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

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• 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

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• Children with medical problems or medications possibly affecting oral health;

• cleft lip/palate;

• developmental disabilities;

• transient residence;

• another household member participating.

Exclusion criteria

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• 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

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• 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

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• 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

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• Double blind procedure - Yes

• Randomized Yes

• Randomization - computer-generated Closed envelope

• Complete follow up No

Is My Study Valid?

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• 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

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• 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.

35.

• Dr. Aneesh Tosh

• Dr. John Hewett

Special Thanks to

36. Questions?