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“Caries Preventive Effect on early carious lesions of Fluoride
Varnish and Fluoride containing Mouth Rinse in 12-14 year old
School Children in Bangalore City”
Dr.S.S.Hiremath MDS
Professor & Head
Dept .of Community Dentistry
Dean cum Director
Govt. DentalCollege
Bangalore
Fort - 2
09448466913
E mail - [email protected]
Dr.Gurmukh Singh MDS
Reader
Dept. of Community Dentistry
Maharaja Ganga Singh Dental College
And Research center
Sri Ganga Nagar
0164-2271038
E mail – [email protected]
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Abstract
Back Ground and Objectives: Fluoride has been the corner stone and integral
part of the preventive programs worldwide. The present study was undertaken
with the objective to assess caries preventive effect, feasibility and cost of fluoride
varnish and fluoride mouth rinse programs for preventing dental caries.
Methods: 228 children in age group of 12 to 14 year were selected and are
randomized in to three groups. Group 1 (77 children)-receiving fluoride varnish
and placebo mouth rinse, Group 2 (75 children) - receiving fluoride mouth rinse
and placebo varnish and Group 3 (76 children) - Control group. A double blind
design was adopted. Caries diagnostic criteria given by Nyvad and Colleagues
(1999) was adopted and caries was diagnosed clinically at both cavitated and
non-cavitated lesion at 6 months, 12months and 18 months.
Results: Fluoride varnish has an efficacy value of 33.26% where as efficacy of
mouth rinse is 31.51% along with an increment of 13.7%DMFS in control group at
the end of 18 months. A total of 66.86% (113/169) initial lesions in the varnish
group and 66.25% (108/163) of the lesions in mouth rinse group healed at
eighteen months compared to baseline. A total of 1.46 and 1.44 surfaces are saved
per child in terms of noncavitated lesions at 18 months. There is substantial
saving of costs in varnish group i.e four times than the conventional restorative
treatment.
Interpretation and Conclusion: Fluoride varnish and fluoride varnish are
effective practical, feasible and cost saving procedures at primary health care
level in school settings.
Key Words: Fluoride varnish; fluoride mouth rinse; DMFS; Cost.
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Professor,Dean & Director ,Govt. Dental College Bangalore,Reader ,Maharaja
Ganga Singh Dental College and Research Center
INTRODUCTION
Despite great achievements in the oral health of populations globally, problems
still remain in many communities around the world - particularly among
underprivileged groups in developed and developing countries1.In India dental caries
afflicts more than fifty percent of the subjects in all age groups varying from 51.9%
to85.0% 2.
Targeting preventive strategies for preventing dental caries at school going
children will go in a long way to decrease the future burden of the disease and to
improve oral and general health related quality of life of the individual and
populations. Children who suffer from poor oral health are twelve times more likely
to have restricted activity days than who don’t have3.Schools provide an effective
platform for promoting oral health because they reach over 1 billion children
worldwide4.
One of the most powerful tool that has been proved beyond doubt, time and
again to control and prevent dental caries in last 50 years is Fluoride.Fortnightly
fluoride mouth rinsing and fluoride varnish application is widely accepted caries
preventive program especially among school children in Scandinavian countries.
The efficacy of Fluoride varnish that varies from 25-80% whereas that of Fluoride
mouth rinses was 30%.Fluoride mouth rinses have been used and shown to be
effective both on a community and on an individual basis.
A considerable body of evidence is already generated concluding these
different modalities as cost effective strategies, to control dental caries. Indeed in
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many low income countries in developing world, the total costs of providing
traditional operative dental care would exceed the entire health care budget.5
Giving due consideration to cost effectiveness of these strategies which varies from
setting to setting in which a program is implemented and also with who provides it,
who receives it and how often, Hence an effort has been made to asses the caries
preventive effect of fluoride varnish and fluoride mouth rinse along with a cost
analysis of these modalities in this field trial.
Objectives of the study
a. To assess caries preventive effect of fluoride varnish and fluoride mouth rinse
for dental caries.
b. To asses the feasibility and to do economic analysis of the two procedures.
c.
