1. Fluoride Varnish EBM Conference Smruthi Sanath M.D.
Department of Pediatrics University of Missouri, Columbia
2.
A 2 y/o caucasian boy seen in clinic for wcc. His family
recently moved from a different state. The boy was seen by a
dentist (?for caries) and had a single fluoride application
(when).
ROS-Negative.
PE- 3 caries noted.
Clinical question: What is the efficacy of Fluoride varnish in
preventing dental caries?
Clinical Case
3.
Key words: Fluoride varnish in children- 281
Limits: English, United states of America- 56
Advanced search: prevention of dental caries- 8
Fluoride Varnish Efficacy in Preventing Early Childhood
Caries
J.A. Weintraub , F. Ramos-Gomez , B. Jue , S. Shain , C.I.
Hoover , J.D.B. Featherstone , and S.A. Gansky
Search
4.
Various fluoride varnish application frequencies with
parental/caregiver oral health counseling vs. counseling alone
in
Preventing early childhood caries incidence in
Initially caries-free young children.
Objective
5.
P- Low-income Chinese or Hispanic families in San
Francisco
I- Fluoride varnish + Counseling
C- No varnish + Counseling
O- Incidence of dental caries
6.
children age 6-44 months
four erupted primary maxillary incisors
caries-free teeth without demineralized, white spots
born in San Francisco or a fluoridated community in the Bay
Area
a parent providing informed consent
October, 2000 - August, 2002
Well Child Clinics, WIC, and dental clinics
53 % were girls and 47% were boys
Inclusion criteria
7.
Children with medical problems or medications possibly
affecting oral health;
cleft lip/palate;
developmental disabilities;
transient residence;
another household member participating.
Exclusion criteria
8.
Parental counseling plus fluoride varnish twice/year with four
intended applications (baseline, 6, 12, and 18 M - 4FV);
Parental counseling plus fluoride varnish once/year with two
intended applications (baseline and 12 M - 2FV);
Counseling only, with no fluoride varnish(0FV).
Groups
9.
Dental examinations, without radiographs, were conducted three
times:
at baseline, prior to the intervention,
one and
two years post-intervention.
Older childrens examinations were conducted in a dental office;
very young children had a knee to knee examination
Measurements
10.
factors associated with early childhood caries,
potential confounders, and
effect modifiers, including
sociodemographic,
biologic, and
behavioral factors - bottle use, diet, and dental
utilization.
Parents interview
11.
The annual counseling protocol followed the American Academy of
Pediatric Dentistrys (AAPD) anticipatory guidance recommendations
(Nowak and Casamassimo, 1995; Nowak, 1998).
Thus, it was inappropriate for the control group to receive an
examination without counseling or education having been
provided.
Individualized counseling visits followed these age-specific
recommendations (6-12 months, 12-24 months, 2-5 years), in the
parents preferred language, by a trained team member.
Parental Counseling
12. Fluoride Varnish Application
Teeth were dried with gauze, and varnish was brushed onto all
surfaces of the maxillary and mandibular anterior teeth, and the
proximal and occlusal surfaces of the posteriors.
Duraphat Colgate Oral fluoride varnish - 1 drop per arch.
Parents were asked not to brush their childrens teeth with a
fluoride paste to minimize total fluoride exposure that day.
The control groups tray set-up was the same but only dry gauze
without fluoride varnish was applied.
One dentist performed applications on all children.
13. Primary Outcome
any caries incidence
NIDCR diagnostic criteria for dental caries (USDHHS, 1991) for
assessing cavitated, decayed (d2+), and filled surfaces on primary
teeth (d2+fs).
supplemental criteria (Drury et al. , 1999) to diagnosis
precavitated lesions (d1).
One pediatric dentist, masked to treatment group, conducted all
dental examinations.
Intra-examiner reliability, from repeat examinations of 21
children, yielded a kappa statistic of 0.96, indicating excellent
agreement.
Two years of follow-up were planned unless caries was detected
at the one-year follow-up examination, in which case children were
considered treatment failures and were referred for dental
care.
14.
Authors planned a sample size of 384 participants (128/study
arm) (alpha = 0.05, power = 90%, 50% attrition, 2 test) to detect
caries incidence differences, based on caries incidence in the
literature (20% to 50% over two years).
A similar study (Weinstein et al. , 1994) reported 53%
attrition in six months.
SAMPLE SIZE
15. Data Analysis
Intention-to-treat (ITT) analysis
retains patients throughout every step of analysis in the
groups to which they initially were randomly assigned.
used to avoid bias and overestimation of effect in RCTs.
Protocol-compatible analyses used number of actual active
fluoride varnish applications.
