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[New recommendations concerning the fluoride content of toddler toothpaste - consequences for systemic application of fluoride].

A group of experts from 4 European countries who gathered at a convention at Basel in November 1998, arrived at the recommendation to increase the fluoride (= F) content of toddler toothpastes from 250 ppm to 500 ppm. It was recommended to make parents brush the children's teeth with a pea-size piece of this toothpaste once a day, starting when the first deciduous teeth were erupting. Routine application of F-tablets would no longer be routinely prescribed, but restricted to individual indications in special high caries risk cases. This recommendation did not consider previous ones and was based exclusively on new scientific, mainly epidemiological evidence. In April 2000 the recommendation was officially issued by the German scientific dental association DGZMK.A careful case-control study resulted in the analysis of the risk to develop mottling of enamel under the influence of fluoridated water (1 ppm F) and fluoride toothpaste (1000 ppm F) when used in early childhood. It was found that excessive use of the fluoride toothpaste doubled the fluorosis risk, whereas when fluoride supplements (tablets, drops) were given the risk was about 20 times higher than without a fluoride supplement. Experiments in Germany and the Netherlands had shown that remineralisation of enamel under influence of 500 ppm F is achieved much more quickly than under application of 250 ppm F. A panel of WHO experts came to the conclusion that there was no evidence for the effectiveness of toothpastes containing less than 500 ppm. Statistics from the Netherlands have shown that the amount of fluoride tablets sold there is barely sufficient for the use by a quarter of all children 0 to 4 years old. In contrast to this low level of acceptance of fluoride tablets, fluoride toothpastes is widely accepted. It is their extensive use which explains the marked improvement of dentitions among the youth in this country during the last 20 years; the influence of topical fluoride gels, varnishes and other preventive measures was much less, and a reduction of sugar consumption (by the way less than 10 % of what it was in 1970) seems to have been the least important factor. The new recommendations based on topical rather than systemic fluoride application are better for preventive, toxicological, psychological and didactic reasons and should be implemented as soon as possible.

Administration, Oral↗

Betaine-containing toothpaste relieves subjective symptoms of dry mouth.

Subjects with dry mouth often experience irritation of the oral mucosa when using sodium lauryl sulfate containing products for oral hygiene. Betaine, or trimethylglycine, reduces skin-irritating effects of ingredients of cosmetics such as sodium lauryl sulfate. The aim of the present study was to compare the effects of a betaine-containing toothpaste with a regular toothpaste on the oral microbial flora, the condition of the oral mucosa, and subjective symptoms of dry mouth in subjects with chronic dry mouth symptoms. Thirteen subjects with chronic dry mouth symptoms and with a paraffin-stimulated salivary flow rate < or = 1 mL/min participated in the double-blind crossover study. Ten subjects had a very low salivary flow rate (< or = 0.6 mL/min). The subjects used both experimental toothpastes (with or without 4% betaine) twice a day for 2 weeks. Oral examinations and microbiologic sample collections were made at the base lines preceding the two experimental periods and at the end. Standardized questions on subjective symptoms of dry mouth were used when the subjects were interviewed at the end of the two experimental periods. No study-induced significant changes were observed in the microbiologic variables (plaque index, mutans streptococci, lactobacilli, Candida species) or in the appearance of the oral mucosa. The use of the betaine-containing toothpaste was, however, associated with a significant relief of several subjective symptoms of dry mouth. Betaine appears thus to be a promising ingredient of toothpastes in general and especially of toothpastes designed for patients with dry mouth.

Adult↗

The effects of 0.5% chlorhexidine and 0.2% triclosan containing toothpastes on salivary bacterial counts.

