A review of sodium fluoride varnish

C.H. Chu, PhD, MAGD | Edward C.M. Lo, PhD, MDS

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. Received: December 20, 2005

Fluoride applications were incorporated into clinical dentistry in the 1940s to reduce dental caries.1 Many fluoride products (such as sodium fluoride gels and stannous fluoride solutions) are aqueous agents. A non-aqueous form of topical fluoride was developed to promote a longer retention time; in 1964, the literature reported that a 2% sodium fluoride lacquer in an alcoholic solution of natural resins was being used.2 This lacquer was a fluoride varnish, used to prolong the contact time between fluoride and enamel. The first clinical trial of fluoride varnish was published four years later and indicated that the product led to a significant effect in caries prevention.3 Since then, a number of clinical trials have been reported as the manufacture and application of fluoride varnishes has developed.4 The active ingredient of fluoride varnish usually is 5% sodium fluoride (NaF). The inactive ingredients in the varnish are there primarily for flavoring and to ensure that the fluoride sticks to the tooth surface. The most common ingredients usually include sodium saccharin (which is used as a sweetener), beeswax and ethanol (for the purpose of forming a gel-type structure to stabilize sodium ions), and shellac and mastic (to provide a flexible, permeable hard surface that prevents the varnish from dissolving rapidly in saliva). A flow enhancer such as kolophonium also is included. Duraphat (Colgate-Palmolive, Canton, MA; 800.763.0246), a 5% NaF preparation, was the first commercially available fluoride varnish. Although fluoride varnishes had been used widely in many countries for decades, the FDA did not

Accepted: April 13, 2006

approve the use of fluoride varnishes for dentistry in the United States until 1994. Three years later, Colgate began distributing Duraphat in tubes (containing 10 mL of varnish) for the United States. A number of clinical studies of Duraphat reported that the product was effective in preventing caries among children (see the table).5-10 At present, Duraphat is used in more than 40 countries.2 Other common fluoride varnishes include Fluor Protector (Ivoclar/Vivadent, Amherst, NY; 800.533.6825), Duraflor (Pharma Science, Montreal, Canada; 800.361.2862), CavityShield (OMNII Oral Pharmaceuticals, West Palm Beach, FL; 800.445.3386), Bifluorid 12 (Voco, Cuxhaven, Germany; 0.47.2.719.0) and Carex (Voss, Norway; 0.47.55.58.48.16). Fluor Protector is a difluorosaline agent that was introduced in the mid-1970s; a 1983 study claimed that Fluor Protector could result in a high fluoride uptake by enamel.11 Fluor Protector contains 0.7% fluoride in a polyurethane varnish and, unlike Duraphat, has acidic properties. It is available in 1.0 mL ampules and 0.4 mL single-unit doses. In the U.S., it is used in a 0.1% fluoride concentration and is marketed as a cavity varnish to seal and prevent the permeation of fluids and metal ions. Duraflor is a 5% NaF varnish that is available in 10 mL tubes. It includes xylitol (a sweetener) and bubblegum flavoring to increase patient acceptance. Reports have suggested it could prevent caries development and also could arrest caries progression.12,13 CavityShield contains 5% NaF in a neutral resin and is packaged in single-use doses of 0.25 mL and 0.4 mL. The fluoride

content is reported to be more uniform than that of Duraphat.14 An advertised advantage of CavityShield is that the unit dose can be mixed easily and applied to teeth, eliminating the concern of administering an unknown dose of fluoride. Bifluorid 12 contains both NaF (2.7% F) and calcium fluoride (CaF2) (2.9% F). A 1995 study reported that this CaF2/NaF varnish deposited more fluoride on the surface of demineralized enamel than NaF varnish alone.15 Carex was developed in Norway and contains 1.8% fluoride. A 1991 study indicated that Carex and Duraphat demonstrated a comparable efficacy among children.16 Another experimental fluoride varnish is an NaF-ethanol varnish called CDB. In 1990, Acuna et al reported that using this experimental varnish led to a high fluoride uptake in both the enamel and dentine of extracted human canine teeth.17 Sodium fluoride varnish is advocated for moderate and high-risk children, particularly children younger than 5, as well as for children who are receiving orthodontic treatment.18 It also is used to prevent and arrest caries in children.19 The manufacturer of Duraphat suggests using the product for preventing caries, promoting remineralization of caries, and treating tooth hypersensitivity. More than 90% of the municipal caries-preventive programs in Denmark provided fluoride varnish for children up to 18 years of age.20 However, children who are at low risk, are caries-free, and live in a fluoridated community may not require fluoride varnish for caries prevention.18 Sodium fluoride varnish can be applied topically two to four times a year. This regimen was the most common professionally applied fluoride measure in the Nordic countries for individuals at high risk for caries.5,9,21-24 Pienihakkinen and Jokela conducted a three-year clinical study with young children in Finland in which high-risk children received Duraphat four times a year for risk-based management of caries; this administration was determined to be effective and practical.25 As there are no consistent July-August 2006

