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. A supervised brushing trial of sodium monofluorophosphate dentifrices in a fluoridated area. A 3-year clinical trial of the effect on dental caries of a dentifrice containing 2% sodium monoflurophosphate. The effects of changing caries prevalence and diagnostic criteria on clinical caries trials. Relative efficacy of dentifrices containing 250 or 1000 ppm F- in preventing dental caries--report of a 32-month clinical trial. Caries-preventive effect of fluoride dentifrices with and without anticalculus agents: a 3-year controlled clinical trial. Caries-inhibition by an amine fluoride dentifrice results after 6 years in children with low caries activity. A dentifrice containing 0.8 per cent sodium monofluorophosphatein an aluminium oxide trihydrate base. A 3-year clinical trial. A PRELIMINARY COMPARISON OF A DENTIFRICE CONTAINING FLUORIDE AND SOLUBLE PHOSPHATE AND EMPLOYING A CALCIUM-FREE ABRASIVE WITH OTHER TYPES OF FLUORIDE DENTIFRICES. FIRST YEAR REPORT OF A CLINICAL STUDY. Comparative unsupervised clinical trial on caries inhibition effect of monofluorophosphate and amine fluoride dentifrices after 3 years in Strasbourg, France. A multiple-examiner clinical evaluation of a sodium fluoride dentifrice. [Clinical experimentation with a fluoridated dentifrice]. A clinical trial of a calcium carbonate base dentifrice containing 0.76% sodium monofluorophosphate. A three-year clinical trial of a combination of trimetaphosphate and sodium fluoride in silica toothpastes. Caries prevention by dentifrices containing a combination of sodium monofluorophosphate and sodium fluoride. Report of a 3-year clinical trial. Caries prevention using a 1.2% sodium monofluorophosphate dentifrice in an aluminium oxide trihydrate base. Caries prevention by daily supervised use of a MFP gel dentifrice. Report of a 3-year clinical trial. A 3-year clinical trial to compare efficacy of dentifrices containing 1.14% and 0.76% sodium monofluorophosphate. Effect of stannous fluoride treatments on the progression of initial lesions in approximal surfaces of permanent posterior teeth. A 3-year clinical trial of calcium carbonate dentifrice containing calcium glycerophosphate and sodium monofluorophosphate. Studies on the effect of dentifrices with low fluoride content. An abbreviated caries clinical trial design validated over 24 months. A three-year clinical comparison of a sodium monofluorophosphate dentifrice with sodium fluoride dentifrices on dental caries in children. The relative anticaries effectiveness of three fluoride-containing dentifrices in Puerto Rico. Caries inhibition of a dentifrice containing 0.78% sodium monofluorophosphate in a silica base. EVALUATION OF A STANNOUS FLUORIDE-CALCIUM PYROPHOSPHATE DENTIFRICE. A clinical evaluation of a stannous fluoride and a sarcosinate dentifrice. Clinical evaluation of an aged stannous fluoride-calcium pyrophosphate dentifrice. Clinical testing of a mouthrinse and a dentifrice containing fluoride. A two-year supervised study in school children. Some statistical aspects of a clinical study on dental caries in children. Low-fluoride dentifrice and caries lesion control in children with different caries experience: a randomized clinical trial. A 3-year oral health dose-response study of sodium monofluorophosphate dentifrices with and without zinc citrate: anti-caries results. The effect of a fluoride gel used for supervised toothbrushing 15 or 30 times per year. Clinical evaluation of neutral sodium fluoride, stannous fluoride, sodium monofluorophosphate and acidulated fluoride-phosphate denifrices. [Cariostatic effect of Fluocaril; controlled clinical research]. [Caries prevention by means of a Na2FPO3-toothpaste after 7 year's application]. A four-year clinical study to determine the caries-inhibiting effect of calcium glycerophosphate and sodium fluoride in calcium carbonate base dentifrices containing sodium monofluorophosphate. A clinical comparison of fluoride and antienzyme dentifrices. Relative anti-caries efficacy of 1100, 1700, 2200, and 2800 ppm fluoride ion in a sodium fluoride dentifrice over 1 year. Cariostatic effect of a stannous fluoride-containing dentifrice on children: two-year report of a supervised toothbrushing study. The relative caries-inhibiting effects of a stannous fluoride dentifrice in a silica gel base. Clinical comparison of the caries inhibition of two mixed NaF-Na2PO3F dentifrices containing 1,000 and 2,500 ppm F compared to a conventional Na2PO3F dentifrice containing 1,000 ppm F: results after two years. Clinical