MATERIALS AND METHODS
A total of 603 schools in Bangalore city were divided into two main zones
namely, Bangalore north and Bangalore south. Out of these , 3 schools from
Bangalore north (including west part) and 3 schools from Bangalore south
(including east part) were selected by simple random sampling method using
random number table, to achieve the sample size of 228.
Participants were allocated to three groups in this double blind randomized
controlled clinical trial

Group receiving fluoride varnish(active) and mouth rinse(placebo)

Group receiving fluoride mouth rinse (active) and fluoride varnish
(placebo)

Control group (parallel concurrent control)
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Study was conducted in the school premises.
Follow up was performed for 18 months after baseline examination, at six,
twelve and at eighteen months, for recording the caries status by clinical
examination.
DATA COLLECTION
Data are collected through a questionnaire consisted of general information
regarding dietary and oral hygiene practices
of school children
were
recorded in a form designed in English and Kannada through an interview by
the house surgeons which are calibrated at the beginning of the study
Data collection with respect to caries experience was done by a single
examiner throughout the study period. Examiner was calibrated at the baseline
with another examiner (Head of the Department) with a κ value of 80%.
INCLUSION CRITERIA

Subjects having minimum of one initial enamel lesion (non cavitated)
were included in the study.
Caries diagnostic criteria used.
CODE
S
CRITERIA
Sound, normal enamel translucency and texture
Active enamel caries, surface of the enamel is chalky white/yellow
A
opaque appearance with the loss of luster, feels soft or rough on probing.
Presence of small porosity involving enamel only.
Inactive enamel caries surface of the enamel is whitish, brownish or
I
black. Enamel may be shiny and feels hard and smooth on probing.
Small porosity involving enamel only.
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Enamel/Dental cavity easily visible with naked eye: surface of the cavity
D
feels soft and leathery on probing.
P
Dental cavity with pulpal involvement
Nyvad and colleagues 1999.
After drying with a chip blower a visual examination was performed and
when in doubt ,tip of the explorer was used to gently check for the loss of
surface smoothness or the loss of tooth structure.
Non cavitated dental caries lesions were taken in to account. Radiographs
were not used. All teeth whose occlusal surface is visible are considered for
evaluation.
Especially designed Mirrorlite Refills mouth mirror (self illuminating ,anti fog
mirror with a blue white light as recommended by WHO) and explorer
number - 5 Sonden probe REF B 0093 (Dentsply MALLIFER) for
examination were used. Instruments were autoclaved in the department before
every visit to the school
TREATMENT PROCEDURE
Products used:
 Sodium fluoride varnish - Fluoritop SR
A topical application of 0.3 – 0.5 ml of sodium fluoride varnish (5% NaF (2.26%
of F) per subject was applied every six months.
A supervised administration oral mouth rinse of sodium fluoride (0.2%) was
given every fortnightly for one minute.
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Technique of Varnish application.
At baseline oral prophylaxis was done for all the 227 subjects.

Application of fluoride varnish
Step 1 - Each subject was instructed to brush their teeth with the
toothbrush (provided on the spot by the examiner) and plain water.
Step2 - Teeth cleaned with the help of cotton and tweezers
Step3 - Teeth dried with the help of chip blower.
Step4 - Varnish applied to the teeth with help of small custom made
cotton beads.
Step 5 –Varnish was allowed to dry for one minute as per instruction of
the examiner.
Subjects were instructed not to rinse their mouth for one hour and not to
eat for four hours.
COST ANALYSIS
1.Costs included in the evaluation (All costs are in Rupees)
 Direct costs
 Fixed direct cost
Cost of the equipment and material (in Rupees)

Variable direct cost
Cost of the equipment (in Rupees)

Fixed indirect cost
Provider salaries - Calculated in terms of per hour time cost of the
providers through out the trial.
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Receiver salaries
Calculated in terms of half day salary loss of the parent on account of the time
spent to get their child avail the curative treatment(amalgam restoration) and
imputed from annual salary of the students taken from the school records and
also cross checked by asking the students as the records.