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Caries Prevention

A review of sodium fluoride varnish

Table. Oral summary of clinical studies on the use of sodium fluoride in children. 5-10, 18,22-24, 55-74

Study Site Subjects Duration Teeth (year of publication) (months) Teeth present Erupted Chu et al (2002) Guang375 children 30 Unerupted zhou, (mean age = Impacted China 4.0 years) Missing teeth Congenitally Lost antemortem Florio et al (2001) Sao Paulo, 250 12 Lost postmortem Brazil children, 6 Tooth position years old Malposition Crown morphology Caries Attrition,etabrasion, erosion Zimmer al Hannover, 269 children 48 Atypical variations, enamel pearls, peg laterals, (1999) Germany (mean age =and so forth 7.1 years) Dentigenerous cyst Petersson et al Halland, 5,137 24 Root morphology (1998) Sweden children, Size aged 4–5 Shape Number Divergence of roots Dilaceration Root fracture Bravo et al (1997) Andalucia, 314 children, 24 Hypercementosis Spain aged 6–8 Root resorption Root hemisections Pulp chamber/root canal morphology

Intervention

Main findings

Group 1: Silver fluoride once/year; Group 2: Duraphat 4 x /year; Group 3: control

Groups 1 and 2 developed fewer new caries cases than Group 3 (p < 0.001); a statistically significant arrest of caries in Group 1 (p < 0.001)

Group 1: Vitremer sealant; Group 2: Duraphat 2x /year; Group 3: 0.2% NaF rinse weekly

Statistically significant inactivation of caries activity in Group 1 (p < 0.05); no statistically significant differences in caries progression among these groups

Duraphat vs. control; Duraphat 4 x /year

Test group showed a 37% caries reduction in decayed, missing, and filled teeth (DMFT) (p < 0.05)

Fluor Protector vs control; Fluor Protector twice a year

No statistically significant caries reduction in decayed fillings and surfaces in Fluor Protector group; 19–25% caries reduction in proximal lesions among Fluor Protector group (p < 0.05)

Group 1: Delton sealant; Group 2: Duraphat twice a year; Group 3: control

38% reduction in decayed, missing, and filled surfaces (DMFS) on permanent first molars in Duraphat group; 68% reduction in Delton sealant group (p < 0.01)

Seppa et al (1995)

Ylojarvi, Finland

254 children, aged 12–13

36

Group 1: APF gel 2x /year; Group 2: Duraphat 2x /year

No statistically significant caries reduction in DMFS between Duraphat and APF groups

Seppa et al (1994)

Kuopio, Finland


36

Group 1: Duraphat 3x /year; Group 2: diluted (50%) Duraphat 3x /year

No statistically significant caries reduction in DMFS between the two groups

Skold et al (1994)

Floda, Sweden


36

Group 1: Duraphat 3x /week, once a year; Group 2: Duraphat once a year

52% reduction in DMFS on permanent first molars in Group 1 (p < 0.001)

Peyearon et al (1992)

Malmo, Sweden

468 children aged 3–6

24

Duraphat (4 x /year) vs. control

Progression of proximal caries reduced 27% in the Duraphat group (p < 0.01)

Haugejorden and Nord (1991)

Voss, Norway


36

Group 1: Duraphat 2x /year; Group 2: Carex 2x /year

A comparable efficacy for Carex and Duraphat on posterior teeth

Petersson et al (1991)

