Fluoride varnish

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. 1.Parental counseling plus fluoride varnish
twice/year with four intended applications
(baseline, 6, 12, and 18 M - 4FV);
2.Parental counseling plus fluoride varnish
once/year with two intended applications
(baseline and 12 M - 2FV);
3.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 children’s 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 Dentistry’s (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 children’s teeth with a fluoride
paste to minimize total fluoride exposure that day.
*The control group’s 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, χ2 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. 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.
Data Analysis

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 child’s 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.
Limitations

29. *Double blind procedure - Yes
*Randomized –Yes
*Randomization - computer-generated
Closed envelope
*Complete follow up – No
Is My Study Valid?

30. *Patients analyzed in original groups - YES
*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.
It’s 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.

35. *Dr. Aneesh Tosh
*Dr. John Hewett
Special Thanks to

36. Questions?