evaluation of three concentrations of sodium fluoride in dentifrices. Caries-inhibiting effect of a stannous fluoride silica gel dentifrice: a three-year clinical study. A comparison between the anticariogenic effects of dentifrices containing stannous fluoride and sodium fluoride. Effect of SnF2 dentrifices on caries in children: two-year clinical study of supervised brushing in children's homes. [Controlled clinical study of the caries prophylactic activity of a new bifluoride toothpaste (sodium monofluorophosphate + sodium fluoride)]. A clinical evaluation of a sodium fluoride dentifrice. Results from a three-year caries clinical trial comparing NaF and SMFP fluoride formulations. Clinical testing of fluoride and non-fluoride containing dentifrices inHounslow school children. Clinical trial of a low-fluoride toothpaste for young children. Combined effects of a fluoride dentifrice and mouthrinse on the incidence of dental caries. Clinical investigation of the anticaries efficacy of a 1.14% sodium monofluorophosphate (SMFP) calcium carbonate-based dentifrice: a two-year caries clinical trial on children in China. Stannous fluoride and sodium monofluorophosphate dentifrices. Clinical testing in London school children--radiological findings. Results of gingival, plaque, and stain assessments after 30 months use of amine fluorides and their inorganic counterparts. [3-year clinical tooth cream test with toothpastes of varying fluoride content: 0.8% and 1.2% sodium monofluorophosphate]. Reversal of incipient and radiographic caries through the use of sodium and stannous fluoride dentifrices in a clinical trial. A clinical investigation of a high-level fluoride dentifrice. A three-year clinical study to determine the separate and combined caries-inhibiting effects of sodium monofluorophosphate toothpaste and an acidulated phosphate-fluoride gel. Effect of supervised use of an alum mouthrinse on dental caries incidence in caries-susceptible children: a pilot study. The effect of NaF and SMFP toothpastes on three-year caries increments in adolescents.
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.
                Randomised controlled parallel group clinical trial. Clinical data were collected from test and control groups when the children were 5-6 years old.
                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.
                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.
                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.
                The dmft index, missing teeth and the prevalence of caries experience.
                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.
                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. nan A clinical trial of a dentifrice containing 2% sodium monofluorophosphate was carried out on 782 schoolchildren in Shropshire, England. After 3 years, a reduction of 23.8% was found in the DMFS increment obtained from clinical examination. The reduction was 38.8% using radiographs. The children were divided into three groups according to baseline DMFS. Those with a "medium" caries experience were found to benefit most from using the dentifrice. There was a difference in the effect on individual tooth sites; the approximal surfaces of the posterior teeth received the most benefit and the occlusal surfaces the least. nan nan A 3-year, double-blind, randomized caries trial was conducted to evaluate the relative anticaries efficacy of four sodium fluoride dentifrices containing 250 ppm fluoride, 1,000 ppm fluoride in combination with 1% disodium 1-hydroxyethylidene-1.1-bisphosphonate (HEBP), and 1,000 ppm fluoride in combination with 1% disodium azacycloheptylidene-2.2-bisphosphonate (AHBP). As a positive control, a monofluorophosphate dentifrice (1,000 ppm fluoride) was used. At outset 1,161 Icelandic children, 11 and 12 years of age, were randomly assigned to one of the five treatment groups and 1,035 subjects completed the trial. After 3 years of unsupervised brushing, the dentifrice containing 250 ppm fluoride was significantly less effective in controlling the caries increment. The combination of sodium fluoride and AHBP was significantly more effective than the positive control. nan nan nan A randomized, double blind clinical trial of the caries inhibition effects of dentifrices containing respectively monofluorophosphate and amine fluoride was performed. A third control group used a toothpaste without fluoride. A total number of 2008 schoolchildren ranging in age from 6 to 8 years and living in Strasbourg (France) participated in this