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)
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
Mehta et al
815
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.
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.
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
Mehta et al
817
Fig 3. CONSORT diagram showing the ow of participants through each stage of the clinical trial.
Mehta et al
818
Mehta et al
819
On the basis of this in-vivo study, the following conclusions were made.
1
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Mehta et al
820
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