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PubMed1987

Effect of fluoride containing dentifrice, mouthrinsing, and varnish on approximal dental caries in a 3-year clinical trial.

The purpose of this study was to evaluate the separate effect of fluoride dentifrice, fluoride mouthrinsing and fluoride varnish on approximal dental caries. All 252 13-14-yr-old children at an elementary school were selected at random and divided among four groups for a 3-yr longitudinal study. Group 1 received a fluoride dentifrice for home care and a fluoride mouthrinse once a week. Group 2 received a fluoride dentifrice for home care and a placebo mouthrinse once a week. Group 3 received a fluoride dentifrice for home care and a fluoride varnish once every 3 months. Group 4 received a placebo dentifrice for home care and a fluoride rinse once a week. Fluoride rinsing did not give any additional effect compared with placebo-rinsing when a fluoride dentifrice was used for home care. Fluoride varnish gave a significant caries reduction compared with fluoride rinsing.

Adolescent↗
PubMed1990

Effects of fluoride on caries development and progression in vivo.

The dissolution rate of calcium-fluoride-like material from the enamel surface in vivo appears to be much slower than previously thought. This could be due to adsorption of phosphate ions and/or protein molecules to the surface of the calcium-fluoride-like particles. During cariogenic challenges, the phosphate/protein coating is released, resulting in increased solubility rate of the calcium-fluoride-like material. Due to this mechanism, calcium-fluoride-like material may be a major aspect of the cariostatic mechanism of topically applied fluoride. Topically applied neutral fluoride agents are able to inhibit caries development in enamel but not completely stop lesion development. A fluoride solution at low pH has been found to be more effective in caries model studies than neutral fluoride agents, which might be due to the formation of a larger depot of calcium fluoride. Data from fluoridated areas indicate that the fluoride ion as such has a limited effect on lesion development, and a major mechanism of the cariostatic effect may be reformation of apatite (remineralization). The product of lesion consolidation (a fluoridated apatite) may have a limited effect, since intra-oral caries model studies show that even pure fluorapatite, in the form of shark enamel, demineralizes. In fissures and around orthodontic appliances, conventional fluoride agents appear to have only a small effect.

Calcium Fluoride↗
PubMed2003

History of water fluoridation.

Fluoride, the milestone element of pediatric dentistry, as well as modern dentistry, has been utilized for the last six decades in practice. Researchers all over the world have used fluoride in several forms in the prevention of tooth decay. Today, we are aware that most of this work has involved clinical research with children. It is particularly pertinent that the subject be adequately presented in the field of pediatric dentistry. In 1940's and 1950's were the years of ten-year studies, where caries reductions were first described. The industry of systemic fluoridation, public campaigns and advertisements became popular mostly in western world in 1960's and 1970's. The fluoridated dentifrices and changes of dentifrice formulations were established in 1980's. Many stated that children should receive one form of systemic fluoride and appropriate forms of topical fluoride in 1990's. Analyses showed that maximum protection against caries is obtained when teeth erupt into an environment with low concentrations of ionic fluoride. The similarity in caries reductions obtained in water fluoridation studies and long-term studies with topically administered fluoride regimens, including fluoride-containing dentifrices, indicates that the pre-eruptive effect of fluoride is of borderline significance relative to the more significant post-eruptive effect. It has taken a long time to show that water fluoridation and topical fluoride programs were thus important measures for the control of caries at the community level. Today, we are aware of the fact that the trio of diet, dentifrice and supplementation should exceed the optimal levels.

Americas↗
PubMed1975

Fluoride studies in Malaysia.

Twenty-four-hour urine samples and whole deciduous teeth from fluoridated (0.71 ppm) and non-fluoridated (0.14 ppm) areas together with some selected local food items were analysed for their fluoride content. The mean values for urinary fluoride were 0.90 ppm or 0.77 mg per day for the fluoridated area and 0.50 ppm or 0.52 mg per day for the non-fluoridated area. Assuming that half of all the fluoride ingested is excreted in the urine, this study suggests that the average daily fluoride intakes by adults in the fluoridated and non-fluoridated areas were about 1.5 mg and 1 mg respectively. The mean fluoride content of non-carious deciduous teeth from the fluoridated area was 416.89 ppm compared to 178.45 ppm in the low fluoride area.

Child↗
PubMed2005

Fluoride metabolism when added to salt.