Key assumptions used
1. Carious lesions: All will be restored.
2. Initial lesion will proceed to frank lesion over a period of time if not treated.
3. Restoration material used: Amalgam
4. Cost: Class I amalgam restoration = 70/- (Average of rates of nearby Dental
colleges and dental clinics to the study population)
The data was analyzed using SPSS 10.0 package
P value less than 0.05 was taken to be statistically significant.
Results
A total of 219 (95%) (219/228) subjects were available for reexamination at the end
18months consisting of 104 males and 115 females (Table 1). Total dropout rate in
all three study groups at the end of eighteen months = 4%.
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Total number of children randomized after
matching for age and sex in the study = 228
Total number of
children in the
Varnish group = 77
Total number of
children in the Mouth
rinse group =75
Total number of
children in the
Control group = 76
Dropout =1
Total number of
children at 6 months
in Varnish group = 77
Dropout =1
Total number of
children at 12 months
in Varnish group = 76
Dropout =1
Total number of
children at 18 months
in Varnish group = 75
Total number of children
at 6 months in Mouth
rinse group =74
Total number of
children at 6 months in
Control group = 76
Dropouts =2
Total number of children
at 12 months in the
Mouth rinse group =73
Dropouts =2
Total number of children
at 18 months in the
Mouth rinse group =71
Total number of
children at 12 months in
Control group = 76
Dropouts =3
Total number of
children at 18 months in
the Control group = 73
Total number of children
who completed the study
= 219
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The mean age of children in the study group was 13.26 years.
No statistically significant difference exists between males and females in all three
respective groups at baseline with Pearson Chi-Square value of 1.81, 0.753 and 0.867.
At Baseline
Mean DMFS, at baseline for varnish group it is 4.57±3.73 (95% CI = 3.72 to 5.42).
for mouth rinse group 4.76 ±3.62 (95% CI = 3.92 to 5.59). Whereas for control group
it is 4.25 ±3.65 (95% CI = 3.41 to 5.08). No statistically significant differences has
been found among three groups at baseline with p = 0.49.
Coming to mean DS (decayed surface) for initial lesions at baseline, for varnish group
it is 2.22 ±1.72, for mouth rinse group 2.22 ± 1.64, whereas for control group it is
1.93±1.38. No statistically significant differences have been found among three
groups at baseline with p = 0.42 (Table 2)
At six months
Mean DMFS at six months for varnish group, it is 3.83±3.47 (95% CI = 3.04 to 4.61),
for mouth rinse group 4.76±3.62 (95% CI = 3.46 to 5.07) whereas for control group it
is 4.25±3.65 (95% CI = 3.39 to 5.07). No statistically significant differences have
been found among three groups at six months with p = 0.45. However there is a
statistically significant difference in mean DMFS at 6months when compared to
baseline at p = 0.001 in varnish group and in mouth rinse group. A clinical mean
reduction of 0.74±1.84 and 0.49±0.77 DMFS at six months is observed
in Varnish
and Mouth rinse group when compared to baseline. (Figure 1)
Coming to mean DS for initial lesions at six months for varnish group it is 2.22 ±
1.72,for mouth rinse group 2.22 ± 1.64 whereas for control group it is 1.93 ± 1.38.
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No statistically significant differences have been found among three groups at six
months with p = 0.14.
However there is a statistically significant difference in mean DS at 6 months when
compared to baseline in both treatment groups with clinical mean reduction of 0.58
and 0.32 DS in Varnish and Mouth rinse group respectively. (Figure 2& 3)
A total of 28.40% (48 out of 169) initial lesions in the varnish group healed at six
months compared to baseline, out of which pit and fissure lesions contributes
29.16 % (14 out of 48) and smooth surface contributes 70.83 % (34 out of 48) of the
lesions.
A total of 20.24% (33/163) of the lesions in mouth rinse group healed at six months
compared to baseline, out of which pit and fissure lesions contributes 15.15 % (5/33)
and smooth surface contributes 84.84 % (28/33) of the lesions. Whereas there is no
increment in the number of lesions at six months in the control group.
