Original Paper

Caries Res 2007;41:455459

DOI: 10.1159/000107932

Received: January 31, 2007

Accepted after revision: March 19, 2007
Published online: September 7, 2007

Caries-Preventive Effectiveness of a Fluoride

Varnish: A Randomized Controlled Trial in
Adolescents with Fixed Orthodontic Appliances
C. Stecksn-Blicks a G. Renfors b N.D. Oscarson b F. Bergstrand c S. Twetman d
a

Department of Odontology, Paediatric Dentistry, Faculty of Medicine, Ume University, Ume,

Public Orthodontic Clinics, Lycksele and Skellefte, and c City Clinic in Orthodontics, Stockholm, Sweden;
d
Department of Cariology and Endodontics, Faculty of Health Sciences, University of Copenhagen, Copenhagen,
Denmark
b

Key Words
Enamel demineralization  Fixed appliances  Fluoride
varnish  Orthodontics

Abstract
The aim was to evaluate the efficacy of topical fluoride varnish applications on white spot lesion (WSL) formation in
adolescents during treatment with fixed orthodontic appliances. The study design was a double-blinded randomized
placebo-controlled trial with two parallel arms. The subjects
were 273 consecutive 12- to 15-year-old children referred for
maxillary treatment with fixed orthodontic appliances. The
patients were randomly assigned to a test or a control group
with topical applications of either a fluoride varnish (Fluor
Protector) or a placebo varnish every 6th week during the
treatment period. The outcome measures at debonding
were incidence and progression of WSL on the upper incisors, cuspids and premolars as scored from digital photographs by 2 independent examiners. The attrition rate was
5%. The mean number of varnish applications was 10 (range
420) in both groups. The incidence of WSL during the treatment with fixed appliances was 7.4% in the fluoride varnish
compared to 25.3% placebo group (p ! 0.001). The mean
progression score was significantly lower in the fluoride varnish group than in the placebo group, 0.8 8 2.0 vs. 2.6 8 2.8
(p ! 0.001). The absolute risk reduction was 18% and the

2007 S. Karger AG, Basel

00086568/07/04160455$23.50/0
Fax +41 61 306 12 34
E-Mail karger@karger.ch
www.karger.com

Accessible online at:

www.karger.com/cre

number needed to treat was calculated to 5.5. The results

from the present study strongly suggest that regular topical
fluoride varnish applications during treatment with fixed appliances may reduce the development of WSL adjacent to
the bracket base. Application of fluoride varnish should be
advocated as a routine measure in orthodontic practice.
Copyright 2007 S. Karger AG, Basel

Professional application of fluoride varnish has a

strong tradition in many European countries and the
therapy is often advocated as a supplement for individuals at caries risk [Helfenstein and Steiner, 1994; Sepp,
1999; Petersson et al., 2004; ADA Council on Scientific
Affairs, 2006]. Adolescents treated with fixed orthodontic appliances may be considered as a risk group due to
the accumulation of dental plaque, and the incidence of
early enamel demineralization (white spot lesions, WSL)
adjacent to the brackets has been estimated to be 15
85% [Mitchell, 1992]. As this could jeopardize the final
aesthetic result, the potential of fluoride varnish in WSL
prevention has been evaluated in vitro [Adriens et al.,
1990; van der Linden and Dermaut, 1998; Todd et al.,
1999; Schmit et al., 2002; Demito et al., 2004] as well as
in vivo [gaard et al., 2001; Vivaldi-Rodrigues et al.,
2006]. Collectively, investigations carried out in vitro
and in situ indicate a moderate to strong beneficial efDr. Christina Stecksn-Blicks
Department of Odontology, Paediatric Dentistry, Faculty of Medicine
Ume University, SE901 87 Ume (Sweden)
Tel. +46 90 785 6235, Fax +46 90 770 330
E-Mail christina.stecksen-blicks@odont.umu.se

fect of the tested varnishes on enamel demineralization

while clinical trials are somewhat more inconclusive.
For example, gaard et al. [2001] were not able to demonstrate a dramatic effect of fluoride varnish adjacent to
brackets when compared to treatments with an antibacterial varnish, but both groups exhibited less WSL than
a historical non-treated control group. The study by
Vivaldi-Rodrigues et al. [2006] revealed results slightly
in favour of fluoride varnish in a split-mouth design, but
no placebo varnish was used. It was therefore considered
of interest to further investigate the issue in a doubleblind placebo-controlled trial with two parallel arms.
The aim of the present investigation was to evaluate the
efficacy of repeated topical fluoride varnish applications
on WSL formation in adolescents during the treatment
with fixed orthodontic appliances. The null hypothesis
was that neither the incidence nor the severity of the lesions would differ between the test and the control
group.

