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ORIGINAL ARTICLE

Effect of light-curable uoride varnish on enamel


demineralization adjacent to orthodontic
brackets: An in-vivo study
Anurag Mehta,a Ganesh Paramshivam,b Vinay Kumar Chugh,c Surjit Singh,d Sudha Halkai,e and Santosh Kumarf
Jodhpur, Rajasthan, Bengaluru and Gulbarga, Karnataka, and Moradabad, Uttar Pradesh, India

Introduction: The purpose of this in-vivo study was to evaluate the effect of a single application of Clinpro XT
(3M ESPE, Pymble, New South Wales, Australia), a light-curable uoride varnish, on enamel demineralization
adjacent to orthodontic brackets. Methods: Thirty-eight patients (152 teeth) whose orthodontic treatment
involved extraction of 4 rst premolars were recruited. Two premolars each were assigned to the control group
(no treatment) and the experimental group (received uoride varnish application). The study was designed as a
nonrandomized split-mouth study in which diagonally opposite quadrants received the same treatment. After the
bonding procedures, a sectional T-loop was ligated into each bracket to serve as a site for plaque retention for
enhanced demineralization. Clinpro XT was applied on the buccal surfaces adjacent to the brackets on all teeth
in the experimental group only. Teeth in both groups were extracted after 15 days (n 5 30), 30 days (n 5 30),
45 days (n 5 30), 90 days (n 5 18), and 120 days (n 5 18). Buccolingual sections were then evaluated
under polarized light microscopy. After we excluded the dropouts, the mean depth of the demineralized
enamel lesions was measured in nal sample of 126 teeth. The Mann-Whitney test was used for comparison
of the groups. Results: In the control group, the depths of the demineralized enamel lesions increased from
30 to 120 days, whereas in the experimental group no sign of demineralization was noted throughout the observation period except for 3 teeth. Signicant differences in the depths of demineralized lesions were found between the study groups. Conclusions: Clinpro XT light-curable uoride varnish may be a reasonable
alternative in the reduction of enamel demineralization around orthodontic brackets, especially in
noncompliant and high-risk patients. (Am J Orthod Dentofacial Orthop 2015;148:814-20)

namel demineralization around xed orthodontic


appliances remains the most concerning aspect of
xed appliance therapy. The complex structure of
orthodontic brackets makes their periphery an amenable

a
Senior lecturer, Department of Orthodontics and Dentofacial Orthopedics, Vyas
Dental College and Hospital, Jodhpur, Rajasthan, India.
b
Private practice, Bengaluru, Karnataka, India.
c
Associate professor, Department of Orthodontics and Dentofacial Orthopedics,
Vyas Dental College and Hospital, Jodhpur, Rajasthan, India.
d
Assistant professor, Department of Pharmacology, All India Institute of Medical
Sciences, Jodhpur, Rajasthan, India.
e
Senior lecturer, Department of Orthodontics and Dentofacial Orthopedics,
Hyderabad Karnataka Education Society, S Nijalingappa Dental College, Gulbarga, Karnataka, India.
f
Reader, Department of Orthodontics and Dentofacial Orthopedics, Kothiwal
Dental College and Hospital, Moradabad, Uttar Pradesh, India.
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conicts of Interest, and none were reported.
Address correspondence to: Vinay Kumar Chugh, Department of Orthodontics
and Dentofacial Orthopedics, Vyas Dental College & Hospital, Pali Road, Kudi
Haud, Jodhpur, 342005 Rajasthan, India; e-mail, drvinaychd@yahoo.com.
Submitted, November 2014; revised and accepted, May 2015.
0889-5406/$36.00
Copyright 2015 by the American Association of Orthodontists.
http://dx.doi.org/10.1016/j.ajodo.2015.05.022

site for the retention of bacterial plaque and hence a potential risk for enamel demineralization. The prevalence
of enamel demineralization after xed orthodontic
appliance placement includes up to 50% of patients
when no preventive uoride programs were used.1
Fluorides have long played a critical role in the prevention of enamel demineralization during orthodontic treatment. Topical uorides have been used extensively in the
prevention of enamel demineralization around orthodontic brackets.2 Geiger et al3 reported a 25% reduction in the
number of patients with white spot lesions when they
used a home uoride rinsing program. Stratemann and
Shannon4 found that only 2% of patients on a uoride
regimen developed white spot lesions, whereas 58% of
patients without uoride developed lesions. Nevertheless,
the effectiveness of these products is directly related to
patient compliance. The difculty achieving full compliance with a uoride regimen warrants noncompliance
methods with good clinical efcacy.
Fluoride-releasing composites and glass ionomer
cements have addressed this problem to some extent,
but the bond strength of these materials is lower than