A number of antimicrobial compounds could be incorporated into toothpastes to enhance plaque inhibitory effects. However, the number of possible formulations is immense and makes clinical testing in plaque and gingivitis studies difficult. In this study, the effects on salivary bacterial counts of a number of chlorhexidine and triclosan toothpastes was evaluated as a predictor of persistence of antimicrobial action in the mouth. The study was a supervised, randomised 15-way crossover study employing 10 healthy human volunteers. All toothpastes were brushed for 1 min and comparison made with a 0.2% chlorhexidine rinse. The latter produced a large drop in salivary bacterial counts to the end of the 7-h study period. The toothpastes decreased salivary bacterial counts and all but two had notably more effect than a water brushing. No toothpaste showed a significant persistence of antimicrobial effect beyond 5 h. In the light of available plaque inhibition data for the toothpastes, persistence of antimicrobial activity beyond 5 h will be necessary for a clinical effect on plaque and gingival health. The method appears to be a simple and rapid screening technique for products formulated to enhance plaque inhibition mediated through an antimicrobial action.

Adult↗

Dentine hypersensitivity and the placebo response. A comparison of the effect of strontium acetate, potassium nitrate and fluoride toothpastes.

A considerable number of varied agents are apparently effective in the treatment of dentine hypersensitivity. In particular, the literature supports the efficacy of strontium, potassium and fluoride containing toothpastes. This study was a double-blind, randomised, parallel group comparison of three products, namely strontium- and potassium-based desensitising toothpastes both containing fluoride, and a conventional fluoride toothpaste. A total of 131 subjects entered a 4-week wash-in phase using the conventional fluoride toothpaste, of whom 120 entered a 6-week treatment phase. Sensitive teeth were evaluated at wash-in baseline, treatment baseline and after 2 and 6 weeks use of the treatment pastes. Dentine hypersensitivity was assessed with tactile and cold air stimuli together with an overall subjective assessment. Analysis of the findings was performed using non-parametric statistical methods. Of the original 120 subjects, 112 completed the trial. All 3 toothpaste groups showed reductions in sensitivity over the 6 weeks; however, no significant differences were found between the three products at any given time. Interestingly, there was no significant change in sensitivity between wash-in baseline and treatment baseline for the cold air stimulus with the fluoride-only-based paste. However, for the group using the same fluoride toothpaste, there was significant improvement between wash-in baseline and week 6, and treatment baseline and week 6 for this stimulus, suggesting a substantial placebo effect occurred. There is a need for further investigation of a wash-in period and examination of the placebo effect when evaluating dentine hypersensitivity trials.

Acetates↗

The effect of a new toothpaste containing potassium nitrate and triclosan on gingival health, plaque formation and dentine hypersensitivity.

OBJECTIVES: The purpose of this study was to investigate the effect of a new toothpaste containing an antiplaque and antiinflammatory agent (0.3% triclosan), a desensitizing agent (5% potassium nitrate) and an anticaries agent (0.76% sodium monofluorophosphate (SMFP)) on gingival health, plaque formation and dentine hypersensitivity in a 12-week home study. The efficacy of the test toothpaste was compared with that of a control toothpaste containing 5% potassium nitrate and 0.76% SMFP and a benchmark product containing only 0.76% SMFP. MATERIAL AND METHODS: One hundred and two healthy volunteers, who had a minimum of 20 natural permanent teeth with no probing depth >4 mm and at least one sensitive tooth, participated in this study. Following enrollment, the subjects received a dental prophylaxis and instruction in brushing technique. After a 4-week pre-experimental phase, baseline gingival bleeding index (GBI), plaque index (PI) and visual analogue scales (VASs) indicating dentine hypersensitivity levels responding to tactile and air stimuli were assessed. The subjects were then randomly given one of the three toothpastes; test, control, or benchmark toothpaste, and a soft-filamented toothbrush for home use. The GBI, PI and VASs were re-examined at weeks 4 and 12. RESULTS: Overall, the GBI scores were significantly reduced compared with baseline in all groups (p<0.01). However, there was no significant difference in GBI score among the three comparison groups. The PI score decreased in the test group and benchmark group from baseline to the end of study, whereas there was no significant change in the control group. Post hoc comparison indicated that the PI score was not statistically different between the three groups. There was a significant difference between the three treatment groups for sensitivity. For both the tactile and air stimuli, the reductions in VAS sensitivity scores for the test group and the control group were significantly greater compared with the benchmark group. Although the sensitivity score for air stimulus decreased more rapidly from baseline to week 4 in the test group, there was no overall difference between the test group and the control group. CONCLUSIONS: This study demonstrated that the new toothpaste was effective in reducing dentine hypersensitivity. More studies are needed to further determine the potential interaction between triclosan and potassium nitrate in dentifrices.