Materials and Methods

Subjects
The material consisted of 302 healthy consecutive 12- to 15year-old children (130 boys, 172 girls) that were referred to the
Public Orthodontic Clinics in Skellefte and Lycksele situated in
northern Sweden. Mean age was 14.3 8 1.6 years. To be eligible
for inclusion, the children had to be scheduled for maxillary treatment with fixed orthodontic appliances for an expected duration
of at least 6 months. Sample size was calculated on the basis of the
WSL incidence reported by gaard et al. [2001]. With the - and
-values set at 0.05 and 0.2, respectively, 132 subjects per group
were needed to disclose a 20% difference between the treatment
groups. After verbal and written information, the subjects as well
as one of their custodians gave their consent by signing a protocol.
All the children were informed on the increased risk for demineralization around their brackets and were strongly advocated to
brush their teeth with 1,0001,500 ppm fluoride toothpaste at
least 2 times daily. The fluoride content in the piped drinking water was low (! 0.2 ppm F) in both communities.
Study Design
The study was carried out in a double-blind fashion with a
randomized placebo-controlled design with two parallel arms.
The two-centre project was approved by the local Ethics Committee of Ume University. The patients were assigned to one of the
two groups on the basis of odd and even numbers from a dice. The
subjects were treated by topical applications of either the active or
the placebo varnish immediately after bonding the brackets and
then in connection with every scheduled follow-up during the
period of fixed appliances or approximately every 6th week. The
primary outcome measure was incidence or progression of WSL
as registered with a four-step score as described below.

456

Caries Res 2007;41:455459

Clinical Examination
All included subjects were thoroughly examined before inserting the fixed appliances. After polishing with a rubber cup and
fluoride-free pumice paste and drying with air the presence of
visible white spots or hypomineralizations on all facial surfaces
of the maxillary premolars, cuspids and incisors was recorded.
Three digital photos were exposed (Nikon coolpix with flashlight) and stored on CD discs for future comparison with the clinical status after debonding. Overall baseline caries data according
to WHO criteria [WHO, 1987] were collected from the digital
dental records stored at the Public Dental Clinics. At debonding,
all remaining composite material on the surfaces was thoroughly
removed with a slow rotating carbide bur followed by polishing
with a rubber cup and pumice paste. After drying with air, a new
series of frontal and lateral digital photos was taken and stored on
a disc. For the evaluation of WSL, the photos were projected on a
screen and the incidence and severity of enamel demineralization
were registered separately by 2 experienced and calibrated clinicians according to the index of Gorelick et al. [1982]. The labial
surfaces of the upper incisors, cuspids and premolars were scored
as: 1 = no white spot formation; 2 = slight white spot formation
(thin rim); 3 = excessive white spot formation (thicker bands);
4 = white spot formation with cavitation. The examiners were not
involved in the treatment of the patients and blinded for the group
assignment. Unsharp follow-up photos and slides with poor contrast were categorized as unreadable and counted as dropouts.
The individual scorings were compared and in case of disagreement, the photos were re-examined until a consensus was reached.
A random sample of 50 cases were re-examined after 1 month to
check intra- and inter-examiner reliability.
Orthodontic Appliances
In order to standardize the bonding technique and the volume
of adhesives, pre-coated brackets (Victory Twin APC II 3M Unitek, Monrovia, USA) were used. Each clinician was thoroughly
trained according to the guidelines of the manufacturer prior to
the start of the study and special care was taken not to etch a wider area than needed. The majority of the cases were treated bimaxillary for crowded arches with or without a deep bite, which many
times included extraction of 24 premolars.
Fluoride Varnish Applications
Application of the varnish was performed as the last procedure
at all scheduled orthodontic check-up visits except for emergencies (bracket loss, trauma) or panoramic radiographs. The active
varnish was a commercially available product, Fluor Protector
(Ivoclar Vivadent, Schaan, Liechtenstein), containing 0.1% F as
difluorosilane in a polyurethane varnish base. The placebo varnish applied had an identical composition but without fluoride.
Both varnishes were uncoloured and obtained from the producer
in identical bottles coded by colour. Neither clinicians nor patients knew whether they were treated with fluoride or placebo
varnish. Before application the maxillary teeth were isolated with
cotton rolls and dried with air spray. Visible plaque around the
bracket bases was thereafter removed with an explorer. The varnishes were applied around the bracket bases in a thin layer by
means of a mini-brush and allowed to dry for 2 min. The subjects
were instructed to avoid all eating and drinking for 2 h and not to
brush their teeth until the following day. Approximately 0.20.3
ml of the varnish was used for each application that took approx-