814

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Mehta et al

815

conventional composite resin and less than ideal for


clinical treatment.5,6 Fluoride varnishes are easy to use
and do not depend on patient cooperation. The role of
conventional uoride varnishes has been established in
both in-vitro7-9 and in-vivo10,11 studies. However, the
longevity and sustainability of these coatings are
questionable; therefore, they require repeated
applications at specic intervals; this is a cumbersome
procedure.12
Clinpro XT (3M ESPE, Pymble, New South Wales,
Australia) is a highly lled, resin-modied glass
ionomer-based light-curable uoride varnish (LCFV).
The varnish layer is claimed to remain intact for more
than 5000 brushing strokes and can resist toothbrush
abrasion and normal wear for 6 months or longer. The
effectiveness of Clinpro XT varnish has been investigated
for dentinal hypersensitivity13 and remineralization,14
but its role in the reduction of enamel demineralization
around orthodontic appliances is not entirely clear.
Therefore, the prime objective of this in-vivo study was
to evaluate the effect of a single application of Clinpro
XT on enamel demineralization adjacent to orthodontic
brackets during xed orthodontic treatment.
MATERIAL AND METHODS

This research was designed as a prospective clinical


study. Thirty-eight patients aged between 13 and
21 years (mean age, 15.5 years) whose orthodontic treatment involved extraction of 4 rst premolars were
initially recruited in the orthodontic clinic of Hyderabad
Karnataka Education Society, S Nijalingappa Dental
College, Gulbarga, Karnataka, India. The sample size
was determined using the data for m1, m2, and s from
the study of Schmit et al.15 Assuming a statistical power
of 90% and an alpha error of 5%, a minimum of 7 teeth
per time period (15, 30, 45, 90, and 120 days) would be
necessary in each group. Considering dropouts (we expected 20% to be lost to follow-up), at least 9 teeth
per time period in each group were required. To increase
the power of the study, a few more were included. The
research was approved by the research and ethical committee of our institution.
The inclusion criteria were (1) subjects who consented to all rst premolar extractions, (2) all rst premolars fully erupted with an intact buccal surface, and
(3) no rst premolars with clinical evidence of demineralized lesions and uorosis. We explained the specics of
the study to all subjects, and informed consent was
obtained from each subject.
The study was designed so that in each patient the rst
premolars were allocated to one of the following treatment groups: control group (received no treatment) and

Fig 1. T-loop design used in this study.

experimental group (received uoride varnish application). We used a nonrandomized split-mouth design in
which one quadrant received uoride varnish application,
and the opposite quadrant received no application. The
diagonally opposite quadrant received the same treatment. Every alternate patient received the same application pattern in the respective quadrants. Since every
patient received varnish application in 2 diagonally opposite quadrants, with no varnish application in the other
2 diagonally opposite quadrants, each patient served his
or her own control; hence, the benet of randomization
was achieved through the split-mouth design. This distribution allowed the same environment for all teeth.
After cleaning the teeth with nonuoridated pumice
paste, etching of the enamel surfaces was done with
37% o-phosphoric acid. Standard stainless steel preadjusted edgewise brackets were bonded to the center of
teeth with nonuoridated light-cured composite resin
and conventional primer. T-loops of a uniform dimension (0.16 3 0.25-in stainless steel) were ligated to the
brackets with elastomeric rings to simulate the clinical
situation (Fig 1).
In the experimental group, Clinpro XT was applied
on the buccal surfaces surrounding the brackets and
then light cured for 1 minute according to the manufacturers instructions. All patients were instructed not
to brush their teeth for up to 6 hours. Routine oral
hygiene instructions were given to each patient to
maintain satisfactory oral hygiene, and nonuoridated
toothpaste was advised until the collection of the
samples.
At the end of each time period (15, 30, 45, 90, and
120 days), brackets were debonded and the premolars
extracted (Table). A careful debonding procedure was
used to ensure that there were no enamel microfractures
around the bracket bases. The roots of all the teeth were
cleaned and stored in 0.1% thymol solution. The teeth
were embedded in a mold with chemically cured resin
to prevent fracturing during thickness reduction.