Adult↗

Using the DMF gender difference to assess the "major" role of fluoride toothpastes in the caries decline in industrialized countries: a meta-analysis.

The regular use of fluoridated toothpastes has been ascribed a major role in the observed decline in caries prevalence in industrialized countries during the last 20 to 25 years, but only indirect evidence supports this claim. The purpose of this study was to test the hypothesis that the more frequent use of fluoride toothpastes by girls than by boys has reduced the relative age-specific D(M)FT gender difference, and that this difference should decrease with increasing age and fluoride toothpaste exposure among adolescents. The material comprised 8,777 subjects 12 to 17 years of age from the pre-fluoride toothpaste era (1946-1959) and 39,903 from the period when use of fluoride toothpaste had become common (1983-1993) in industrialized countries. Meta-analyses were done using the relative age-specific mean D(M)FT difference between girls and boys. Separate analyses were carried out for subgroups of studies/countries to check for confounding. Regardless of analytical approach, no evidence was found to support the hypothesis. It is concluded that the gender difference in fluoride exposure due to tooth brushing frequency is too small to matter, that the study lacked power, or that the role of fluoride toothpastes in the caries decline has been overrated.

Adolescent↗

Development of a standardized method for comparing fluoride ingested from toothpaste by 1.5-3.5-year-old children in seven European countries. Part 2: Ingestion results.

OBJECTIVES: To develop a standardized method for measuring the variables affecting fluoride ingestion from toothpaste in young children between the ages of 1.5 and 3.5 years, and to use the method at seven European sites. METHODS: Random samples of children were invited to take part in the study. Parents who gave consent were visited at home. The children brushed their teeth using the toothpaste brand and toothbrush type currently in use. The difference between the fluoride dispensed onto the toothbrush and the fluoride recovered after accounting for losses was deemed to be the fluoride ingested. Details of other oral health-care habits were collected by questionnaire. For each child, the fluoride concentration of the toothpaste used was measured in the laboratory, from which an estimate of total daily fluoride ingestion was made. RESULTS: There was considerable variation between countries in the types of toothpaste used and in the amounts of toothpaste applied and ingested. The amount of fluoride ingested ranged from 0.01 to 0.04 mg fluoride per kg of body weight per day. CONCLUSION: The amount of fluoride ingested that is likely to be a risk factor for the development of dental fluorosis during tooth formation is equivocal and was found to vary widely between European countries. There appears to be a need for clearer health messages regarding the use of fluoridated toothpaste by young children.

Analysis of Variance↗

Effect of amine fluoride/stannous fluoride toothpaste and mouthrinse on dental plaque accumulation and gingival health.

OBJECTIVE: The aim was to investigate the influence of amine fluoride (AmF)/stannous fluoride (SnF2) containing toothpaste and mouthrinse on plaque accumulation and gingival health of young adults after 4 weeks use. SUBJECT AND METHODS: Forty-two young adults (mean age: 28.33 +/- 7.19 years) were examined for the Plaque Index (PI; Silness and Löe, 1964) and Gingival Index (GI; Löe and Silness, 1963) scores, and divided randomly into two groups. Both groups used AmF/SnF2 containing toothpaste twice a day for 3 min toothbrushing, and one group after toothbrushing rinsed with AmF/SnF2 containing mouthrinse for 30 s. After 4 weeks the probands were re-examined. RESULTS: Statistically significant decrease in dental plaque (PI) and gingival (GI) index values were found at the end of the study. The reduction of PI and GI values was significant in all groups but it was higher in the combined (toothpaste + mouthrinsing) group, than using toothpaste only. CONCLUSION: The regular combined use of AmF/SnF2 toothpaste and mouthrinse was more effective in the reduction of plaque accumulation and maintenance of gingival health than the toothpaste alone.