Stecksn-Blicks /Renfors /Oscarson /

Bergstrand /Twetman

Informed consent and

randomization (n = 273)

Fig. 1. Overview of patient flow with inclu-

Fluoride varnish (n = 137)

(Dropouts: relocation = 2,
technical reasons = 2,
aborted treatment = 1)

Placebo varnish (n = 136)

(Dropouts: relocation = 6,
technical reasons = 3,
aborted treatment = 2)

Completed the trial

(n = 132)

Completed the trial

(n = 125)

sions, dropouts and number of patients

completing the trial.

imately 5 min including the setting time. The applications were

repeated on average every 6th week until the removal of the brackets. The duration of the orthodontic treatment time and of each
fluoride varnish application was noted on a separate protocol.
Statistical Methods
All data were processed using SPSS software (version 14.0) and
the colour code was not broken until the calculations had been
performed. The categorized scores were compared by chi-square
tests and the differences between the groups were assessed by the
unpaired Wilcoxon test. The progression score was constructed
by subtracting the debond score from that registered at baseline.
The level of significance was set to 5% (p ! 0.05). The effectiveness of the intervention was calculated and expressed as the absolute risk reduction (ARR, expressed as percent) and number
needed to treat (1/ARR).

Table 1. Prevalence of WSL at baseline and at the time of debonding in the fluoride and placebo-varnish groups

WSL

Fluoride
varnish
(n = 132)

Placebo
varnish
(n = 125)

Prevalence, baseline, %
Prevalence, debonding, %
Incidence, %

4.3
11.7
7.4

4.0
29.7
25.7

>0.05
<0.001
<0.001

Of the 302 consecutive patients that were invited, the

consent form was signed by 273 that entered the study.
During the course of the study, 11 patients dropped out
due to relocation (n = 8) or violation of the treatment protocol (aborted treatment). Since another 5 cases had to be
excluded due to technical failure with the photos, the final material consisted of 257 patients (95%) that completed the trial with full registration (fig. 1). No side-effects or adverse effects were reported by the participants
or by their parents.
The intra-examiner reproducibility of the WSL scores
was kappa 0.77 and the inter-examiner agreement was
kappa 0.69.
The mean baseline caries prevalence expressed as
DMFS was 2.8 8 4.2 in the test group and 2.7 8 3.8 in
the control group (p 1 0.05), and 38% were caries-free

(DMFS = 0). The mean number of varnish applications

was 10.0 8 5.0 in the fluoride varnish group and 10.2 8
3.3 in the placebo varnish group (range 420). The prevalence and distribution of WSL scores at baseline and after debonding is presented in table 1. The prevalence of
WSL was similar in both groups at baseline. The incidence of WSL during the treatment with fixed appliances
in the fluoride varnish group was approximately one
third of that in the placebo group, 7.4 vs. 25.7% (p ! 0.05).
The mean progression score was 0.8 8 2.0 in the test
group compared with 2.6 8 2.8 in the control group and
this difference was statistically significant (p ! 0.001).
The distribution of the WSL scores at the time of debonding is shown in figure 2. Apart from sound surfaces, the
predominant WSL score in both groups was slight thin
rim and very few excessive and cavitated cases were registered. The prevalence of score 2 was significantly lower
in the test group as compared to the placebo control group
(p ! 0.001). The most prevalent teeth with WSL increment were the lateral incisors in both groups followed by
the cuspids in the fluoride varnish group and by the central incisors and premolars in the placebo group (fig. 3).