The purpose of this review is to present the general characteristics of the metabolism of fluoride particularly as it occurs when ingested with fluoridated salt. Following the absorption of salt-borne fluoride from the stomach and intestines, its metabolism is identical to that of water-borne fluoride or other vehicles containing ionized fluoride. Because fluoridated salt is almost always ingested with food, however, absorption from the gastrointestinal tract may be delayed or reduced. Reports dealing with this subject have shown that fluoride absorption is delayed and, therefore, peak plasma concentrations are lower than when fluoride is ingested with water. The amount of ingested fluoride that is finally absorbed, however, is not appreciably affected unless the meal is composed mainly of components with high calcium concentrations. In this case, the extent of absorption can be reduced by as much as 50%. Fluoridated salt is also ingested less frequently than fluoridated water. Data are presented to show that the dose size and frequency of ingestion have only minor effects on fluoride retention in the body and on the concentrations in plasma, bone and enamel. Finally, calculations are presented to show that the risk of acute toxicity from fluoridated salt is virtually non-existent.

Absorption↗
PubMed2005

Cost aspects of salt fluoridation.

The cost of salt fluoridation in a given country depends primarily on the number of salt factories and on the technical level available in the country. Equipment required may cost U.S. dollars 400,000 for large plants producing at least 20,000 tons/year providing salt for populations of several millions. Reliable batch mixers have been built locally for U.S. dollars 3000 to U.S. dollars 10,000, with one such mixer capable of producing 10 batches of one metric ton/day or 2000 to 3000 tons a year for a population of 350,000 to 500,000. Frequently 85-90% of the costs are devoted to infrastructure; in combination with salt iodization, the cost for fluoride equipment is 30-50% less. loIization is promoted by WHO, UNICEF, other international organizations and national aid agencies which can indirectly support salt fluoridation. With respect to running costs, the expense for the fluoride chemical is the major factor in small plants producing for example 6000 tons of salt, i. e U.S. dollars 0.015 to 0.03 per year and capita. The cost for personnel necessary for addition of fluoride and quality control is approximately U.S. dollars 0.008/capita/year in small plants and even less in large ones. With adequate implementation, salt fluoridation affords a cariostatic effectiveness equal to that of water fluoridation. When its cost is compared to that of water fluoridation, there may not be much difference regarding initial cost for equipment except in the case of small salt factories where local production of batch mixers may lower initial expenses substantially. Running costs for salt fluoridation are 10 to 100 times lower because the amount of fluoride chemical needed and its handling are up to 100 times less than with water fluoridation. In practice, the cost of salt fluoridation is often so low that many producers did not raise the price of fluoridated salt; this has been the case in Switzerland since 1955 and also in several countries in the Americas today.

Americas↗
PubMed1990

Fluoride in dental plaque after a single toothbrushing with monofluorophosphate dentifrice.

Many studies have shown that topical fluoride applications can produce a fluoride reservoir in dental plaque. Since the most common topical fluoride application is via toothbrushing with fluoridated dentifrices, the aim of this study was to measure fluoride uptake by dental plaque after a single toothbrushing with monofluorophosphate (MFP) toothpaste and to follow the plaque until its fluoride concentration returned to the prebrushing levels. In a fluoridated area, plaque samples were collected from 26 children who brushed with MFP toothpaste, 22 children who brushed with a fluoride-free control toothpaste, before brushing and at intervals of 10 minutes, 1 hour and 2 hours after brushing. A combination fluoride electrode was used to determine the fluoride content of the samples. In conclusion, our study has shown that brushing with fluoridated water has a positive effect on the fluoride level of the plaque and the addition of MFP did not make a significant change, although it had a short term effect. A negative correlation was established between plaque wet weight and its fluoride content whenever the plaque equilibrated.

Adolescent↗
PubMed1989

[Fluoride poisoning: mechanism, symptoms and treatment].

The use of fluorides in doses recommended by the International Dental Association is totally safe. Fluoride toxicity occurs only when these doses are exceeded. The human organism is capable of metabolizing fluoride when administered in low doses. Toxic doses though can cause signs and symptoms which vary from simple gastric disturbances to serious health problems or even death. The least fluoride dose which can cause signs and symptoms of fluoride poisoning is called possibly toxic dose. In the present paper the amount of 5 mgF-/kg is considered as the probably toxic dose of fluoride. In the case of accidental ingestion of a fluoride overdose the dentist should be also to calculate the amount of fluoride ingested. A simple method of calculating the amount of fluoride swallowed is presented in this paper. In addition the emergency treatment for fluoride overdoses is discussed. The danger of acute fluoride poisoning has increased lately, especially for children, due to the variety, pleasant taste smell and colour of fluoride products. Dentists should be able to estimate the toxic potential of fluoride in case of accidental poisoning and advise appropriate treatment.

