Professional fluoride varnish treatment for caries control: a systematic review of clinical trials

The aim of this paper was systematically to evaluate the caries-preventive effect of professional fluoride varnish treatments. A search of the literature for articles published between 1966 and August 2003 was carried out in electronic databases, reference lists of articles, and selected textbooks in accordance with the strategy of the Swedish Council on Technology Assessment in Health Care. Out of 302 identified papers, 24 randomized and controlled clinical trials comparing fluoride varnish with placebo, no active treatment or other fluoride preventive regimens of at least 2 years' study duration were included. The trials that met the inclusion criteria were assessed independently and systematically by at least two reviewers and scored from A to C according to predetermined criteria for methodology and performance. The main outcome measure was the preventive fraction expressed as a percentage. The results displayed limited evidence (evidence level 3) for the caries preventive effect of topical applications of fluoride varnishes in permanent teeth. The average prevented fraction was 30% (0-69%) when compared with untreated controls. Inconclusive evidence (evidence level 4) was found for fluoride varnish treatment in the primary dentition and in adults. This systematic review reinforces the need for future dinical research of high quality, incorporating modern concepts of dinical performance and evaluation to assess dental caries control using professional fluoride varnish.     

Professional fluoride varnish treatment for caries control: a systematic review of clinical trials

The aim of this paper was systematically to evaluate the caries‐preventive effect of professional fluoride varnish treatments. A search of the literature for articles published between 1966 and August 2003 was carried out in electronic databases, reference lists of articles, and selected textbooks in accordance with the strategy of the Swedish Council on Technology Assessment in Health Care. Out of 302 identified papers, 24 randomized and controlled clinical trials comparing fluoride varnish with placebo, no active treatment or other fluoride preventive regimens of at least 2 years' study duration were included. The trials that met the inclusion criteria were assessed independently and systematically by at least two reviewers and scored from A to C according to predetermined criteria for methodology and performance. The main outcome measure was the preventive fraction expressed as a percentage. The results displayed limited evidence (evidence level 3) for the caries preventive effect of topical applications of fluoride varnishes in permanent teeth. The average prevented fraction was 30% (0–69%) when compared with untreated controls. Inconclusive evidence (evidence level 4) was found for fluoride varnish treatment in the primary dentition and in adults. This systematic review reinforces the need for future clinical research of high quality, incorporating modern concepts of clinical performance and evaluation to assess dental caries control using professional fluoride varnish.     

A review of sodium fluoride varnish

Fluoride varnish was incorporated into clinical dentistry to reduce caries; its use in the U.S. has increased progressively since it was approved by the FDA in 1994. This paper reviewed clinical studies and found that fluoride varnish's effectiveness in caries prevention, ease of application, and safety give it an advantage over other types of topical fluoride treatments (such as gels and rinses) or other caries management methods. As a result, it is regarded as one of the superior topical fluoride agents for young children.     

A cluster-randomized controlled trial: fluoride varnish in school children

We conducted a school-based parallel cluster randomized controlled trial with 36-month follow-up of children aged 7 to 8 years. Primary schools were randomly assigned to 2 groups: 3 applications of fluoride varnish (22,600 ppm) each year or no intervention. The primary outcome was DFS increment in the first permanent molars, with the hypothesis that 9 applications of varnish over 3 years would result in a lower increment in the test group. Follow-up measurements were recorded by examiners blind to the allocation. Ninety-five schools were randomized to the test and 95 to the reference groups; 1473 (test) and 1494 (reference) children participated in the trial. An intention-to-treat analysis was carried out with random effects models. The DFS increment was 0.65 (SD 2.15) in the test and 0.67 (SD 2.10) in the reference groups, respectively. There was no statistically significant difference between the groups. We were unable to demonstrate an effect for fluoride varnish when it was used as a public health intervention to prevent caries in the first permanent molar teeth (Inter-national Standard Randomized Controlled Trial Registration: ISRCTN: #72589426).     