At 12 months
Mean DMFS at twelve months for varnish group, it is 3.67±3.56 (95% CI =
2.86 to 4.48), for mouth rinse group 3.74±3.42 (95% CI = 3.69 to 5.46) whereas for
control group it is 4.57±3.87 (95% CI = 3.69 to 5.46). No statistically significant
differences have been found among three groups at twelve months with p = 0.13.
However there is a statistically significant difference in mean DMFS at twelve months
when compared to baseline at p = 0.001 in varnish group and in mouth rinse group
and p = 0.007 in control group. A clinical mean reduction of 0.89±1.18 and 1.01
±1.45 DMFS at twelve months is observed in Varnish and Mouth rinse group when
compared to baseline, whereas an increment of 0.32±2.35 mean DMFS has been
observed in control group. (Figure 2&3 )
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Mean DS for initial lesions at twelve months for varnish group it is 1.25±1.39,
for mouth rinse group 1.29±1.10whereas for control group it is 2.32±1.76.
Statistically significant differences has been found among three groups at twelve
months with p = 0.001. Also there is statistically significant difference (pair wise)
between varnish-control and mouth rinse-control groups at p = 0.001 at twelve
months.
However there is a statistically significant difference in mean DS at twelve months
when compared to baseline at p = 0.001 in varnish group and mouth rinse and control
group. A clinical mean reduction of 0.97 and 0.80 DS at twelve months is observed in
Varnish and Mouth rinse group when compared to baseline, whereas an
increment of 0.38mean DS has been observed in control group. (Figure 2&3 )
A total of 43.78% (74/169) initial lesions in the varnish group healed at twelve
months compared to baseline, out of which pit and fissure lesions contributes 18.91 %
(14/74) and smooth surface contributes 81.08 % (60/74) of the lesions.
A total of 41.31% (69/163) of the lesions in mouth rinse group healed at twelve
months compared to baseline, out of which pit and fissure lesions contributes 24.63 %
(17/69) and smooth surface contributes 75.36 % (52/69) of the lesions. Whereas there
is an increment 17.68% (26/149) lesions in control group, constituting all the smooth
surface lesions only. (Table 4,6,7 and 8)
Coming to the number of tooth surfaces saved per child at 12 months in terms of
noncavitated lesions, in varnish group it is 0.96 (74/77) surfaces whereas in mouth
rinse group 0.92 (69/75) surfaces are saved.
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At 18 months
Mean DMFS at eighteen months for varnish group, it is 3.05±3.34 (95% CI =
2.49 to 4.04), for mouth rinse group 3.26±3.37 (95% CI = 4.00 to 5.86), whereas for
control group it is 4.93±4.06 (95% CI = 4.00 to 5.86). Statistically significant
differences have been found among three groups at twelve months with p = 0.001.
This difference exists between varnish-control and mouth rinse–control groups (pair
wise).
However there is a statistically significant difference in DMFS at eighteen months
when compared to baseline at p = 0.001 in varnish, mouth rinse group and control
group A clinical mean reduction of 1.51±1.46 and 1.49±1.42 DMFS at eighteen
months is observed in varnish and mouth rinse group when compared to baseline,
whereas an increment of 0.68±1.2 mean DMFS has been observed in control group.
(Figure 2 &3)
Mean DS for initial lesions at eighteen months for varnish group it is 0.71±1.14, for
mouth rinse group 0.77±0.95 whereas for control group it is 2.47±1.8. Statistically
significant differences has been found among three groups at eighteen months with
p = 0.001.
However there is a statistically significant difference in mean DS at eighteen months
when compared to baseline at p = 0.001 in varnish group and in mouth rinse
and p = 0.001 in control group group. A clinical mean reduction of 1.51 and 1.32 DS
at eighteen months is observed in Varnish and Mouth rinse group when compared to
baseline, whereas an increment of 0.54 mean DS has been observed in control
group. A total of 66.86% (113/169) initial lesions in the varnish group healed at
eighteen months compared to baseline, out of which pit and fissure lesions contributes
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23.89 % (86/113)and smooth surface contributes 76.10 % (27/169) of the lesions.