Halmstad, Sweden

146 children, 11 years old

36

Group 1: Duraphat 3 times in one week once a year; Group 2: Duraphat 2x /year

Group 1 showed a 46% reduction in progression of proximal caries (p < 0.05)

Seppa and Tolonen, 1990

Kuopio, Finland


24

Group 1: Duraphat 4 x /year; Group 2: Duraphat 2x /year


248 General Dentistry

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Table. Oral summary of clinical studies on the use of sodium fluoride in children. 5-10, 18,22-24, 55-74 (continued from page 248)

Study (year of publication) Lindquist et al (1989)

Site

Subjects

Gothenburg, Sweden

189 children, 12–14 years old, with >106 S. Mutans/mL in saliva

Clark et al (1987)

Sherbrooke and Lac Megantic, Canada

Seppa and Pollanen (1987)

Duration (months) 24

Intervention

Main findings

Group 1: Chlorhexidine gel 4 x /year; Group 2: Duraphat 4 x /year; Group 3: ferric-aluminum fluoride 4 x /year

No statistically significant caries reduction in new decayed and filled surfaces for Duraphat and ferricaluminum fluoride; 51.7% caries reduction in chlorhexidine gel group, (p < 0.001)


56

Group 1: Fluor Protector 2x /year; Group 2: Durafluor 2x /year; Group 3: control

27% reduction in DMFS in the Durafluor group (p < 0.05); no statistically significant caries reduction in the Fluor Protector group

Kuopio, Finland


24

Group 1: Fluoride rinse biweekly; Group 2: Duraphat 2x /year; Group 3: Fluor Protector 2x /year

DMFS increment in Group 1 was significantly more than that in Group 2 (p < 0.01); DMFS increment in Group 3 was significantly greater than that found in Group 2 (p < 0.05)

Kirkegaard et al (1986)

Horsens, Denmark

248 children (mean age = 9.6 years)

60

Group 1: Duraphat 2x /year; Group 2: 0.2% NaF rinse biweekly

No statistically significant caries reduction between the two groups

Petersson et al (1985)

Uddevalla, Sweden


24

Group 1: fluoride tablet twice daily; Group 2: fluoride toothpaste; Group 3: Duraphat 2x /year; Group 4: fluoride toothpaste plus Duraphat 2x /year

No statistically significant caries reduction between groups

Klimek et al (1985)

Marburg, Germany


24

Group 1: Duraphat 2 times plus five prophylaxes/year; Group 2: control

Group 1 showed 46% caries reduction in DFS (p < 0.001)

Holm et al (1984)

Eslov, Sweden


24

Group 1: Duraphat 2x /year; Group 2: control

Duraphat group showed 56% reduction in fissure caries (p < 0.05)

Modeer et al (1984)

Huddinge, Sweden


36

Group 1: Duraphat 4 x /year; Group 2: control

Duraphat group showed caries reduction of approximately 24% in new decayed and filled surfaces (p < 0.05).

Tewari et al (1984)

Chandigarh, India

1,335 children, aged 6–12 (mean age = 8.5 years)

18

Group 1: NaF solution 2x/year; Group 2: AFP solution 2x /year; Group 3: Duraphat 2x /year; Group 4: control

Caries reduction of 33–40% for DMFT and DMFS in Group 2 (p < 0.05); Group 3 showed caries reduction of 71–72% in DMFT and DMFS (p < 0.0001)

van Eck et al (1984)

Alkmaar, Netherlands

152 children, 10–12 years old

36

Group 1: Fluor Protector 1x /year; Group 2: control


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Table. Oral summary of clinical studies on the use of sodium fluoride in children. 5-10, 18,22-24, 55-74 (continued from page 249)

Study (year of publication) Seppa et al (1983)

Site

Subjects

Kuopio, Finland

60 children with DMFS, aged 11–13

Grodzka et al (1982)

Warsaw, Poland

Seppa et al (1982)

Duration (months) 36

Intervention

Main findings

Split-mouth design; Duraphat 2x/year vs. control

Approximately 44% reduction in rate of caries progression for teeth with Duraphat (p < 0.001)