Recommendations for fluoride varnish use in caries management

Available data suggest that fluoride varnish can be a safe and effective method for caries management. The application of varnish can be beneficial for those at risk for caries and for patients with special needs, and for those with no access to daily fluoride or other preventive methods. Even a small amount of varnish can be applied to active noncavitated lesions, assuring that a high concentration of the agent is available at the site where needed and that the total amount of active agent administered to the patient may be markedly reduced. Considering that varnish treatment is painless and can be easily performed by auxiliary dental personnel, it is a caries preventive method that can be easily applied and recommended for any age group, even young children. For high-risk caries patients with a significant cariogenic challenge, topical applications of fluoride might be insufficient and thus could be supplemented with other anticariogenic methods, such as xylitol chewing gum.     

Caries management with fluoride varnish of children in U.S

Fluoride varnish prolongs the contact time between fluoride and tooth surface to reduce caries. Its active ingredient is usually 5% sodium fluoride, or 22,600 ppm fluoride. Its use as an "off-label" approved drug for caries control in the United States has been on the rise, along with increasing evidence of its efficacy in case-based studies. It sets rapidly on teeth, and it is simple, quick and easy to apply. Side effects or complications of its use are rare. Gagging and swallowing are unusual. The risk of dental fluorosis is minimal. And it can be safely used in young children.     

Oral microflora in preschool children attending a fluoride varnish program: a cross-sectional study

Background

To compare the oral microflora in preschool children attending a fluoride varnish program with a reference group receiving a standard oral health program without fluoride varnish applications. A second aim was to relate the microbial composition to the caries prevalence.

Methods

Five hundred seven 3-year-old children were enrolled from a cohort of 3403 preschool children taking part in a community based oral health project. Two hundred sixty-three of them had attended caries-preventive program with semi-annual applications of a fluoride varnish since the age of 1 year (test group) while 237 had received standard preventive care (reference group). Oral samples were collected with a sterile swab and analysed with checkerboard DNA-DNA hybridization using 12 pre-determined bacterial probes. Caries and background data were collected from clinical examinations and questionnaires.

Results

Gram-positive streptococci (S. intermedius, S. salivarius, S. oralis) were most frequently detected and displayed the highest counts in both groups. There were no significant differences between the groups concerning prevalence of any of the selected bacterial strains except for S. oralis that occurred less frequently in the reference group. In children with caries, V. parvula were significantly more common (p?<?0.05) while strains of Lactobacillus, Bifidobacterium and Neisseria were more prevalent among the caries-free children (p?<?0.05).

Conclusions

A 2-year community program with semi-annual fluoride varnish applications did not seem to significantly influence the oral microflora in preschool children.

Trial registration

www.controlled-trials.com (ISRCTN35086887) 20131216 ‘retrospectively registered’.

     

Is fluoride varnish safe?: Validating the safety of fluoride varnish

BackgroundFluoride varnish is widely used in dentistry as a caries preventive measure with recommendations for its use even in infants. In addition, nondental providers are also applying varnish on children's teeth in various settings. However, there are questions from these nondental providers as to the safety of fluoride varnish.MethodsTo evaluate and describe the adverse events (AEs) related to fluoride varnish, the US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was used. AEs reported for the dental product code for “varnish, cavity,” “varnish,” and “fluoride” were evaluated. The identified AEs were then reviewed and categorized using appropriate key words for the various signs and symptoms, outcomes, and treatment.ResultsOver the 10-year period, only 65 AEs were reported for fluoride varnish products. Swelling (33.8%); burning, itching, or soreness (23.1%); and rash (16.9%) were the most common signs and symptoms reported. The most common site reported was the lips (27.7%). The most common outcome was that the patient was taken to the hospital (18.5%) or emergency department (15.4%). No deaths were reported. The patients were treated primarily using diphenhydramine (Benadryl, Johnson & Johnson Consumer) (26.1%), followed by an epinephrine autoinjector (EpiPen, Mylan) and other forms of epinephrine (15.4%), and prednisolone (9.2%). In 16.9% of the cases with AEs there was a history of allergies. The rate of AEs is estimated to be between 0.099 and 0.105 per million for fluoride varnish. A concern is the likelihood of underreporting AEs in the Manufacturer and User Facility Device Experience database.ConclusionsGiven the widespread use of fluoride varnish in the United States, the number of AEs reported to the US Food and Drug Administration were few. Thus fluoride varnish can be considered a safe dental product.Practical ImplicationsProvides data on the safety of fluoride varnish that can be used by the dental profession to allay concerns by nondental providers and patients on this important caries preventive measure.     