(Figure 2&3 )
Coming to the number of tooth surfaces saved per child at 18 months in terms of
noncavitated lesions in varnish group it is 1.46 (113/77) surfaces whereas in mouth
rinse group 1.44(108/75) surfaces are saved.
There is a clinical mean increment of 0.15 decayed surfaces in terms of cavitated
lesion at eighteen months in control group which is statistically significant at p=0.008.
The fluoride varnish has an efficacy value of 33.26% where as efficacy of fluoride
mouth rinse is 31.51%. (Figure 1)
Acceptability of the Varnish application
On the whole varnish is acceptable to majority of the children as 96.1% of the
children are willing to go for the procedure again and only 7.79 % of the children
reported some kind of pain or discomfort during the procedure where as only 3.90%
of the children reported some kind of pain or discomfort after the procedure.
Time taken for the Varnish application
Mean time taken for varnish application 6 minutes ± 0.74 seconds.
Amount of fluoride varnish used per child per application
0.5ml per child per application
Cost analysis
1. Costs included in the evaluation (All costs are calculated in Rupees)
• Direct costs
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Variable direct cost
Fixed indirect cost
Provider salaries
Calculated in terms of per hour time cost of the providers through out the trial.
15
Total cost of equipment used through out the trial = 3945/Total cost of mouth rinse administration through out the trial = 278 X 23 = 6394/Total cost of time spent on mouth rinse administration = 36.6 X 18 hrs = 658.8/-
Total cost of mouth rinse administration per child for 18 months = 6394+658.8 / 75
=101.24/Total cost of one mouth rinse administration per child= 101.24/32= 3.16/Total cost of varnish application through out the trial = 4 X 350 = 1400/Total cost of time spent on varnish application = 36.6 X 19hrs = 695.4 /Total cost of varnish application per child for 18 months= 1400+695.4 / 77=27.2/Total cost of one varnish application per child= 27.2/3= 9/-
2. Cost averted
Receiver salaries
Calculated in terms of half day salary loss of the parent on account of the time spent
to get their child avail the curative treatment (amalgam restoration) and imputed from
annual salary of the students taken from the school records and also cross checked by
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asking the students as the records.
Average salary of the parent in Varnish group is (per month) = 2914/Total number of surfaces saved in Varnish group = 113 surfaces
Cost averted in Varnish group = (Number of surfaces saved x Average half day
salary of the parent) + (Number of surfaces saved x Cost of class I amalgam
restoration) Cost averted in Varnish group = (113 x 48.5) + (70 x 113) = 13390/-
Cost per tooth surface saved in varnish group = 13390 / 113 = 118.4/Average salary of the parent in Mouth rinse group is (per month) – 2910/Total number of surfaces saved in the Mouth rinse group = 108 surfaces
Cost averted in Mouth rinse group = (Number of surfaces saved x Average half day
salary of the parent) + (Number of surfaces saved x Cost of class I amalgam
restoration)
Cost averted in Mouth rinse group = (108 x 48.5) + (70 x 108) = 12798/Cost per tooth surface saved in mouth rinse group = 12798 / 108 = 118.5/-
Fluoride varnish has more savings in terms of cost than fluoride mouth rinsing
(Rs 74/-) when cost of administering the therapy was considered for
18 months.
Average salary of the parent in Control group is (per month) = 2810/Increase in number of carious surfaces in the Control rinse group = 50 surfaces
17
Cost incurred in Control group = (Increase in number of carious surfaces x Average
half day salary of the parent) + (Increase in number of carious surfaces x Cost of
class I amalgam restoration)
Cost incurred in Control group = (50 x 46.8) + (70 x 50) = 5840/-
Discussions
When comparing the findings or results of the present study with other
clinical investigations, it is paramount to recognize that many variables like
the age of the subjects, selection of subjects, oral hygiene habits, past caries
experience, past fluoride exposure of the subject duration of the study and so
on will exist, which will have an impact on the outcome of the procedure that
are being studied.
