ADA topical fluoride guideline (2013): 2.26% varnish, 1.23% APF gel, 0.5% home gel and 0.09% rinse, for elevated-risk patients only

What it says#

A panel convened by the ADA Council on Scientific Affairs updated the ADA's 2006 recommendations on professionally applied topical fluoride and extended them to prescription-strength home-use products. The method changed with the update: the 2006 recommendations were built primarily on published systematic reviews and graded on study design, while the 2013 recommendations rest on a de novo systematic review of primary studies and are graded on the net benefit of the intervention combined with the level of certainty in the evidence, using a system adapted from the US Preventive Services Task Force. The search covered MEDLINE and the Cochrane Library for trials with caries increment outcomes published in English through October 2012, and the panel included 71 trials from 82 articles.

Two questions were asked. First, in primary and permanent teeth, does a topical fluoride agent reduce the incidence of new coronal or root caries lesions compared with no topical fluoride? Second, does a prophylaxis before application improve on application without one? The grading runs on two axes. The level of certainty is high, moderate or low; the net benefit rating is benefit outweighs potential harm, benefit balanced with potential harm, or no benefit and potential harm outweighs benefit. The two combine into a strength: strong, in favor, weak, expert opinion for, expert opinion against, or against. No evidence statement in the report reached high certainty, so no recommendation is strong; the panel says the strengths of the recommendations for the recommended products varied from in favor to expert opinion for.

The concentrations are set out in the report's Table 6 as fluoride ion and sodium fluoride: 2.26% fluoride varnish is 5.0% sodium fluoride; APF gel and foam with 0.1 molar phosphoric acid are 1.23% fluoride and 2.7% sodium fluoride; fluoride prophylaxis paste is 1.23% fluoride, most of it as APF; the low-concentration varnish is 0.1% fluoride in difluorsilane form; prescription-strength home gels or pastes are 0.5% fluoride and 1.1% sodium fluoride; prescription-strength mouthrinses are 0.09% fluoride and 0.2% sodium fluoride. The ADA's fluoride topic page gives the same figures in parts per million: 2.26% is 22,600 ppm, 1.23% is 12,300 ppm, and the 0.1% difluorsilane varnish is 1,000 ppm.

The evidence statements go agent by agent and age by age. For 2.26% fluoride varnish applied at least twice per year, the panel found a benefit with moderate certainty in children under 6 and in children 6 through 18, and a benefit with low certainty for adult root caries; in each case the benefit outweighed the potential harm. For 1.23% APF gel applied for four minutes, the panel found a benefit up to every three months with moderate certainty in children 6 through 18, and a benefit twice per year with low certainty for adult root caries, but judged that in children under 6 the potential harm from swallowing outweighed the benefit. Prescription home-use 0.5% fluoride gel or paste twice daily and 0.09% fluoride mouthrinse daily or weekly carried a benefit that outweighed potential harm from age 6 up, including for adult root caries; both were ruled out under 6 on the swallowing risk.

Three agents came back negative. The 0.1% difluorsilane varnish showed no benefit in children under 6 with moderate certainty and none in children 6 through 18 with low certainty. APF foam showed no benefit in the permanent dentition of children, and in children under 6 the panel judged the potential harm of swallowing to outweigh the benefit it did find. Fluoride prophylaxis pastes showed no benefit in either dentition. A prophylaxis before APF gel showed no benefit either, with moderate certainty in children 6 through 18. The panel notes that varnish dispensed in unit doses has lower potential for harm than other high-concentration agents, because the amount of fluoride placed in the mouth is about one-tenth that of other professionally applied products.

Who it applies to#

Patients at elevated risk of developing dental caries, in three bands: under 6 years, 6 through 18 years, and adults, with adult root caries treated as its own population. Most of the adult recommendations are extrapolations, since the panel found no studies of coronal caries prevention in adults older than 18 for varnish, gel or rinse and reached those recommendations at the strength of expert opinion.

Low-risk patients are outside it. The panel recommends topical fluoride agents only for people at elevated risk and says patients at low risk of developing caries may not need additional fluoride interventions, noting that a patient's risk status includes whether they live in an optimally fluoridated community and use fluoridated toothpaste. So is anything the panel did not review: over-the-counter products, slow-release devices, fluoride-releasing dental materials, sodium monofluorophosphate, silver diamine fluoride and titanium tetrafluoride, the last two because the panel says they were not available in any products in the United States at that time. That gap is what the 2018 nonrestorative guideline later filled for SDF, and what the AAPD fluoride therapy best practice covers for supplements and community water.

What changed#

Against the 2006 recommendations, the substance changed in three visible places. Prescription-strength home-use products were brought inside the recommendations for the first time. The grading moved from study design to a certainty-plus-net-benefit grid, which is why several products the profession had used for years came out as no benefit or as expert opinion rather than as endorsements. And the report made the under-6 rule explicit and narrow: unit-dose 2.26% varnish and nothing else.

Read next to the caries guidelines that followed, this one is the prevention half of the pair. It says what to put on a tooth that is still sound or still at risk; the 2018 nonrestorative guideline says what to put on a lesion that already exists, and it is the document that added SDF and 5,000 ppm home fluoride to the ADA's recommendations. The ADA lists a caries prevention guideline as in progress, so expect this 2013 text to be superseded.

Where the source is#

The link under the title opens the free full text of the executive summary at PubMed Central, which was read for this entry, including the certainty and net benefit definitions (Tables 1 to 3), the evidence statements by agent and age group (Table 5) and the concentration table (Table 6). The panel's Table 4, which prints the final strength assigned to each recommendation, is reproduced in that version as an image rather than as text, so this entry reports each recommendation by the certainty and net benefit the panel published for it, plus the panel's own summary that the strengths ran from in favor to expert opinion for. An erratum for a dosage error in the article text ran in JADA 144(12):1335; the corrected prescription home-use figure is 0.5% fluoride gel or paste, which is what the full text and the ADA's topic page both carry. The parts-per-million equivalents come from the ADA's fluoride oral health topic page, also read for this entry.