Effect of a fluoride varnish (Duraphat®) in preschool children

The caries-preventive effect of semiannual applications of a fluoride varnish (Duraphat) was tested for 2 years in 225 3-year-old children; 113 children served as a control group. At the baseline examination, 69% of the children in the test group and 75% in the control group were caries-free. The results after 2 years showed an average caries increment of 2.1 surfaces in the test group and 3.7 in the control group. The difference is statistically significant. Thirty-eight percent of the children in the test group and 27% in the control group were still caries-free. The caries reduction was 44%.     

Enamel fluoride uptake of a novel water-based fluoride varnish

Aim of the in situ-study was to evaluate fluoride retention in sound and demineralised enamel after application of a novel water-based fluoride (0.12% F) varnish Mirafluorid (Hager and Werken, Germany) compared to the resin-based varnish (2.26% F) Duraphat (Colgate, USA). Each five enamel specimens were prepared from 60 bovine incisors. In 150 of these specimens, incipient lesions were produced with acidic hydroxyethylcellulose (pH 4.8; 72 h), 150 specimens were not demineralised. The samples were equally (n=100) allotted to three groups (A: Mirafluord, B: Duraphat, and C: control). Each 80 specimens (40 demineralised and 40 sound) were varnished with either Mirafluorid or Duraphat or remained unfluoridated (controls). The other specimens were used for measuring base-line fluoride content of the respective tooth. Each six specimens (three demineralised and three sound) were fixed in intraoral appliances worn for 5 days by 10 volunteers in three series (A-C). During the experiment, the samples were brushed twice daily with fluoridated toothpaste. KOH-soluble and structurally bound fluoride (0-30 and 31-60 microm depth) was determined immediately, 1, 3 and 5 days after fluoridation. Fluoride uptake was calculated as compared to base-line content and statistically analysed. Immediately after fluoridation, uptake of KOH-soluble and structurally bound fluoride was similar for Mirafluorid and Duraphat in both demineralised and sound enamel. However, at day 1, 3 and 5 statistically significantly higher amounts of KOH-soluble and structurally bound fluoride were found in the samples treated with Duraphat. For Mirafluorid only the uptake for KOH-soluble fluoride and structurally bound fluoride in the first enamel layer (0-30 microm) of the demineralised samples was significantly higher compared to the controls (C). It is concluded that the novel fluoride varnish Mirafluorid deposits less KOH-soluble and structurally bound fluoride on both demineralised and sound enamel compared to Duraphat under in situ-conditions.     

氟化钠护齿剂在预防学龄前儿童乳牙龋齿中的疗效观察

目的:观察氟化钠护齿剂预防儿童乳牙龋齿的效果,为全面开展学龄前儿童涂氟防龋提供依据。方法:采取随机整群抽样方法,在上海市徐汇区抽取25所公办幼儿园3~4岁小班儿童共1140名作为研究对象,在儿童家长知情同意的情况下,本着自愿原则,将研究对象分为2组。涂氟组762名,每半年涂氟1次,连续2年共涂布4次;对照组378名,不做涂氟处理。对所有入组儿童进行口腔卫生指导,比较2组儿童患龋率、龋均、龋病发病率、新增龋均的情况,采用SAS 9.4软件包进行统计学分析。结果:2年后,对照组的患龋率、龋均、龋病发生率和新增龋均均显著高于涂氟组（P<0.05）。结论:在学龄前儿童中应用氟化钠护齿剂,能有效降低乳牙龋病发生率和新增龋均,值得在学龄前儿童中推广应用。     