322 children, aged 3–4 years

24

Duraphat (twice a year) vs. control

No statistically significant caries reduction in either DMFS or DMFT between the two groups

Kuopio, Finland


36

Split-mouth design: Group 1: Duraphat 2x /year; Group 2: Fluor Protector 2x /year

Duraphat group reported 30% reduction of caries on DMFS (p < 0.001); no statistically significant caries reduction in the Fluor Protector group

Kolehmainen (1981)

Helsinki, Finland

163 children (mean age = 12.8 years)

24

Split month design: Fluor Protector (2x /year) vs. control

No statistically significant caries reduction for teeth with or without Fluor Protector treatment

Holm (1979)

Not stated


24

Duraphat vs control; Duraphat 2x /year

44% caries reduction in the Duraphat group (p < 0.05)

Koch et al (1979)

Varnamo, Sweden


24

Group 1: Duraphat 2x /year; Group 2: 0.2% NaF rinse biweekly

Duraphat group showed a 43% reduction in frank cavitation caries (p < 0.05) compared with a 29% reduction in proximal caries diagnosed with radiograph (p < 0.05)

Maiwald et al (1978)

Leipzig, Germany


24

Group 1: Duraphat once/year; Group 2: Duraphat 3x /year; Group 3: control

Group 1 saw no significant effect on caries incidence; Group 2 saw a 46% reduction in DMFT (p < 0.05)

Murray et al (1977)

Chesham, England


24

Split-mouth design: Duraphat (2x /year) vs. placebo (2x /year)

Teeth treated with Duraphat showed a 37% caries reduction in DMFS (p < 0.001)

Koch et al (1975)

Jonkoping, Sweden


12

Group 1: Duraphat twice/year; Group 2: control

Caries increment for Group 1 was 0.9, compared with 4.0 for Group 2 (p = 0.001)

Wegner (1976)

Putbus, Germany

87 diabetic children, 10 years old

24

Group 1: Duraphat twice/year; Group 2: control

Group 1 demonstrated a 54% caries reduction in DMFT (p < 0.05)

results of enhanced effectiveness of caries prevention with fluoride application every three months biannually, the frequency of sodium fluoride varnish application currently is under debate for cost-saving reasons.4 Even so, two applications of fluoride varnish per year is the schedule recommended most commonly, possibly because it matches the standard dental office schedule of two recall visits per year. 250 General Dentistry

Fluoride varnish mode of action The mechanism of fluoride action in dental caries still is being researched, although it has been reported that the concentrated fluoride ions in fluoride varnish cause globules of a calcium fluoride-like material to form on the tooth surface.26 These globules are stabilized by protein phosphate in the mouth and act as an insoluble reservoir of fluoride at neutral www.agd.org

pH. When there is a cariogenic challenge such as sugar consumption, the pH is lowered and the dissolution rate of these globules increases. This response lowers the solubility constant of calcium and phosphate ions, releasing fluoride and increasing the saturation of calcium and phosphate ions in plaque fluid as a result. This reaction helps to prevent the dissolution of calcium and phosphate from the tooth mineral and/or increases the rate

of remineralization or reprecipitation of the lost minerals. This mechanism can explain how topical application of a fluoride varnish two or three times a year can result in long-term caries reduction.26

Advantages and disadvantages of fluoride varnish Fluoride varnish offers the theoretical advantage of prolonged contact time, acting as a slow-releasing reservoir to prevent the immediate loss of fluoride after application.21 The varnish can be applied quickly and easily and sets rapidly on teeth; gagging and swallowing are unusual.27 The simplicity of its application makes it suitable for special-needs populations—including very young children, patients with autism, and patients with management problems (such as mental or physical disabilities)—as well as for outreach dental services. A professional prophylaxis before varnish application has no additional effect on its caries prevention property and thus is not necessary; as a result, the chairside application time of fluoride varnish is short.28 Application of fluoride varnish to four first molars may take less than half a minute. Warren et al reported that both patients and operators prefer fluoride varnish to fluoride gel.29 More importantly, Bowden’s 1998 study reported that fluoride varnishes are safe for young children.30 Compared with other types of topical fluoride treatments (such as gels or rinses) or other caries management methods, fluoride varnishes offer effective caries prevention, ease of application, and safety.4 A systematic review of caries management methods by Bader et al reported that fluoride varnish was “fair” at preventing dental caries, while the evidence for other methods, including sucrose-free gum and combined chlorhexidine-fluoride methods, was incomplete.31 In addition, a recent review by Petersson found an average preventive fraction of 30% (0–69%) of fluoride varnish in children.32 Fluoride varnishes have gained attention in terms of public health dentistry and it is likely that they will become the most common form of topical fluorides applied by dentists.30 One disadvantage of Duraphat is its poor esthetic effect. A yellow film of varnish remains on the teeth for several hours after application unless it is