Drug Overdose↗
PubMed1982

Crystallinity, solubility, and dissolution rate behavior of fluoridated CO3 apatites.

To study the effect of fluoride on the physicochemical properties of carbonate-containing apatites, two series of fluoridated CO3 apatites with various fluoride contents were synthesized at 80 degrees C and pH 7.4. The alpha-axis dimensions of these apatites decreased with the increase of both fluoride and carbonate contents. The crystallinity of the apatites showed similar patterns of variation with the degree of fluoridation irrespective of carbonate content. These patterns appear analogous to the complex pattern of the fluoridated hydroxyapatites previously reported. In contrast to this unexpected crystallinity phenomena, the apparent solubility of fluoridated CO3 apatites in acetate buffer solutions at pH 4.0 and 6.0 and 37 degrees C decreased monotonically with increasing degree of fluoridation and approached that of fluoridated hydroxyapatites at high fluoride content. Dissolution rate of fluoridated CO3 apatite pellets at pH 4.0 also showed a simple decrease with increasing degree of fluoridation and was extremely sensitive to acid at low fluoride content.

Apatites↗
PubMed1995

Gramine and free amino acids as indicators of fluoride-induced stress in barley and its consequences to insect herbivory.

Barley leaves were sprayed with aqueous NaF, which caused accumulation of fluoride in the foliage, but no visible symptoms were detectable. No significant correlation was observed between foliar fluoride concentration and content of the indole alkaloid gramine after exposure to fluoride levels of 20 to 60 mg F liter-1. Fluoride exposure did not explicitly affect the performance of Carausius morosus or Rhopalosiphum paid on barley. After exposure to fluoride levels of 100 and 200 mg F liter-1, as NaF, fluoride treatment had a significant effect on gramine concentration of the first leaf of barley, being highest at a fluoride treatment of 200 mg liter-1, and there was a slight, but significant positive correlation between the log-transformed foliar fluoride concentration and log-transformed gramine concentration of the first leaf. Fluoride treatment increased levels of some individual free amino acids in barley foliage. Exposure of young barley to NaF in aqueous form caused accumulation of fluoride in barley foliage and resulted in increased levels of gramine in the first leaf and levels of some free amino acids in foliage. It is possible that the fluoride-induced concurrent increase in gramine concentration in barley leaves could override the eventual increase in nutritive value to herbivorous insects after fluoride exposure. More detailed biochemical studies of the induction of gramine production are needed to understand the fluoride effects in secondary metabolism of barley.

Alkaloids↗
PubMed1995

Endemic fluorosis in San Luis Potosi, Mexico. I. Identification of risk factors associated with human exposure to fluoride.

In order to identify risk factors associated with human exposure to fluoride in San Luis Potosi (SLP), Mexico, a biochemical and epidemiological study was carried out in 1992. Results from the analysis of fluoride sources showed that 61% of tap water samples had fluoride levels above the optimal level of 0.7-1.2 ppm. The levels were higher after boiling. In bottled water, fluoride levels ranged from 0.33 to 6.97 ppm. These sources are important since in SLP 82% of the children drink tap water, 31% also drink bottled water, 92% prepare their food with tap water, 44% boiled all the drinking water, and 91% used infant formula reconstituted with boiled water. The prevalence and severity of dental fluorosis in children (11-13 years old) increased as the concentration of water fluoride increased. At levels of fluoride in water lower than 0.7 ppm a prevalence of 69% was found for total dental fluorosis, whereas at levels of fluoride in water higher than 2.0 ppm a prevalence of 98% was found. In the same children, fluoride levels in urine were quantified. The levels increased as the concentration of water fluoride increased. Regressional analysis showed an increment of 0.54 ppm (P < 0.0001) of fluoride in urine for each ppm of fluoride in water. Fluoride urinary levels were higher in samples collected during the afternoon (1800) when compared with sample collected during the morning (1100). Taking together all these results, three risk factors for human exposure to fluoride in SLP can be identified: ambient temperature, boiled water, and food preparation with boiled water. These factors explain the prevalence of dental fluorosis in SLP.

Adolescent↗
PubMed1996

Developmental toxicity evaluation of sodium fluoride administered to rats and rabbits in drinking water.