氟化物涂膜体外释氟情况研究

作者研究氟化物涂膜在体外使用后氟化物的释放情况，发现涂膜对于其中的氟化物有一定的缓释作用，但这种缓释作用的速度并不均匀，以开始一分钟的释放速度最快，以后释放速度明显减２４小时涂膜释氟量约占其总含量３０％，由于这种缓释作用，可使局部环境中氟化物保持一定浓度，延长氟化物与釉质对接触时间，阻止羟磷灰玫瑰溶解，促进脱矿釉质的再矿化。     

Caries prevention with fluoride varnish in a socially deprived community

It has been suggested that specific preventive programs be developed for children with high caries risk. One possibility is to consider whole classes in socially deprived schools as caries-risk groups and perform an intensified preventive program for the entire class. OBJECTIVE: The purpose of this study was to evaluate the effectiveness of such a program which includes the application of a fluoride varnish (Duraphat). METHODS: The application of the varnish was offered three to four times a year in a community with low socio-economic status and a generally high caries level. Two hundred and sixty-nine children in six primary schools of Linden/Limmer, a district in Hannover, Germany, were allocated to a test or a control group. The test group received the fluoride varnish for 4 years whereas the control group received no professional fluoride application. DMFT was recorded at the beginning of the study and after 4 years. RESULTS: At the end of the study, children who had received a minimum of two fluoride applications per year showed a significantly lower caries increment in comparison with the control group (0.88 DMFT vs 1.39 DMFT, P < 0.05). CONCLUSIONS: It can be concluded that a minimum of two applications of the fluoride varnish Duraphat per year may be an effective measure in preventing caries in socially deprived children with high caries activity.     

Sealant and fluoride varnish in caries: a randomized trial

Little is known about the effect of discontinuation of sealant or fluoride varnish. The purpose of this study was to compare sealant with fluoride varnish in the prevention of occlusal caries in permanent first molars of children over a nine-year period: 4 yrs for program evaluation plus 5 yrs of discontinuation. A clinical trial was conducted on three groups of six- to eight-year-old schoolchildren: a control group (n = 45); a group (n = 37) in which sealant was applied and reapplied up to 36 mos; and a group (n = 38) in which fluoride varnish was applied and re-applied up to 42 mos. Percent caries reduction was studied in these initially healthy molars with complete occlusal eruption: 129 (control), 113 (sealant), and 129 (varnish) molars met inclusion criteria. Of these, 76.7%, 26.6%, and 55.8% had developed occlusal caries at 9 yrs, which implies caries reductions of 65.4% (SE = 8.5%) for sealants vs. control and 27.3% (SE = 10.2%) for varnish vs. control. Furthermore, the varnish program was not effective during the discontinuation period.     

Three-year caries increments after fluoride rinses or topical applications with a fluoride varnish

251 9-12-yr-old children completed a 3-yr, double-blind, clinical trial of two caries preventive fluoride programs. Caries increments and progression patterns were compared in two groups of children who rinsed every fortnight with a 0.2% NaF solution or received biannual topical applications with a fluoride varnish (Fluor-Protector). Clinically recorded mean DFS increments were 3.3 +/- 0.2 (SE) in the rinse group and 3.5 +/- 0.2 in the varnish group. In both groups nearly half of these increments were recorded in the occlusal surfaces of second molars. The mean incremental DFS recorded radiographically on approximal surfaces of posterior teeth were 1.1 +/- 0.2 and 1.5 +/- 0.2 in the rinse and varnish group, respectively. None of the inter-group differences were statistically significant (P greater than 0.05). Detailed analyses of the radiographic scores revealed a similar and extremely slow caries progression in the two study groups and they strengthened the conclusion of equal clinical efficacy of the two treatments. None of the fluoride programs had been able to change preestablished patterns of caries development among the children.     

氟化物涂膜的临床应用

氟化物的防龋作用较为明显，目前临床上应用的各种氟化物剂型多有其缺点，严重影响了氟化物的临床应用。氟化物涂膜作为一种局部应用氟化物缓释剂型，由于其独特的剂型特点，在防龋、治疗牙本质过敏症和预防正畸过程中牙釉质白斑的发生等多个方面都有着不可替代的优点，因此在许多国家氟化物涂膜已取代了氟化物凝胶的应用。本文就氟化物涂膜的临床应用情况及功能特点作一简要综述。