Fluoride Varnish in Orthodontics

Caries Res 2007;41:455459

Results

457

%
10

%
30
F varnish
Placebo varnish

25

F varnish
Placebo varnish

9
8
7

20

6
5

15

4
3

10

5
0

1
0

Score 2

Score 3

Score 4

Central
incisors

Lateral
incisors

Cuspids

Premolars

Fig. 2. Percentage distribution of WSL score at the time of debonding. Score 2 = Slight white spot formation (thin rim); score 3 =
excessive white spot formation (thicker rim); score 4 = WSL with
cavitation.

Fig. 3. Incidence of WSL in upper incisors, cuspids and premolars

The relative risk reduction, however, was greatest for the

central incisors. The general ARR value was 18% and the
number needed to treat (1/ARR) was 5.5. There was no
significant relationship between caries experience at
baseline and the incidence of WSL during the treatment
with fixed orthodontic appliances.

inter- and intra-examiner agreement indicated an acceptable consistency in the evaluation procedure, although with an anticipated slight underestimation of the
true prevalence.
The results were clear-cut and the null hypothesis
could firmly be rejected. The findings are supportive of
and reinforcing the findings from previous studies in
vivo [gaard et al., 2001; Vivaldi-Rodrigues et al., 2006].
The key element behind fluoride varnishes is the retention and subsequent slow release of fluoride over a prolonged period of time, securing low concentrations available in the liquid plaque-enamel interface. It is commonly accepted that the presence of fluoride may balance the
caries process by diminishing demineralization and promoting remineralization [Petersson, 1993; ten Cate,
2004]. Although the fluoride varnish did not totally prevent WSL formation, the incidence was significantly reduced in the fluoride varnish group. The incidence in the
present control group was around 30%, which was both
higher and lower compared with previous findings from
similar low-caries communities in Sweden [gaard et al.,
2001; Fornell and Twetman, 2004]. Lateral incisors were
affected more often than other teeth. This may be explained by less enamel resistance due to later eruption in
comparison to central incisors. Another reason may have
been that the lateral incisors in many cases had a palatal
position at baseline and thereby were concomitantly subjected to heavier plaque accumulation due to difficulties
in cleaning.

Discussion

This study was undertaken to investigate the regular

use of a fluoride varnish in preventing WSL development
adjacent to fixed appliances. Such lesions are a concern
since, as a worst-case scenario, they might jeopardize the
final aesthetic result of the orthodontic treatment. The
major strengths of the current project were the randomized placebo-controlled double-blind design and the
number of subjects plus the fact that the outcome was
scored by examiners not involved in the clinical procedures. The use of photographs limited the evaluation to
maxillary teeth, but on the other hand, these are the most
frequently affected by WSL [Fornell and Twetman, 2004].
It can, however, be argued that evaluation from a series
of static photographs is by no means comparable with a
live clinical examination, but the examiners were strictly
instructed to score a site as healthy or unchanged rather
than putting a doubtful score. Therefore, it is likely that
the true incidence might be slightly underreported in
both groups of this study. Furthermore, the calculated
458

Caries Res 2007;41:455459

during treatment with fixed appliances in the fluoride and placebo varnish groups.

Stecksn-Blicks /Renfors /Oscarson /

Bergstrand /Twetman

The effectiveness of the intervention was unequivocal

since approximately 5 patients had to be treated in order
to obtain 1 totally free from WSL development. It is also
very likely that the efficiency of the treatment outcome
was favourable from an economic point of view since no
extra recalls with administrative costs were needed. Patients undergoing orthodontic treatment with fixed appliances are often seen for adjustments with 6- to 8-week
intervals. The extra time needed for varnish application
around the brackets was relatively short. It should be
stressed that no side- or adverse effects were reported
during the course of the study and that the topical treatment with the uncoloured varnish had a high acceptance
among the subjects. The dropout patients aborted their
orthodontic treatment for other reasons. The present
finding that the baseline caries experience (DMFS) did
not correlate to the WSL incidence was somewhat unexpected in the light of previous findings. In a study by Fornell and Twetman [2004] it was shown that the presence
of initial proximal lesions on bite-wing radiographs at the
time of insertion of fixed appliances was a relatively
strong predictor for WSL development during the treatment period. In the present study the overall caries prevalence was low and more than one third of participants

were caries-free at baseline. It should also be pinpointed

that the DMFS values mostly reflected accumulated caries experience and mainly included occlusal fillings in
first permanent molars. It is possible that initial proximal
caries may have had a better correlation to caries risk in
this age group.
In conclusion, the results from the present study
strongly suggest that regular topical fluoride varnish applications may reduce the development of WSL adjacent
to the bracket base during treatment with fixed appliances. Thus, fluoride varnish should be advocated as a
professional preventive routine measure in orthodontic
practice.