removed by brushing; in addition, there is a temporary discoloration of teeth after varnish application.29 While the majority of patients find the presence of varnish on their teeth acceptable, it is the authors’ experience that some patients dislike its presence as a thin film on their teeth or they find the taste of the varnish objectionable.

Safety of fluoride varnish Duraphat varnish contains either a 5% NaF ion or 2.26% fluoride ion. It is considered to be a concentrated fluoride therapeutic agent delivered by dental professionals. Ingestion of excessive fluoride can be a hazard to patients (especially preschool children) who are receiving topical fluoride treatment. According to a fluoride toxicity report by Shulman and Wells, a child weighing 10 kg who ingests 50 mg of fluoride probably will have ingested a toxic dose.33 Roberts and Longhurst conducted a clinical evaluation on the amount of fluoride applied to children with Duraphat in the United Kingdom and found that the amount of fluoride applied on average was 5.2 mg per child; this amount varied little regardless of the children’s ages and no child received the level of fluoride ion quoted for toxicity.34 Fluoride varnish sets rapidly when applied to teeth and most of the sodium fluoride applied will stay on the tooth surfaces in the natural resins. A study of Swedish children by Ekstrand et al showed a plasma fluoride peak level of 3.2–6.3 μmol/L after fluoride varnish was applied.35 By contrast, a later study noted that a four-minute acidulated phosphate fluoride (APF) gel application produced a plasma fluoride peak of 16–76 μmol/L.36 By comparison, a 1983 study on preschool children reported that the mean plasma fluoride peak level after brushing with fluoride toothpaste was 3.6 μmol/L, while ingesting a 1.0 mg fluoride tablet produced a peak level of 4.5 μmol/L.37 Two cases of contact allergy to Duraphat varnish have been reported in the literature; the first caused dermatitis in a dental assistant’s hand, while the second caused stomatitis in a patient.38 It has been suggested that these allergic responses were related to the varnish’s colophony component.39 According to the manufacturer, edematous swelling

and vomiting by patients with sensitive stomachs have been reported as rare side effects.40 Recent reviews indicate that fluoride varnish is safe for dental care and that risk of acute toxic reactions from fluoride varnish is minimal.4,30,39 In addition, the risk of dental fluorosis is minimal because children are not exposed to fluoride varnishes as frequently as they are to fluoride supplements.4,39

Clinical studies of fluoride varnish on caries As the most commonly used fluoride varnish in dentistry, Duraphat has been the subject of many reviews.4,41-48 The table provides a summary of clinical studies concerning fluoride varnishes in children. In most clinical trials, Duraphat was reported to be effective for preventing caries, with an average reduction of approximately 30%.32 Meta-analysis has been conducted using a fitted fixed and a random effects model. The overall effect size of caries reduction was approximately 0.38 in both models.49,50 Fluor Protector deposited more fluoride in and on the enamel and protected the enamel more effectively in situ than Duraphat; however, it was not proven clinically to be more effective.43,46 Some studies found NaF more effective than difluorosaline, while others reported that both were equally effective at reducing caries.26 Topical application of a sodium fluoride varnish is carried out using a small brush and a very small amount of varnish (especially for young children). One study found that an average of 0.17 mL of Duraphat was used in each topical application.51 The teeth do not have to be very dry and the patient should not eat for approximately two hours after application.4 Since toothbrushing can remove fluoride varnish, the varnish should be left on the teeth and brushing on the day of application should be avoided whenever possible.4 In a two-year randomized study in Finland, Seppa and Tolonen studied 300 children at risk of caries and did not find any significant difference in the increment of caries experience between those who received two applications of sodium fluoride varnish per year and those who received four applications.52 The study also reported that children with a very July-August 2006