Adult↗

Clinical studies to determine the effectiveness of a whitening toothpaste at reducing stain (using a forced stain model).

AIMS: Two single centre, randomized single-blind, crossover studies were performed, to compare the effect of a test toothpaste with a conventional fluoride paste in the inhibition and removal of extrinsic dental stain promoted by repeated chlorhexidine/tea rinses. METHODS: These studies used 24 subjects in each of two separate clinical trials. On the Friday before each trial period, the subjects received a prophylaxis to remove all staining, plaque and calculus deposits. On the following Monday, subjects were checked whether they were stain free and then under direct supervision they rinsed with a 0.2% chlorhexidine mouthrinse, immediately followed by a rinse with a warm black tea solution. This cycle was repeated hourly eight times throughout the day and on the following days until the Friday. In addition subjects also received daily a single toothpaste slurry rinse or control water rinse in the morning and lunchtime. No other form of oral hygiene was permitted during this period. On the Friday, both stain area and intensity was assessed using the Lobene Stain Index. For the stain removal study, stain was promoted again using chlorhexidine and tea rinses. After 4 days, stain was measured both prior to and immediately after brushing with the allocated toothpaste for 2 min. Subjects were then instructed to use the toothbrush at home according to their normal oral hygiene practices. On the following Wednesday, the amount of stain present was re-assessed. Each subject subsequently received a thorough prophylaxis to remove all plaque calculus and staining before starting the following periods of the study. RESULTS: The study showed no difference in the ability of the test whitening toothpaste, control toothpaste and water control at inhibiting stain. There was also only a small difference (3.5% for product of area and intensity) between the ability of the two toothpastes to help remove stain after a single brushing. The difference was however in favour of the test product which approached a conventional level of significance (P = 0.089). There was no evidence of superiority for either of the pastes after normal home usage. CONCLUSIONS: This study has suggested that the test product may have some advantage over the conventional paste at removing stain but the magnitude of difference would appear to be small and of little clinical relevance.

Adult↗

The anti-caries efficacy of calcium carbonate-based fluoride toothpastes.

AIM: To summarise clinical support for the anti-caries efficacy of fluoride toothpastes containing sodium monofluorophosphate (SMFP) and to discuss the possible means by which the abrasive particles in calcium carbonate-based SMFP toothpastes might complement and/or enhance fluoride efficacy. BACKGROUND: The anti-caries efficacy of fluoride has been proven beyond any reasonable doubt, and the efficacy of SMFP, when incorporated into a variety of compatible toothpaste formulations, has been established in numerous clinical trials. Calcium carbonate-based toothpastes may also influence caries by effecting an increase in plaque calcium levels; an inverse relationship between plaque calcium and caries is well-established. It has also been reported that plaque fluoride levels are dependent on plaque calcium levels. Hence elevated plaque calcium resulting from the use of calcium carbonate-based toothpastes has the potential to elevate plaque fluoride, itself linked to reduced caries experience. It has been shown that calcium carbonate particles are retained by plaque and this may also influence caries by neutralising harmful plaque acids and concurrently liberating calcium. CONCLUSION: Fluoride delivered from calcium carbonate-based SMFP toothpastes is an effective means of reducing caries. Further, calcium carbonate may confer additional benefits through elevation of oral calcium levels and neutralisation of plaque-acids.

Calcium Carbonate↗

Efficacy of fluoride toothpaste in preventing demineralization of smooth dentin surfaces and narrow grooves in situ under frequent exposures to sucrose or bananas.