Actual caries preventive effect of fluoride varnish and fluoride mouth rinse on frank
cavitated lesions is difficult to measure in present study. Moreover no diagnostic
criteria to measure caries progression in cavitated lesions has been used. However We
are interested to find out is there any chance of noticing further progression of the
caries lesion and if any development of new lesion. Hence we did include frank
lesions in this study to see caries preventive effect of both fluoride mouth rinse and
fluoride varnish along with the measurement of caries preventive effect of both
fluoride varnish and fluoride mouth rinse on initial lesions.
The present study has a balanced representation of DMFS score in all groups with a
relatively lower caries prevalence compared to other studies Seppa and Pollanen7,
Koch etal.8
Though the present study has taken in to account both cavitated and noncavitated
dental caries lesion, no statistically significant differences has been found among
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three groups at six months. However there is a statistically significant clinical mean
reduction of 0.74 and 0.49 DMFS in respective groups when compared to baseline.
The decrease here also is primarily on account of healing of active noncavitated
lesions present at the baseline.
However mean DS for non cavitated lesions at six months statistically significant
difference (pair wise) existed between varnish-control and mouth rinse - control
groups with a clinical mean reduction of 0.58 and 0.32 DS at six months in respective
groups.The significant reduction here may be, is primarily on account of strict
compliance to the therapy as both procedures are supervised.
A total of 28.40% of non cavitated lesions in the varnish group and 20.24% in mouth
rinse group healed at six months compared to baseline. As expected smooth surface
account for majority of the healed lesions.Whereas there is no increment in the
number of lesions at six months in the control group as the population in general has
a slow caries progression.
The intergroup and intra group dental caries score difference
following
at 12months is
the same trend as at 6 months ,along with a statistically significant
difference in DS score between three groups and also the clinical mean reduction
compared to baseline almost doubled at 0.97 and 0.80DS(non cavitated) in respective
groups indicating clinical evidence of continuing increase in preventive effect of both
therapies. There was also an increment of 0.32 mean DMFS and 0.38 mean DS(non
cavitated) in control group partly because more number of teeth erupted
(2nd
molars,2ndpremolars) in all age groups.
Total of 0.96 and 0.94 per year surfaces were saved in varnish and mouth rinse
group in terms of non cavitated lesions.
19
A statistically significant difference in all DMFT ,DMFS(both cavitated and non
cavitated)
,DT and DS (non cavitated ) score between three groups became evident
only at 18 months partly because of continuous effect of the two therapies and also
on account of increase in number of cavitated lesions with clinical mean increment of
0.15 decayed surfaces is noted at 18months in control group.
The finding that the two fluoride treatments are equally effective for the inhibition of
dental caries is concordant with the general impression from numerous short term
clinical trials testing various topical fluoride treatments that caries reductions
obtained from non specific application of fluoride in preventive programs is very
similar irrespective of the mode of fluoride administration.It is most likely, therefore
that any difference in the cariostatic capacity between the two treatments would have
been modest and thereby difficult to detect in a population as in the present study
with a pre existing low caries activity.
No statistically significant differences have been found between fluoride varnish and
fluoride mouth rinse group in the present study at 18 months. The results are in line
with three-year study done by Brunn et al9 in Netherlands in a population and with
a five-year study done Kirkegaard et al10 on permanent teeth in 9-year-old children
in Denmark with a relatively similar caries experience at the baseline.
Combined efficacy of the two preventive therapies in both groups is about 32.4%.
which is slightly lesser than the study by Seppa and Pollanen (39%)7 and by Koch et
al (43%)8.
20
The efficacy 33.26 % of the fluoride varnish in the present study is in range of the
range of the review done by Petersson et al (0% to 69%)11, Marinho et al (29% to
64%).12
The efficacy 31.51 % of the fluoride mouth rinse in the present study is in range of the
range of the review done by Twetman et al13 (14% to 53%) and slightly higher than
in the review done by Marinho et al 14(23% to 30%).