Sodium fluoride (NaF; Cas No. 7681-49-4) is used in fluoridating municipal water supplies, resulting in chronic exposure of millions of people worldwide. Because of a lack of pertinent developmental toxicity studies in the literature, sodium fluoride was administered ad libitum in deionized/filtered drinking water (to mimic human exposure) to Sprague-Dawley-derived rats (26/group) on Gestation Days (GD) 6 through 15 at levels of 0, 50, 150, or 300 ppm and New Zealand White rabbits (26/group) on GD 6 through 19 at levels of 0, 100, 200, or 400 ppm. Higher concentrations via drinking water were not practicable due to the poor palatability of sodium fluoride. Drinking water (vehicle) contained less than 0.6 ppm sodium fluoride (limit of detection) and sodium fluoride content of the feed was 12.4 ppm fluoride (rats) and 15.6 ppm fluoride (rabbits). Maternal food, water, body weights, and clinical signs were recorded at regular intervals throughout these studies. Animals were killed on GD 20 (rats) or 30 (rabbits) and examined for implant status, fetal weight, sex, and morphological development. In the high-dose group of both studies there was an initial decreased maternal body weight gain which recovered over time and a decreased water consumption--attributed to decreased palatability. No clear clinical signs of toxicity were observed. Maternal exposure to sodium fluoride during organogenesis did not significantly affect the frequency of postimplantation loss, mean fetal body weight/litter, or external, visceral or skeletal malformations in either the rat or the rabbit. The NOAEL for maternal toxicity was 150 ppm sodium fluoride in drinking water (approximately 18 mg/kg/day) for rats, and 200 ppm (approximately 18/mg/kg/day rabbits. The NOAEL for developmental toxicity was > or = 300 ppm sodium fluoride (approximately 27 mg/kg/day) for rats and > or = 400 ppm (approximately 29 mg/kg/day) for rabbits administered during organogenesis in drinking water. The total exposure to fluoride (mg F/kg body weight/day from food and drinking water combined) in the mid- and high-dose groups for both species was > 100-fold higher than the range at 0.014-0.08 mg F/kg/day estimated for a 70-kg person from food and fluoridated (1 ppm) drinking water.

Animals↗
PubMed1995

A physiologically based pharmacokinetic model for fluoride uptake by bone.

A sex-specific, physiologically based pharmacokinetic (pbpk) model has been developed to describe the absorption, distribution, and elimination of fluorides in rats and humans. Growth curves generated by plotting mean body weights (kg) against age (weeks or years) are included in the simulation model to allow the integration of chronic fluoride exposure from birth to old age. The model incorporates age and body weight dependence of the physiological processes that control the uptake of fluoride by bone and the elimination of fluoride by the kidneys. Six compartments make up the model. These are lung, liver, kidney, bone, and slowly and rapidly perfused compartments. The model also includes two bone subcompartments: a small, flow-limited, rapidly exchangeable surface bone compartment and a bulk virtually nonexchangeable inner bone compartment. The inner bone compartment contains nearly all of the whole body content of fluoride, which, in the longer time frame, may be mobilized through the process of bone modeling and remodeling. The model has been validated by comparing the model predictions with experimental data gathered in rats and humans after drinking water and dietary ingestion of fluoride. This physiological model description of absorption, distribution, and elimination of fluoride from the body permits the analysis of the combined effect of ingesting and inhaling fluorides on the target organ, bone. Estimates of fluoride concentrations in bone are calculated and related to chronic fluoride toxicity. The model is thus useful for predicting some of the long-term metabolic features and tissue concentrations of fluoride that may be of value in understanding positive or negative effects of fluoride on human health. In addition, the pbpk model provides a basis for across-species extrapolation of the effective fluoride dose at the target tissue, bone, in the assessment of risk from different exposure conditions.

Adult↗
PubMed1997

Fluoride treatment increased serum IGF-1, bone turnover, and bone mass, but not bone strength, in rabbits.