study. After a baseline examination three groups were constructed with the block randomization technic. The caries inhibition effects of the three dental pastes were compared after 3 years of unsupervised use. The monofluorophosphate dentifrice showed a reduction of 7.02% for DMFT, 5.17% for DMFS and 25.26% for the df rate. The reduction of amine fluoride dentifrice caries was respectively 21.62% for DMFT, 20.94% for DMFS and 48.66% for the df rate. nan nan nan The relative efficacy of NaF silica toothpastes containing 1000 ppm fluoride and 1500 ppm fluoride in the control of dental caries is not clear-cut. Also, it has not been established that incorporation of trimetaphosphate (TMP) improves the anticaries activity of NaF toothpastes. A three-year clinical trial was conducted to test the hypotheses that: (i) the anticaries activity of NaF toothpastes containing 1500 ppm F was greater than that of NaF toothpastes containing 1000 ppm F, and (ii) inclusion of TMP improved the efficacy of NaF silica pastes. Subsidiary aims included determination of whether frequency of toothbrushing and method of rinsing after brushing were correlated with caries increments. The study involved 4196 children aged 11 to 12 years at outset. These participants had been selected from a pool of 7374 potential subjects on the basis of caries experience and dental eruption pattern. They were stratified by sex, examiner, and presence of calculus and caries, and were allocated at random to one of the four toothpastes under study. Using mirror and probe and also FOTI, we carried out clinical examinations at baseline and annually thereafter for 3 yrs. Bitewing radiographs of a subset of children were taken at baseline and at the end of the study. The outcome measure for the study, DMFS increment, was defined as the increase in caries over 3 yrs, taking into account changes occurring on individual tooth surfaces. Data for 3467 subjects were available for analyses at both baseline and year 3 examinations. Radiographs were taken for 1942 subjects at both baseline and year 3 examinations. The mean three-year clinical-only DMFS increment for the subjects using 1500-ppm-NaF pastes was 3.93, which was 6% lower than the corresponding mean of 4.19 for the 1000-ppm-NaF pastes. There was no significant difference between the mean DMFS increment for those using paste with or without TMP. Subjects who claimed to brush more frequently or who claimed not to use a tumbler to rinse after toothbrushing had lower three-year DFMS increments. nan A 3-year clinical trial was carried out in France just after fluoride toothpaste was allowed to be sold on the mass market. The aim was to assess the caries preventive effect of a toothpaste containing the maximum fluoride level permitted by the EEC (1.2% SMFP). The trial started with 1318 10-12-yr-old children from a wide socioeconomic background in a typical French community. Test toothpaste was given to 659 children whereas the remaining 659 children obtained the same toothpaste without the fluoride additive. The brushing was unsupervised and performed by the children at home. Dental caries was assessed by clinical and radiographic examinations. 1061 children completed the trial. An interview carried out at the final examination identified a group of 116 uncooperative children (less than five brushings a week on average) who were not included in the statistical analysis. The following mean reductions were found: 26% for DMFT, 27% for DMFS, and 39% for DMFSU. The DMFS index for approximal, buccal-lingual and occlusal surfaces showed caries reductions of 32%, 25%, and 22%, respectively. The trial demonstrated a highly significant effectiveness of the 1.2% SMFP toothpaste in a French population. nan A 3-yr daily supervised toothbrushing study with a double blind design was conducted to evaluate the anticaries effectiveness of a 1.14% sodium monofluorophosphate (MFP) dentifrice (1500 ppm F) compared to a 0.76% MFP dentifrice (1000 ppm F). This study began with nearly 4000 children, primarily aged 8-11, in grades 3-5, residing in a nonfluoridated community in Florida. A total of 2415 children completed 3 yr of the study, representing 61% of the children who began the study. The results indicate a statistically significant (P less than 0.001) anticaries benefit was derived over a 3-yr period from the use of the higher fluoride dentifrice (1500 ppm F) when compared to the positive control (1000 ppm F). Percent reductions in mean dental caries increments were 20.9%, 22.1%, 21.8%, 24.3%, and 35.2% for DMFT, DFT, DMFS, DFS, and DFS