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Mehta et al

816

Table. Descriptive statistics and results of statistical analysis for comparison of enamel lesion depths among the study

groups
Median*
15 days
Control (n 5 15)
Experimental (n 5 15)
30 days
Control (n 5 15)
Experimental (n 5 15)
45 days
Control (n 5 15)
Experimental (n 5 15)
90 days
Control (n 5 9)
Experimental (n 5 9)
120 days
Control (n 5 9)
Experimental (n 5 9)

Minimum

Maximum

Mean*

SD

P value
.0.99

0.00
0.00

0.00
0.00

0.00
0.00

0.00
0.00

0.00
0.00

0.000

40.60
0.00

35
0.00

45
0.00

40.2
0.00

2.89
0.00

4.988

0.000y

62.73
0.00

60
0.00

70
0.00

63.7
00

3.39
0.00

4.987

0.000y

127.70
0.00

126
0.00

151
58

130.5
10.6

7.85
21.69

3.686

0.000y

217.10
0.00

160
0.00

260
60

209.4
6.63

34.42
19.9

3.742

0.000y

*Depth in mm; yP\0.001; comparison of lesion depths between control and experimental groups with the Mann-Whitney test; P\0.05 was considered to be signicant.

xylene as the imbibed medium. Polarized light enables


differentiation of enamel lesions in different colors.
Microphotographs of the gingival half of the buccal
surface were taken with xed magnication of 25 times.
In each section, the gingival, middle, and occlusal areas
of the demineralized enamel lesions were measured with
a scale in the same magnication. The average of these 3
measurements was recorded as the lesion depth for that
section (Fig 2). This process was repeated 3 times by
2 oral pathologists in a blinded situation.
Statistical analysis

Statistical analysis was performed using SPSS statistical package for Windows (version 21; IBM, Armonk,
NY). Normality testing was done with the KolmogorovSmirnov test. The Mann-Whitney test was used to
compare the groups. The statistical signicance level
was established at P \0.05.
RESULTS

Fig 2. Method used to record depth of demineralized


enamel lesion.

Buccolingual sections were made in the middle third of


the crown using a hard tissue microtome (SP1600; Leica,
Nussloch, Germany). The thickness of each section was
further reduced to 50 to 70 mm by hand grinding. Teeth
damaged during the sectioning procedure were discarded. The sections were evaluated under polarized
light microscopy (BX51; Olympus, Tokyo, Japan) with

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Thirty-six patients (144 teeth) fullled the inclusion


criteria and actually became part of the trial. Of the 36
patients, 3 (12 teeth) were lost to follow-up, and 6 premolars were damaged during the sectioning procedure.
A total of 126 teeth, dispersed among 5 time periods,
were equally divided among the control and experimental groups and were evaluated for enamel demineralization (Fig 3).
The mean depths, standard deviations, medians, and
minimum and maximum measurements of the lesions in
each group are given in the Table. No demineralized
enamel lesion was found until 15 days in either group.

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Mehta et al

817

Paents with first premolar extracons (38),


total teeth n = 152
Paents declined informed consent (2),
teeth excluded n = 8
Paents divided into 2 groups (36),
teeth n = 144
Experimental teeth (n = 71)
(Received varnish applicaon)

Control teeth (n= 73)


(No treatment)

Teeth at 15 days (n= 15)

Teeth at 15 days (n= 15)

Teeth at 30 days (n= 15)

Teeth at 30 days (n= 15)

Teeth at 45 days (n= 15)

Teeth at 45 days (n= 15)


Teeth damaged (n = 4)

Paent Lost to follow up = 2 (Teeth n = 8)


Teeth damaged (n = 2)
Teeth at 90 days (n= 9)

Teeth at 90 days (n= 9)


Paent Lost to follow up = 1
(Teeth n = 4)

Teeth at 120 days (n= 9)

Teeth at 120 days (n= 9)

Fig 3. CONSORT diagram showing the ow of participants through each stage of the clinical trial.