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high caries experience would not benefit from more frequent fluoride application. Conversely, Modeer et al investigated the progression of proximal caries lesions in premolars and molars using Duraphat varnish four times per year; they reported a significant caries reduction among their patient population of 194 teenagers.22 Ripa and Newbrun both recommended four applications of fluoride treatment a year for patients at high risk for caries.53,54

Summary Fluoride varnish can be an effective agent in caries management. Fluoride varnish is regarded as a superior topical fluoride agent for young children and there are several advantages to using it instead of other fluoride agents. The contemporary view of fluoride varnish is that it is simple to use, takes only a few seconds to apply, and is safe for children and other special needs groups.

Disclaimer The authors have no financial, economic, commercial, and/or professional interests with any of the products or manufacturers listed in this article.

Author information Dr. Chu is in charge of the dental unit, Health Service, University of Hong Kong, where Dr. Lo is a professor, Faculty of Dentistry.

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28. Seppa L. Effect of dental plaque on fluoride uptake by enamel from a sodium fluoride varnish in vivo. Caries Res 1983;17 71-75. 29. Warren DP, Henson HA, Chan JT. Dental hygienist and patient comparisons of fluoride varnishes to fluoride gels. J Dent Hyg 2000;74:94-101. 30. Bawden JW. Fluoride varnish: A useful new tool for public health dentistry. J Public Health Dent 1998;58:266-269. 31. Bader JD, Shugars DA, Bonito AJ. Systematic reviews of selected dental caries diagnostic and management methods. J Dent Educ 2001;65:960-968. 32. Petersson LG, Twetman S. Dahlgren H, Norlund A, Holm AK, Nordenram G, Lagerlof F, Soder B, Kallestal C, Mejare I, Axelsson S, Lingstrom P. Professional fluoride varnish treatment for caries control: A systematic review of clinical trials. Acta Odontol Scand 2004;62:170-176. 33. Shulman JD, Wells LM. Acute fluoride toxicity from ingesting home-use dental products in children, birth to 6 years of age. J Public Health Dent 1998;57:150-158.

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38. Isaksson M, Bruze M, Bjorkner B, Niklasson B. Contact allergy to Duraphat. Scand J Dent Res 1993;101:49-51. 39. Beltran-Aguilar ED, Goldstein JW, Lockwood SA. Fluoride varnishes. A review of their clinical use, cariostatic mechanism, efficacy and safety. J Am Dent Assoc 2000;131:589-596. 40. Duraphat [package insert]. Canton, MA: Colgate-Palmolive;2003. 41. Clark DC. A review on fluoride varnishes: An alternative topical fluoride treatment. Community Dent Oral Epidemiol 1982; 10:117-123. 42. Seppa L. Fluoride varnishes in caries prevention. Proc Finn Dent Soc 1982;78 Suppl 8:1-50. 43. Seppa L. Studies of fluoride varnishes in Finland. Proc Finn Dent Soc 1991;87:541547. 44. Yanover L. Fluoride varnishes as cariostatic agents: A review. J Can Dent Assoc 1982;48:401-404. 45. Primosch RE. A report on the efficacy of fluoridated varnishes in dental caries prevention. Clin Prev Dent 1985;7:12-22. 46. de Bruyn H, Arends J. Fluoride varnishes— A review. J Biol Buccale 1987;15:71-82. 47. Petersson LG. Fluoride mouthrinses and fluoride varnishes. Caries Res 1993;27 Suppl 1:35-42.

operator-, and self-applied gels) in an era of decreased caries and increased fluorosis prevalence. J Public Health Dent 1991;51:23-41.

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54. Newbrun E. Current treatment modalities of oral problems of patients with Sjogren’s syndrome: Caries prevention. Adv Dent Res 1996;10:29-34.

66. van Eck AA, Theuns HM, Groeneveld A. Effect of annual application of polyurethane lacquer containing silanefluoride. Community Dent Oral Epidemiol 1984;12:230-232.

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