The use of models simulating fissures allows studying demineralization at sites that are most prone to caries in vivo. In practice, most in situ models use flat surfaces. Our objectives were: (1) to compare the demineralizing potential of sucrose solution with that of bananas and (2) to study the effect of fluoride toothpaste on demineralization in situ in an easily accessible site and a plaque stagnation site. Four volunteers wore bovine dentin specimens with narrow grooves and a smooth surface for two 1-week in situ periods, with eight 1-min sugar exposures daily: either by a rinse with 10% sucrose, or by consumption of a piece of banana. Twice daily, the appliance was dipped in toothpaste slurry of a control (fluoride-free) toothpaste at one side and a fluoride toothpaste at the contralateral side. Demineralization was assessed by transversal microradiography. We found no difference in dentin demineralization after frequent exposure to either sucrose solution or bananas. Fluoride toothpaste effectively protected dentin only at the smooth surface. In the grooves, fluoride affected the demineralization pattern; it drove lesions towards the bottom of the groove. We conclude that assessing only smooth surfaces in intraoral tests might lead to underestimated food cariogenicity and to overestimated efficacy of fluoride-containing toothpaste.

Adult↗

Effect of withdrawal of fluoride-containing toothpaste on the interproximal plaque microflora.

To compare the effects of fluoride-containing and fluoride-free toothpaste on plaque microflora, 15 subjects were enrolled in a double-blind crossover trial. All subjects used a fluoride toothpaste for 7 days before the trial started. Then, 4 interproximal sites per subject were professionally cleaned and subjects used one of the toothpastes for 5 days. On the 5th day plaque was collected from 2 sites, 12 and 6 h after toothpaste use. There was no difference between the groups in the numbers or proportions of aciduric bacteria (recovered at pH 4.8 or 5.2), or of yeasts, neisseriae, lactobacilli or streptococci (total or individual species, including Streptococcus mutans). However, the numbers and proportions of Gram-positive pleomorphic rods, primarily Actinomyces naeslundii, increased in 6-hour samples from subjects using fluoride toothpaste. The data suggest that the anti-caries effect of fluoride toothpaste is not mediated primarily through effects on the plaque microflora, although effects on plaque physiology could be important.

Adult↗

Fluoride, calcium and inorganic phosphorus concentrations in approximal plaque collected from young adults 1 and 24 h after toothbrushing with fluoride toothpastes.

A within-subject double-blind cross-over study was carried out to examine whether the chemical composition of approximal plaque was altered 1 and 24 h after brushing with fluoride toothpaste. Three fluoride toothpastes were tested, containing either sodium monofluorophosphate with calcium glycerophosphate supplement and calcium carbonate abrasive, a combination of sodium monofluorophosphate and sodium fluoride with the same supplement and abrasive or sodium fluoride with a silica abrasive. A fluoride-free toothpaste with a silica abrasive acted as the control. 19 subjects used the toothpastes separately in randomised order for 1 week each prior to collection of plaque. Contralateral half-mouth approximal plaque samples were collected 1 and 24 h after the last use of each toothpaste. Fluoride, calcium and inorganic phosphorus concentrations of plaque were estimated. The results indicated that brushing with toothpastes containing fluoride and/or calcium supplements resulted in increased concentrations of these constituents in approximal plaque 1 h after brushing. These elevated levels of inorganic ions were not observed in the samples collected 24 h after brushing. It was concluded that the potentially beneficial effect of a raised concentration of fluoride and calcium in approximal plaque observed soon after brushing is lost during the following 24 h.

Adult↗

Effects of a lactoperoxidase system-containing toothpaste on levels of hypothiocyanite and bacteria in saliva.