Acknowledgements
The authors wish to express their gratitude to Mrs. Sonja Oskarsson, Berit Lundstrm, Gerd Lundstrm and Marine Nilsson
at the Public Orthodontic Clinics in Lycksele and Skellefte for
skilful clinical work. The study was supported with grants from
the County Council of Vsterbotten, the Swedish Dental Society,
with varnishes from Ivoclar Vivadent and with brackets from 3M,
Unitek.

References
Adriens ML, Dermaut LR, Verbeeck RM: The
use of Fluor Protector, a fluoride varnish as a
prevention method under orthodontic
bands. Eur J Orthod 1990;12:316319.
American Dental Association Council on Scientific Affairs: Professionally applied topical
fluoride: evidence-based clinical recommendations. J Am Dent Assoc 2006; 137:
http//:jada.ada.org.
Demito CF, Vivaldi-Rodrigues G, Ramos AL,
Bowman SJ: The efficacy of a fluoride varnish in reducing enamel demineralisation
adjacent to orthodontic brackets: an in vitro
study. Orthod Craniofac Res 2004; 7: 205
210.
Fornell AC, Twetman S: Prediction of enamel
demineralisation (white spots) during orthodontic treatment with fixed appliances.
Orthodontics 2004;1:121125.
Gorelick L, Geiger AM, Gwinnett AJ: Incidence
of white spot formation after bonding and
banding. Am J Orthod 1982;81:9398.

Fluoride Varnish in Orthodontics

Helfenstein U, Steiner M: Fluoride varnishes

(Duraphat): a meta analysis. Community
Dent Oral Epidemiol 1994; 22:15.
Mitchell L: Decalcification during orthodontic
treatment with fixed appliances an overview. Br J Orthod 1992;19:199205.
gaard B, Larsson E, Henriksson T, Birkhed D,
Bishara SE: Effects of a combined application
of antimicrobial and fluoride varnishes in
orthodontic patients. Am J Orthod Dentofacial Orthop 2001;120:2835.
Petersson LG: Fluoride mouthrinses and fluoride varnishes. Caries Res 1993; 27(suppl 1):
3542.
Petersson LG, Twetman S, Dahlgren H, Norlund
A, Holm AK, Nordenram G, Lagerlf F,
Sder B, Kllestl C, Mejre I, Axelsson S,
Lingstrm P: Professional fluoride varnish
treatment for caries control: a systematic review of clinical trials. Acta Odontol Scand
2004;62:170176.
Schmit JL, Staley RN, Wefel JS, Kanellis M, Jakobsen JR, Keenan PJ: Effect of fluoride varnish on demineralization adjacent to brackets bonded with RMGI cement. Am J Orthod
Dentofacial Orthop 2002;122:125134.

Sepp L: Efficacy and safety of fluoride varnishes. Compend Contin Educ Dent 1999;20:18
26.
ten Cate JM: Fluorides in caries prevention and
control: empiricism or science. Caries Res
2004;38:254257.
Todd MA, Stanley RN, Kanellis MJ, Donly KJ,
Wefel JS: Effect of a fluoride varnish on demineralisation adjacent to orthodontic
brackets. Am J Orthod Dentofacial Orthop
1999;116:159167.
van der Linden RP, Dermaut LR: White spot formation under orthodontic bands cemented
with glass ionomer with or without Fluor
Protector. Eur J Orthod 1998;20:219224.
Vivaldi-Rodrigues G, Demito CF, Bowman J:
The effectiveness of a fluoride varnish in
preventing the development of white spot lesions. World J Orthod 2006; 7:138144.
WHO: Oral Health Surveys: Basic Methods, ed
3. Geneva, World Health Organisation,
1987.

Caries Res 2007;41:455459

459

Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.