We hypothesized that fluoride partly acts by changing the levels of circulating calcium-regulating hormones and skeletal growth factors. The effects of oral fluoride on 24 female, Dutch-Belted, young adult rabbits were studied. The rabbits were divided into two study groups, one control and the other receiving about 16 mg fluoride/rabbit/day in their drinking water. After 6 months of fluoride dosing, all rabbits were euthanized and bone and blood samples were taken for analyses. Fluoride treatment increased serum and bone fluoride levels by over an order of magnitude (P < 0.001), but did not affect body weight or the following serum biochemical variables: urea, creatinine, phosphorus, total protein, albumin, bilirubin, SGOT, or total alkaline phosphatase. No skeletal fluorosis or osteomalacia was observed histologically, nor did fluoride affect serum PTH or Vitamin D metabolites (P > 0.4). BAP was increased 37% (P < 0.05) by fluoride; serum TRAP was increased 42% (P < 0.05); serum IGF-1 was increased 40% (P < 0.05). Fluoride increased the vertebral BV/TV by 35% (P < 0.05) and tibial ash weight by 10% (P < 0.05). However, the increases in bone mass and bone formation were not reflected in improved bone strength. Fluoride decreased bone strength by about 19% in the L5 vertebra (P < 0.01) and 25% in the femoral neck (P < 0. 05). X-ray diffraction showed altered mineral crystal thickness in fluoride-treated bones (P < 0.001), and there was a negative association between crystal width and fracture stress of the femur (P < 0.02). In conclusion, fluoride's effects on bone mass and bone turnover were not mediated by PTH. IGF-1 was increased by fluoride and was associated with increased bone turnover, but was not correlated with bone formation markers. High-dose fluoride treatment did not improve, but decreased, bone strength in rabbits, even in the absence of impaired mineralization.

Acid Phosphatase↗
PubMed1996

Absence of detrimental effects of fluoride exposure in diabetic rats.

This study is part of a comprehensive programme to investigate fluoride toxicity and the hypothesis that fluoride ingested by "medically compromised' animals will result in altered physiological function. Its objectives were to monitor fluoride retention, tissue fluoride concentrations and genetic variables in diabetic and control rats chronically exposed to fluoride, and to determine whether or not adverse effects occurred. Male, Zucker fatty diabetic rats and Zucker age-matched lean controls were fed a low-fluoride diet ( < 1.2 parts/10(6) F-) ad libitum and received 0, 5, 15 or 50 parts/10(6) fluoride in their drinking water for 3 or 6 months. Fluoride metabolic balance was determined for 4 days before the end of each study phase. Plasma and urine were analysed for biochemical markers of tissue function, and plasma, urine, faeces and tissues were analysed for fluoride. Bone marrow cells from animals killed after 6 months of treatment were examined for frequency of sister chromatid exchange, a marker of genetic damage. The diabetic rats consumed, excreted and retained significantly greater amounts of fluoride than the controls (p < 0.05). There were dose-related increases in fluoride excretion, retention and tissue concentrations in both classes of animals, which were significantly greater in the diabetic rats. In spite of greater amounts of fluoride in the tissues of diabetic animals, there was no evidence, under these experimental conditions, that any of the fluoride exposures tested caused measurable adverse effects on the physiological, biochemical or genetic variables that were monitored.

Analysis of Variance↗
PubMed2005

Effect of a neutral citrate solution on the fluoride release of conventional restorative glass ionomer cements.

OBJECTIVES: This study investigates the effect of a neutral citrate solution on the fluoride release of 10 acid-base setting glass ionomer cements during 140 days at 37 degrees C. METHODS: Five disks of 10 acid-base setting restorative glass ionomers were prepared according to the manufacturer's instructions. These specimens were immersed individually in 25 ml of a 0.01 mol/l citrate solution with pH = 7. Over 140 days, the solutions were regularly renewed and the fluoride concentration eluted during each period was determined with a combined fluoride ion selective electrode. RESULTS: The cumulative fluoride release was the result of an initial high release that ceased after some time and a long-term of low fluoride release. The long-term fluoride release was higher in neutral citrate solution than in water. For some formulations the short-term fluoride release also was higher in neutral citrate solution than in water suggesting that the polysalt matrix composition could be important in this respect. SIGNIFICANCE: The fluoride release process is due not only to a loss of relatively loosely bound fluoride in the cement matrix, but also to the release of strongly bounded fluoride inducing a long-term fluoride release. The effect of citrate on the fluoride release process may increase depending on the acid (polyacrylic acid versus copolymers of polyacrylic acid) used for the polysalt formation in the hardening cement. Depending on the competition between the polyacrylate anion and the citrate anion for the metal cation extraction the fluoride release process may be retarded.

Cariostatic Agents↗
PubMed2006

Effects of fluoride emissions on two tropical grasses: Chloris gayana and Panicum maximum cv. Colonião.