Fig 4. Polarized light microphotograph of demineralized


enamel lesion adjacent to bracket surface that did not
receive uoride varnish treatment (enamel surface layer
was lost).

Demineralization was observed at the end of 30 days in


the control group. The mean demineralized enamel
lesion depths for the control group at 30, 45, 90, and
120 days were 40.17 6 2.79, 59.71 6 70.46,
126.2 6 151.1, and 159.6 6 259.9 mm, respectively. In
the experimental group (varnish application), no demineralized enamel lesion was found during the study period
except for 3 teeth (2 after 90 days, 1 after 120 days). The

majority of data were normally distributed according to


the Kolmogorov-Smirnov test, but some data did not
conform to a normal distribution; therefore, a nonparametric test was performed. The Mann-Whitney test
showed signicant differences (P \0.001) between the
control and experimental groups regarding demineralized enamel lesion depths (Table).
Figures 4 and 5 are microphotographs of
representative samples from the control group (after
90 days) and the experimental group (after 120 days).
Figure 4 depicts the break in continuity of the enamel
layer. In Figure 5, the effect of the LCFV can be clearly
seen, because the surface layer of enamel seems to be
intact even after 120 days.
DISCUSSION

The use of uoride varnish is continuously being


investigated in search of an effective preventive means
for white spots lesions, especially for ease of professional
application in long-term clinical situations. The role of
uoride varnish in inhibiting enamel demineralization around xed appliances is increasingly being
accepted.8,9,16 In our study, the effect of LCFV was
observed for a period of 4 months. The 15, 30, 45, 90,
and 120 days duration of this study permitted
evaluation of demineralization without interfering with

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Mehta et al

818

Fig 5. Polarized light microphotograph of demineralized


enamel lesion adjacent to bracket surface that received
LCFV application (enamel surface layer intact).

the treatment process. The distinctness of this in-vivo


study was that the oral environment simulated what is
routinely encountered in clinical settings. Elastic ties
and loops used in this study are often incorporated during treatment with xed appliances.
At the end of 15 days, no sign of enamel demineralization was observed on any exposed labial surfaces in
either group. This also supports earlier studies that white
spot lesions develop in only 1 month around orthodontic
appliances.17 In the control group, demineralized lesions
began to appear after 30 days, and increased enamel
lesion depth was observed from 30 to 120 days; however, no sign of hypersensitivity or toxicity was reported.
The interesting nding of this study was that no demineralized enamel lesion was seen during the study period
in the experimental (varnish) group except for 2 teeth in
the 90-day group and 1 tooth in the 120-day group.
To best of our knowledge, no in-vivo study has yet
evaluated enamel demineralization with LCFV for a
period of 4 months. The closest in-vivo study to ours
was one by Farhadian et al,11 who evaluated the effect
of a high-concentration uoride varnish (Biuoride 12)
on enamel demineralization adjacent to bonded
brackets. Brackets were debonded 85 to 95 days after
the uoride varnish application. The results suggested
that 1 application of uoride varnish can decrease
enamel lesion depth adjacent to bonded brackets by
about 40% for 3 months. The results were promising,
but to maximize its effect, frequent applications of
uoride are required. In our study, the mean lesion
depths were 10.6 mm in the experimental group and
130.5 mm in the control group after 90 days. Thus, it
can be inferred that that 1 application of LCFV provides
90% to 100% protection even after 3 months.

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The use of chemically cured and light-cured sealants