A statistically significant, clinical mean increment of 0.15 decayed surfaces in the
present study in terms of cavitated lesion at eighteen months occured in control
group.Majority of studies have evaluated the effect of two therapies with respect to
increment in cavitated lesioins .However due to time constraint and relatively slow
caries progression along with comparitivly low initial caries prevalence the present
study was not able to evaluate the effect of two therapies with respect to increment in
cavitated lesions.
Findings of the present study have significant implications for instituting
the two
preventive therapies in school health programmes, as the it has shown the significant
caries reduction even in groups with relatively low caries experience at baseline in
addition to the variable but non significant exposure to fluoride tooth paste in the
study population.
Dropouts at the end of eighteen months amounts to 4% of the study population.There
were no Dropouts on account of the two treatment therapies.
Fluoride varnish (both placebo and active form) was accepted well by the children.
The time taken for varnish application per child in the present study is 6 ± 0.74
minutes. However the utilization of the fluoride solution depend on the quality of
21
the fluoride varnish that is its viscosity, flow and rapidity with which it dries after
application on the teeth etc.
Feasibility
Both the intervention therapies are is ideal in a primary health care setting in a school
as they do not require any expensive equipment in terms of hand piece, suction
apparatus etc and above all the procedures can be accomplished without the direct
involvement of dentist that is in case of fluoride mouth rinsing school teachers can be
made use of and in case of fluoride varnish with a minimum basic guidance dental
assistant or school dental nurse can accomplish the procedure. With virtual nonexistence of dental manpower at primary health care level this is a promising option,
which needs further exploration in a setting like ours. Only thing which may be a
temporary hindrance in its implementation is the availability of the fluoride varnish in
India, but with more field trials proving its
efficacy, this seems to be a temporary trend in coming future and also fluoride
varnishes are easy to handle and are toxicologically more safe as the risk of ingestion
is less. And again fluoride mouth rinse can easily be prepared in the school premises
itself with little bit of extra caution and training of the existing health personnel.
Cost analysis
In the present study cost analysis of the two treatment modalities were performed
along side trial.
Total cost of equipment used through out the trial = 3945/(including fixed costs and variable direct costs in the study)
Total cost of mouth rinse administration per child = 6394+658.8 / 75 =101.24/22
(Includes the cost of the fluoride mouth rinse and cost of the personnel are calculated
in terms time spent for the program from the average per day salary of the personnel
involved in the study)
Cost averted in Mouth rinse group = (108 x 48.5) + (70 x 108) = 12798/Cost per tooth surface saved in mouth rinse group = 12798 / 108 = 118.5/-
However the cost can be significantly brought down with the involvement of the
teachers in mouth rinsing program with little extra cost and also by making the rinse
in the school premises in itself will be a viable and practical option to decrease cost.
Total cost of varnish application per child = 1400 + 695.4 / 77=27.2/(Includes the cost of the fluoride varnish and cost of the personnel are calculated in
terms time spent for the program from the average per day salary of the personnel
involved in the study)
Cost averted in Varnish group = (113 x 48.5) + (70 x 113) = 13390/Cost per tooth surface saved in varnish group = 13390 / 113 = 118.4/-
This is a very promising result as there is more than four times saving in terms of cost
incurred compared to conventional restorative treatment. Still the benefits on part of
the patient will be larger considering the decrease in quality of life in future on
account of carious tooth. A surprisingly low cost of the varnish in India 117/- for 10
ml bottle compared to western countries where it is on an average 2200/- for 10ml
bottle is one key reasons for such huge savings in cost. However to be vary pragmatic
not all the non cavitated lesions will progress to frank cavitations but still the
magnitude of savings will be substantial in latter case.
23
Cost incurred in Control group = (50 x 46.8) + (70 x 50) = 5840/No direct comparison can be made for each of these findings as the cost analysis
varies from the setting-to-setting depending on who provides it, who receives it and
how.
The presence of savings in cost in both the modalities are in agreement with studies
done by Skold et al 15, Petersson and Westberg16 and Doherty et al.17.