In order to detect early effects of plant contamination by fluoride emission on two tropical grasses, Chloris gayana and Panicum maximum, previously cultivated under greenhouse conditions, were exposed to a single source of fluoride emission at a station at 1.1 km from an aluminum smelter in Ouro Preto, MG, Brazil. Controls were placed at a reference station 78km from the fluoride source. During an 8-day period of exposure leaf injury, ionic permeability, photosynthetic rates, stomatal conductance, transpiration, chlorophyll a fluorescence and chlorophyll, soluble carbohydrates and fluoride contents were evaluated. Plants at the Ouro Preto station showed an increase in fluoride content, leaf injury and ionic permeability. Symptoms of injury by fluoride exposure were visible after 3-4 days in both species. High electrolyte leakage and correlation coefficients between the total ionic permeability and the fluoride content in leaves indicate a fluoride effect on the structural and/or functional integrity of the cellular membranes. Leaf fluoride injuries were quite different in the two species. In C. gayana necroses were limited to the leaf tips, while in P. maximum damages were observed in the whole leaf, suggesting a higher susceptibility of this latter species to fluoride. Nonetheless, neither grass showed statistical differences with respect to photosynthetic rates, stomatal conductance, transpiration, chlorophyll a fluorescence and chlorophyll content in leaves without any apparent fluoride injury. Plants at the Ouro Preto station showed a significant decrease in reducing sugar content between 3 and 5 days of exposure to fluoride, but thereafter reducing sugar content increased reaching the content of control plants. Fluoride exposed plants also showed a remarkable starch content reduction, remaining always much lower than those at the reference station.

Air Pollutants↗
PubMed2006

Clinical evaluation of the intraoral fluoride releasing system in radiation-induced xerostomic subjects. Part 2: Phase I study.

Radiation-induced xerostomia can result in the rapid onset and progression of dental caries in head and neck cancer patients. Topically applied fluorides have been successfully used to inhibit the formation of dental caries in this population. However, because intensive daily self-application is required, compliance is an issue. The intraoral fluoride-releasing system (IFRS) containing a sodium fluoride core is a newly developed, sustained-release, passive drug delivery system that does not require patient involvement except for periodic replacement, thus reducing the effect of patient compliance on its effectiveness in dental caries prevention. Twenty-two head and neck cancer patients from U. T. M. D. Anderson Cancer Center, with radiation-induced xerostomia, were entered into a pilot study to contrast the daily home use of a 0.4% stannous fluoride-gel-containing tray (control group) to IFRS (study group) with respect to tolerability and adherence, and to obtain information on relative caries preventive efficacy. Participants were stratified on the basis of radiation exposure and randomly assigned to treatment with either IFRS or stannous fluoride gel. Patients in both groups were fitted with two IFRS retainers and also were instructed to use a 1100-ppm fluoride conventional sodium fluoride dentifrice twice daily. The study was conducted as a single-blinded, parallel-cell trial. Pre-existing carious lesions were restored prior to the beginning of the study. The efficacy variable was determined by the mean number of new or recurrent decayed surfaces. Patients were examined for caries 4, 8, 12, 24, 36, and 48 weeks after initiation of treatment. Reports of adverse reactions were based on information volunteered by patients and that were elicited during interviews. At baseline, the resting and stimulated salivary flow rates (g/5min) were significantly greater in the control group than in the study group (p<0.05). Patients in the control group had received significantly more radiation than those in the test group (68Gy vs. 60Gy; p=0.047). No marked differences in follow-up new and recurrent caries were found between the stannous fluoride gel control and IFRS groups during the study period. The rate of new or recurrent carious lesions in the group treated with the fluoride gel was slightly lower than in the IFRS group, based on carious lesions at the baseline examination (Poisson mean number of new or recurrent carious lesions for the control group=0.55 per year vs. 0.83 per year for the study group, p=0.705; odds ratio of the occurrence of any new or recurrent caries during follow-up for control group vs. the study group=0.80; p=0.781). This pilot study revealed that the IFRS was well-tolerated and safe in this study population associated with minimal complications during the duration of this study and was comparable in efficacy to a SnF(2) gel in preventing caries development. The IFRS provided similar rates of control for caries formation to a fluoride-gel-containing tray. The IFRS is designed to release a daily dose of 0.12mg of sodium fluoride, which can be evenly distributed throughout the oral cavity for a single application of 4 months. It would be more convenient than the daily home application of a tray of 0.4% stannous fluoride or 1.1% sodium fluoride gel, and avoids the problem of variable patient compliance.

Administration, Topical↗