Logistic regression to test treatment group differences.
Linear regression to compare groups.
96 children had no followup examination complicated statistical
analysis were performed to adjust for this.
16.
376 children enrolled and randomized - mean age of 1.8 (+/-0.6)
yrs - 200 at SFGH and 176 at CPHC.
47% were Hispanic,
46% were Asian, and
7% were other race/ethnicity.
No randomization imbalances were apparent.
About 60% of those screened and found to be ineligible had
existing dental caries.
RESULTS
17. Groups equal
18. Patients lost to f/u equal
19.
At the 12-month follow-up examination, 70% of enrolled children
(n = 261) were seen; 51 of them were discontinued from the study
due to caries, and were referred for care.
20.
At the final, 24-month follow-up, 202 children were seen (67%
retention).
21.
Due to an unexpected protocol violation, some children
unintentionally received a placebo varnish instead of active
product.
Protocol Deviation
22.
Primary analysis showed a statistically significant reduced
percentage of children with any caries incidence (any decayed or
filled surfaces at the last follow-up examination), when children
in groups with any intended fluoride (2 or 4 treatments) were
compared with the control group
The percentage of children with caries decreased with
increasing numbers of intended or actual active applications
linearly(both p < 0.001)
No adverse events or safety issues resulting from the fluoride
varnish use were reported by accompanying adults.
Clinical Outcomes
23. Caries incidence
24. Caries incidence
25.
Fluoride varnish prevents early childhood caries and reduces
caries increment in very young children (www.aaphd.org, 2004).
Guidelines support a dental assessment by a childs first
birthday or first tooth eruption.
Fluoride varnish efficacy in this age group provides additional
rationale for an early dental visit, especially for
high-caries-risk children, since the application of fluoride
varnish at this first visit will help reduce future disease.
Some children were even younger than age 1 at the first visit.
Authors had little difficulty with cooperation of the young infants
with the fluoride varnish.
DISCUSSION
26.
Public facilities sometimes find it difficult to see children
at regular six-month intervals. Thus, determining the efficacy of
only one application of varnish a year was important. Although more
frequent varnish applications were more beneficial, one application
was preferable to none.
Many children with caries at the screening examination were
ineligible. This study was intended to determine the success of
preventing caries incidence, not increment. It did not address
fluoride varnish efficacy for children with extant caries.
27.
This findings are more generalizable to settings serving many
high-caries-risk children than other potential locations. Similar
results from the two clinical sites with different populations
increase generalizability of the findings.
Fluoride varnish and parental counseling should be recommended
as part of caries prevention programs targeting infants and
toddlers.
28.
Information on use of fluoride containing toothpaste or
mouthwash not reported
Some patients lost to follow-up
Protocol violation
Did not test efficacy of Fluoride varnish in children with
existing caries.
Similarity of groups - YES: there was no significant difference
between the groups.
This study is VALID for the clinical situation and outcome of
interest
Is My Study Valid?
31.
Q: Number of applications that is most efficacious?
A: Two, based on statistics; One is better than none; more
applications appear to perform even better.
Q: Does only fluoride application help?
A: Counseling also can make a difference.
Q: Can I use this clinically?
A: Yes. We see children of this age more often than
dentists.
Discussion
32.
Early childhood caries predisposes to caries throughout life;
so start during prenatal period.
Talk about
Fluoride varnish
Bottle use & Thumb sucking - tooth eruption
Premature babies - Poor tooth structure Fluoride varnish may be
more beneficial to them.
Anticipatory guidance is very important in WCC.
Counseling tips for our clinic
33.
Fluoride alters the structure of the developing enamel making
it more resistant to acid attack.
reduces the ability of the plaque bacteria to produce
acid.
decreases the depth of the fissures on the biting surfaces of
the teeth.
Mechanisms of Fluoride benefits
34. Too much of a good thing!
Columbia Tribune - Friday, January 7, 2011
ATLANTA (AP) Fluoride in drinking water credited with
dramatically cutting cavities and tooth decay might now be too much
of a good thing. Its causing spots on some kids teeth.
The standard since 1962 has been a range of 0.7 to 1.2
milligrams per liter.
The Centers for Disease Control and Prevention reports the
splotchy tooth condition, fluorosis, is unexpectedly common in kids
ages 12 through 15. And it appears to have grown much more common
since the 1980s.
Health officials note most communities have fluoride in their
water supplies, and toothpaste has it, too. Some kids are even
given fluoride supplements.
The U.S. Department of Health and Human Services is proposing
to change the recommended fluoride level to 0.7 milligrams per
liter of water.
And the Environmental Protection Agency will review whether the
maximum cutoff of 4 milligrams per liter is too high.