Lactoperoxidase (LPO)/H2O2/SCN(-)-system-generated hypothiocyanite ions (OSCN-) and hypothiocyanous acid (HOSCN) are inhibitory against a number of oral bacteria, including mutans streptococci. A commercially available toothpaste (Biotene) comprises the complete LPO system. Generation of HOSCN/OSCN- by Biotene was studied in vitro both in sterilized and nonsterilized saliva of 10 healthy subjects. The HOSCN/OSCN- yield ranged from 100 to 300 microM with Biotene, while the salivary levels of HOSCN/OSCN- before the addition of Biotene were 30.1 +/- 25.1 microM. Two in vivo trials were carried out. In the first study, resting saliva was collected from 12 individuals before, immediately after, and 2, 5, 10 and 20 min after brushing with Biotene to evaluate the in vivo generation and decomposition of HOSCN/OSCN-. In the second study, 26 healthy individuals attended a 1-month crossover trial with Biotene and a control toothpaste, Vademecum (no LPO system), both containing F- and xylitol. The salivary counts of total streptococci, mutans streptococci (MS), lactobacilli and the total flora (TF), as well as the peroxidase, thiocyanate ion and HOSCN/OSCN- levels were determined before and after 2 and 4 weeks daily use of the toothpastes. Twice-a-day use of Biotene for 1 month resulted in an elevation of 'resting levels' of HOSCN/OSCN-. No such effect was found with the control toothpaste. No significant changes were found in the salivary levels of total streptococci, MS, lactobacilli or TF after 1-month use of either toothpaste. The results show the capability of the LPO-system-containing toothpaste to elevate the salivary levels of HOSCN/OSCN-, although no bactericidal effect was observed.

Colony Count, Microbial↗

Enamel demineralization in situ with various frequencies of carbohydrate consumption with and without fluoride toothpaste.

There is little information in the literature on the relationship among the frequency of carbohydrate consumption, the use of fluoride toothpaste, and enamel demineralization. The aim of this investigation was to compare the extent of demineralization of enamel slabs in situ, with a sugar-based solution, consumed in constant amounts but with various frequencies in subjects both with and without the use of fluoride (F) toothpaste. Eight subjects wore removable mandibular appliances carrying an enamel slab cut from white-spot lesions. The subjects were required to drink 500 mL of a 120-gm/L sugar solution either once, 3, 5, 7, or 10 times/day for 30 sec on each occasion, for a period of 5 days while brushing their teeth twice daily with either a F (1450 ppm NaF) or a F-free toothpaste. Mineral analysis revealed that when the subjects used a F toothpaste, net demineralization was evident only with the seven- and 10-times/day regime (ns). When F-free toothpaste was used, statistically significant demineralization was observed when the frequency exceeded 3 times/day. This study demonstrates the importance of F-containing toothpaste in enamel re-/demineralization by varying the frequency of carbohydrate challenge

Adult↗

The effect of a fluoridated toothpaste on dentinal lesions in plaque-filled grooves: an intra-oral crossover study.

Recently, we introduced an intra-oral dentin demineralization model to evaluate the efficacy of a fluoridated toothpaste at plaque-retention sites with limited access to salivary components and fluoride. Usage of the fluoridated toothpaste reduced mineral loss from grooves in sound dentin by 15% compared with a non-fluoridated toothpaste (Lagerweij et al., 1997). In the current study, preformed dentinal lesions were subjected to similar toothpaste treatments. To improve the power of the model in discriminating between toothpaste groups, we changed the design from monadic to crossover to reduce the influence of variation between the participants. Two sets of specimens were placed in the partial prostheses of 29 participants who used a toothpaste containing either 1000 ppm fluoride or no fluoride during two consecutive six-week periods. Changes in mineral content were analyzed by transverse microradiography. The average mineral loss after the non-fluoride period was 1785 vol% x micron (SD 2399), and 1335 vol% x micron (SD 2039) after the fluoride period, a 25% inhibition in demineralization. Analysis of variance showed that the demineralization was significantly influenced not only by the type of treatment (p < 0.001 level), but also by the participant (p < 0.001), the width of the groove (p < 0.001), and the depth into the groove where changes in mineral content were measured (p < 0.017). Twenty-one percent of all the lesions showed remineralization. No significant difference in the extent or the occurrence of remineralization was found between the treatments.

