUSSION
Although the main factor for white spot formation is
insufficient oral hygiene and prolonged plague accumu-
lation, some individual factors such as the age of the pa-
tients at the start of the treatment,13 duration of the
treatment, and percentage of treatment time in elasto-
meric chain may also be effective factors in the forma-
tion of WSLs.14 In the present study, the authors
compared those factors, and there was no significant
difference in age at the beginning of the orthodontic
treatment, treatment duration, amount of crowding,
and so on, between the groups.
A split-mouth design could eliminate individual dif-
ferences such as oral hygiene, saliva pH, and diet and
Table IV. WSL area measurements and comparison of
the 2 groups
Median Test
P Group Mean 6 SD (min-max) statistics (U)* P
0.003 Opal 1 6 1.3 0.7 (0.2-4.6) 294.5 0.431
Transbond 1.3 6 1.2 0.8 (0.3-8.5)
*Mann-Whitney U test.
allow each patient to be their own control. However,
some past studies have highlighted the disadvantages
of this method during the investigation of fluoride-
releasing materials in the oral environment.15,16 It was
emphasized that there is a possibility of cross
contamination from 1 side to another. Therefore,
authors avoided using a split-mouth design and tried
to create 2 different groups with similar features.
The first and most effective method in preventing
WSL formation is patient education and cooperation.
There are also some auxiliary methods such as profes-
sional regular cleaning; fluoride administration mouth
rinses, gels, and toothpastes; and fluoride-containing
bonding agents.6,17 In the 1980s, glass ionomer
cements were proposed for fluoride releasing and
development of a less cariogenic microflora.11 However,
the bond strengths of those materials have limited their
clinical usage.18 Fluoride-containing composites or
compomers were developed for this reason, but they
showed their highest levels of fluoride release during
the first few days after the first application.11 Thus, to in-
crease the effect of those fluoride-releasing bonding
materials, they should be applied repeatedly.

January 2020  Vol 157  Issue 1 American Journal of Orthodontics and Dentofacial Orthopedics
Comert and Oz
Table V. Distribution of the bracket failure rates
Evaluated parameters Number Bracket failure Censored
Primer
Opal 544 9 535
Transbond 546 12
Dental arch
Maxillary 544 10
Mandibular 546 11
Bracket type
Anterior 448 9 439
Canine 224 1 223
Premolar 418 11
Sex
Female 718 16
Male 372 5 367
NS, Not significant (not statistically significant, P. 0.05).
Opal Seal primer illuminates under blacklight if there
is still fluoride in it. A past study showed that 50% of the
Opal Seal was removed from the enamel surface after 8
weeks.7 In the present study, the authors did not eval-
uate the primer loss percentage. However, in every
4 weeks, authors used blacklight, and if there was primer
loss, they added new primer and recharged it.
In this long-term clinical study, the authors tested the
efficacy of a fluoride-releasing and rechargeable primer
in reducing WSLs. Although some short-term clinical
studies are available in the orthodontic literature about
this material, there is no certain evidence about long-
term usage. T€ ufekçi et al7 and Oz et al8 indicated no sig-
nificant difference between the efficacies of the same
primer that was used and the control primer in reducing
demineralization over the duration of their studies. In
the present study, visual evaluation with a modified
WSL scoring system showed results similar to those of
past studies. According to the visual evaluation of pho-
tographs with magnification, the authors found no sig-
nificant difference between the WSL scores of the
groups, and WSLs were found in considerable amounts
at the end of the orthodontic treatment. However, ac-
cording to the DIAGNOdent measurements, the Opal
Seal group showed less enamel demineralization after
the orthodontic treatment.
There are some in-vivo assessment methods for
determining demineralization of enamel surfaces. Clin-
ical examination, quantitative light-induced fluores-
cence,19 fiber-optic transillumination, electronic caries
monitor, and combinations of these methods were
used in previous studies.20 Although DIAGNOdent was
also used in past studies, some other studies demon-
strated that it yielded no better results than visual in-
spection in the precavitated stage.20,21 The result of
American Journal of Orthodontics and Dentofacial Orthopedics
71
Censored (%) Failure rate (%) Log-rank
98.3 1.7 NS
534 97.9 2.1
534 98.1 1.9 NS
535 98 2
97.9 2.1 NS
99.5 0.5
407 97.3 2.7
702 97.7 2.3 NS
98 2
the current study supports this opinion. Furthermore,
the results of visual and DIAGNOdent evaluations did
not match each other. The visual evaluation did not
show any difference between the 2 primers, but
DIAGNOdent measurements showed a significant
difference between the groups. In the present study,
the visual examination was conducted using
photographs under magnification. This procedure gives
a chance to identify very small lesions that cannot be
seen in clinical inspections. Hence, the rate of WSLs in
the photographic examination under magnification
was higher than that of the DIAGNOdent results.
There are some bonding materials that reduce the
incidence of enamel decalcification around the brackets,
but their failure rate was higher than that in the control
groups, and their bonding performance may not be
acceptable for clinicians.22,23 Thus, bracket failure rate
is also an important factor for clinicians when deciding
on which materials to use. In the present study, there
was no significant difference in the bracket failure rate
between the groups. The failure rate was not high
when compared with past studies, and both primers
can be used safely during bracket bonding.22
CONCLUSIONS
There was no significant difference between the
fluoride-releasing and rechargeable primer and the con-
trol primer when it was used repeatedly during ortho-
dontic treatment. The areas of the lesions were not
significantly different. No significant differences in clin-
ical failure rates were found between the groups either.
The findings regarding visual assessment with photo-
graphs measurements indicate that the Opal Seal primer
did not show any superiority to the conventional primer
in preventing WSLs. There were also substantial numbers
January 2020  Vol 157  Issue 1
72
of WSLs in both groups, and so optimum oral hygiene is
still the most effective method to protect the enamel sur-
face during fixed orthodontic therapy.
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