has also been advocated to prevent enamel demineralization around orthodontic brackets. The difculty with
chemically cured sealants is that they do not effectively
and smoothly seal to the enamel surface because of
oxygen inhibition of polymerization.18-20 Light-cured
sealants have had some success in in-vitro studies, but
in-vivo studies have demonstrated that the light-cured
unlled resin does not provide more protection than
chemically cured sealants.10 This means that retention
on the tooth surface is an important factor in selecting a
uoride delivery method. Clinpro XT, because it is lightcured, is advantageous; moreover, its high ller content
imparts wear resistance that can resist up to 5000 strokes
of brushing (according to the manufacturers claim; 3M
ESPE Internal Data, www.3MESPE.com.au) before being
mechanically deformed.
The dosage of uoride necessary for protection
against enamel demineralization has been a matter of
debate among various investigators. Basdra et al21 in
an in-vitro study reported that uoride agents that
release a high dose of uoride initially (burst effect)
would be more effective in increasing enamel resistance
to demineralization. Contrary to this, Linton22 showed
that a low concentration of uoride (50 ppm) is more
effective in enamel remineralization than a high dose
(225 ppm), because the latter physically blocks the surface layer from penetrating calcium ions to subsurface
layers.23 It seems that high doses of uoride are useful
in inhibiting lesion formation, and low doses are effective in remineralization and controlling the progress of
the lesions.24 In-vitro testing (3M ESPE Internal Data;
www.3MESP.com.au) has shown that Clinpro XT offers
protection through more uoride release in both the
short term (releases more uoride over a 24-hour period)
and the long term (over 6 months longer than other
coatings). Within the ambit of this study, these claims
could not be veried, and future histologic studies
must be conducted to verify them.
Repeated applications of uoride varnish have often
been recommended to maintain its caries preventive
effect.25 Various clinical regimens for conventional uoride varnish application have been suggested to reduce
carious lesion depth. It may be one application per
year,26 a semiannual application,27 4 application per
year,28 or 3 applications per week for 3 to 4 years.29,30
Monthly applications of uoride varnish have also
been proposed for orthodontic patients with a high
risk for developing white spot lesions, or those who
already have them.15 However, no study has investigated
the effect of LCFV on enamel demineralization and its
frequency of application.

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Mehta et al

819

The results of a recent systematic review showed


some moderate evidence that uoride varnish applied
every 6 weeks during orthodontic treatment is effective.31 If the average orthodontic treatment duration is
assumed to be 2 years, then conventional uoride varnishes could require 16 to 24 applications during the
treatment to achieve almost complete protection. This
study offers some evidence that LCFV can provide protection for up to 4 months or even longer, and may
reduce the frequency to 4 to 6 applications in a 2-year
treatment. The frequency of applications seems to
decrease by almost threefold with LCFV; this is signicant, and hence this effect should be considered.
As previously mentioned, 3 teeth (2 in the 90-day
group, 1 in the 120-day group) in the experimental
group had detectable lesions. A possible cause for areas
of demineralization may be entrapment of small air bubbles beneath the varnish surface. These bubbles were not
visually detectable when examined, and the resulting
white spots were difcult to identify without magnication. In a clinical setting, these lesions might not be
noticed by the patient or even by the doctor except
with careful and deliberate examination.
Our study does not suggest that LCFV application is
superior to uoride rinses and gels, uoridated dentifrices, sealants, or any other caries-preventive measure.
It merely provides an alternative way to deal with the
problem of the development of white spot lesions during
active orthodontic treatment, particularly in noncompliant and high-risk patients. The disadvantage of the
increased chairside time raises some concerns, but the
benets surely appear to be far more convincing.
Although these results are encouraging, they should be
interpreted with caution. In the future, in-vivo studies,
perhaps with complete randomization and a larger
sample size should be undertaken to examine the
efcacy and side effects (if any) of this varnish in preventing enamel demineralization around orthodontic
appliances.
CONCLUSIONS

On the basis of this in-vivo study, the following conclusions were made.
1

In the control group (no treatment), the depths of


the demineralized enamel lesions increased from
30 to 120 days, whereas in the experimental group
(uoride varnish application) no sign of demineralization was noted during the observation period
except for 3 teeth (2 in 90-day group, 1 in 120day group).
Signicant differences in the depths of demineralized lesions were reported between the control and

experimental groups at the end of 30, 45, 90, and


120 days, respectively.
A single application of Clinpro XT, an LCFV, can prevent demineralization in long-term clinical situations up to 120 days and may be a useful
alternative in noncompliant and high-risk patients.

ACKNOWLEDGMENTS

We thank the Department of Oral Pathology, College


of Dental Sciences, Davangere, Rajiv Gandhi University
of Health Sciences, Bengaluru, Karnataka, India, for
helping us in preparing and evaluating in histologic sections and 3M Unitek Division, India, for providing help
during the research.
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