Adult↗

Cleaning power and abrasivity of European toothpastes.

For 41 toothpastes available to European consumers in 1995, the cleaning efficacy was evaluated in comparison with abrasivity on dentin (RDA value). For cleaning power assessment, a modified pellicle cleaning ratio (PCR) measurement method was developed. The method is characterized by a five-day tea-staining procedure on bovine front teeth slabs on a rotating wheel, standardized brushing of the slabs in a V8 cross-brushing machine, and brightness measurement by a chromametric technique. All tested products were in accordance with the new DIN/ISO standard 11,609 for toothpastes in terms of dentin abrasivity. Not a single product exceeded an RDA value of 200. The majority of toothpastes (80%) had an RDA value below 100. Only three products surpassed the reference in cleaning power. Most products (73%) had a cleaning power (PCR value) between 20 and 80. The correlation between cleaning power and dentin abrasion was low (r = 0.66), which can be explained with the different influence on dentin and stains by factors like abrasive type, particle surface and size, as well as the chemical influence of other toothpaste ingredients. Some major trends could be shown on the basis of abrasive types. The ratio PCR to RDA was rather good in most silica-based toothpastes. A lower ratio was found in some products containing calcium carbonate or aluminum trihydrate as the only abrasive. The addition of other abrasives, such as polishing alumina, showed improved cleaning power. Some active ingredients, especially sequenstrants such as sodium tripolyphosphate or AHBP, also improve the PCR/RDA ratio by stain-dissolving action without being abrasive. The data for some special anti-stain products did not differ significantly from standard products. Compared with data measured in 1988, a general trend toward reduced abrasivity without loss of cleaning efficacy could be noticed on the European toothpaste market. This may be mostly due to the increased use of high-performance abrasives such as hydrated silica.

Animals↗

A randomised controlled trial of the effectiveness of providing free fluoride toothpaste from the age of 12 months on reducing caries in 5-6 year old children.

OBJECTIVE: To assess the impact of regularly supplying free fluoride toothpaste regularly to children, initially aged 12 months, and living in deprived areas of the north west of England on the level of caries in the deciduous dentition at 5-6 years of age. A further aim was to compare the effectiveness of a programme using a toothpaste containing 440 ppmF (Colgate 0-6 Gel) with one containing 1,450 ppmF (Colgate Great Regular Flavour) in reducing caries. DESIGN: Randomised controlled parallel group clinical trial. Clinical data were collected from test and control groups when the children were 5-6 years old. SETTING: A programme of posting toothpaste with dental health messages to the homes of children initially aged 12 months. Clinical examinations took place in primary schools. PARTICIPANTS: 7,422 children born in 3-month birth cohorts living in high caries areas in nine health districts in north west England. Within each district children were randomly assigned to test or control groups. INTERVENTIONS: Toothpaste, containing either 440 ppmF or 1450 ppmF, and dental health literature posted at three monthly intervals to children in test groups until they were aged 5-6 years. MAIN OUTCOME MEASURES: The dmft index, missing teeth and the prevalence of caries experience. RESULTS: An analysis of 3,731 children who were examined and remained in the programme showed the mean dmft to be 2.15 for the group who had received 1,450 ppmF toothpaste and 2.49 for the 440 ppmF group. The mean dmft for the control group was 2.57. This 16% reduction between the 1,450 ppmF and control group was statistically significant (P<0.05). The difference between the 440 ppmF group and control was not significant. Further analyses to estimate the population effect of the programme also confirmed this relationship. CONCLUSION: This study demonstrates that a programme distributing free toothpaste containing 1,450 ppmF provides a significant clinical benefit for high caries risk children living in deprived, non-fluoridated districts.

Analysis of Variance↗