Conclusion
No statistically
significant difference was found among fluoride varnish and
mouthrinse group at the end of 18 months.The combined efficacy of the two fluoride
modalities is 32.4%.Both
level.Though
therapies are
highly cost effective at community
fluoride varnish is more economically viable,mouth rinsing stands
practically more feasible in a community setting.
Bibliography
1. Poul Erik Petersen, The World Oral Health Report 2003 Continuous
improvement of oral health in the 21st century - the approach of the WHO Global
Oral Health Programme,Oral Health Programme, Noncommunicable Disease
Prevention and Health Promotion, World Health Organization, Geneva,
Switzerland.
2. National Oral Health Survey and Fluoride Mapping 2002 – 2003. Dental
council of India, New Delhi, 2004.
24
3. US General Accounting Office’s .Oral Health dental disease is a chronic
problem
among
low-income
populations.
Washington,
DC:
Report
to
Congressional Requesters; 2000.
4. The Status of School Health Report of the School Health Working Group and
WHO Expert Committee on Comprehensive School Health Education and
Promotion.Geneva:World Health Organisation;1996.
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Cost and Cost-Effective Analyses to preventive Dental Programs. J Public Health
Dent 1984 ; 44 :156-68.
7.Seppa L, Pollanen L . Caries preventive effect of two fluoride varnishes and a
fluoride mouthrinse. Caries Res. 1987;21(4):375-9.
8. Koch G, Petersson LG, Ryden H .Effect of flouride varnish (Duraphat)
treatment every six months compared with weekly mouthrinses with 0.2 per cent
NaF solution on dental caries. Swed Dent J. 1979;3(2):39-44.
9.Bruun C, Bille J, Hansen KT, Kann J, Qvist V, Thylstrup A . Three-year caries
increments after fluoride rinses or topical applications with a fluoride
varnish.Community Dent Oral Epidemiol. 1985 Dec;13(6):299-303.
10.Kirkegaard E, Petersen G, Poulsen S, Holm SA, Heidmann J .Cariespreventive effect of Duraphat varnish applications versus fluoride mouthrinses:
5-year data. Caries Res. 1986;20(6):548-55.
11. Petersson LG et al .Professional fluoride varnish treatment for caries control:
a systematic review of clinical trials. Acta Odontol Scand. 2004 Jun;62(3):170-6.
12. Marinho VC, Higgins JP, Sheiham A, Logan S. One topical fluoride
(toothpastes, or mouthrinses, or gels, or varnishes) versus another for preventing
25
dental caries in children and adolescents. Cochrane Database Syst Rev.
2004;(1):CD002780
13. Marinho VCC, Higgins JPT, Logan S, Sheiham A. Fluoride mouth rinses for
preventing dental caries in children and adolescents. The Cochrane Database of
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14. Svante Twetman et al . Caries-preventive effect of sodium fluoride
mouthrinses: a systematic review of controlled clinical trials Acta Odontologica
Scandinavica Volume 62, Number 4 / August 2004.
15. Skold L, Sundquist B, Eriksson B, Edeland C .Four-year study of caries
inhibition of intensive Duraphat application in 11-15-year-old children.
Community Dent Oral Epidemiol. 1994 Feb;22(1):8-12.
16. Petersson LG, Westerberg I.Intensive fluoride varnish program in Swedish
adolescents: economic assessment of a 7-year follow-up study on proximal caries
incidence.Caries Res. 1994;28(1):59-63.
17. Doherty NJ, Brunelle JA, Miller AJ, Li SH. Costs of school-based
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Epidemiol. 1984 Feb;12(1):35-8.
26
Figures and Tables
Distribution of the children according to age and gender in the study population
Table 1
Group
Varnish group
Mouth rinse
Control group
N
77
75
76
Males
37(48.1%)
34(45.3%)
38(50%)
Females
40(51.9%)
41(54.7%)
38(50%)
Mean age
13.25
13.30
13.23
Distribution of the children according to mean DMFT and DMFS scores in the
study groups
Table 2
Results of kruskal wallis test comparing mean DMFT and
DMFS between three groups at 18 months
Table 3
27
Results of kruskal wallis test comparing mean DT and DS
between three groups at 18months
Table 4
28
29
30