Interproximal, respectively. Bite-wing radiographs were used to determine the effect of three forms of topical SnF2 therapy on the progression of initial lesions in the approximal surfaces of permanent posterior teeth. Radiographs were taken annually over a four-year period. The subjects were schoolchildren, aged 12-14 yr, living in a low fluoride area. The professional application of a 10% SnF2 solution for 30 s, semi-annually for two yr, had no discernible effect on the development of the initial lesions. However, the home use of a SnF2 dentifrice did inhibit caries progression appreciably at all but one of the four time intervals in the study. The professional application of a 10% SnF2 solution for 30 s, semi-annually for two yr, combined with the home use of a SnF2 dentifrice, was the most effective treatment in retarding lesion development. Even without topical fluoride therapy, the rate of progression of initial approximal lesions was generally quite slow. In view of these findings, it would seem sound clinical practice to treat all initial lesions in approximal surfaces with topical fluoride therapy and delay placement of restorations until there is radiographic evidence of lesions reaching dentin. nan nan Conventional caries trials last from 24 to 36 months. This study evaluated whether the previously established difference in efficacy between 1000- and 2500-ppm-fluoride dentifrices could be detected after 12 months. Caries was assessed by clinical visual assessment (CVA-simplified version of Dundee Selectable Threshold Method - DSTM), bitewing radiography, and Fiber Optic Transillumination (FOTI). Changes in status for individual surfaces were classified by means of pre-prepared matrices as 0 (unchanged), +1 (initiation or progression), or -1 (regression) and summed for each subject to yield an event score. Mean group event scores were calculated for each product. DSTM at the D(1) [enamel and dentin] threshold showed significant inter-group differences in mean event scores (p < 0.003) and D(1)MFS increment (< 0.007) at 12 months; these were confirmed at 24 months by traditional increment analysis (CVA & FOTI at the D(3) (dentin only) threshold + radiography, p < 0.03). This study confirms the validity of an abbreviated trial protocol. This study compared the anticaries effects of these three fluoride-containing dentifrices: 1100 ppm F as NaF (positive control); 2800 ppm F as SMFP; and 2800 ppm F as NaF. The group using the 2800 SMFP dentifrice showed no significant differences in DMFS or DMFT, compared to the positive control, at anytime during the study. This indicated that higher levels of sodium monofluorophosphate in a dentifrice offer no advantage in caries protection over the conventional level of sodium fluoride, 1100 ppm F. The objective of this research was to evaluate the anticaries effectiveness of a low-dose (500 ppm F, low-NaF) sodium fluoride dentifrice, a high-dose (2,800 ppm F, high-NaF) sodium fluoride dentifrice and an experimental 0.454% stabilized stannous fluoride (1,100 ppm F) with sodium hexametaphosphate (SnF2-HMP) dentifrice, each relative to a standard 1,100 ppm F sodium fluoride positive control dentifrice. Subjects (n = 955, with approximately 239 per group) with a mean age of 10.6 (approximately 9-12 years) were randomly assigned to one of four dentifrice treatments. Two calibrated examiners independently measured visual-tactile caries as DMFS that was supplemented with a radiographic examination at baseline, 12 months and 24 months for each subject. Generally similar results were independently observed by both examiners at the conclusion of the 2-year study period. Considering all subjects that attended at least 60% of the supervised brushing sessions, statistically significantly less caries was observed in the high-NaF group compared to the control group. Similarly, statistically significantly less caries was observed in the SnF2-HMP group as compared to the control group. Differences in caries increments between the low-NaF and control groups were not statistically significant. One of the examiners observed these same statistically significant differences after 1 year. In conclusion, the results of this clinical trial indicated that while no difference in caries increments was observed between the low-NaF and control groups, both the high-NaF and the SnF2-HMP groups experienced significantly fewer lesions than the control group.
                2004 S. Karger AG, Basel. The purpose of this double blind clinical trial was to determine the anticaries activity of a dentifrice containing 0.78% sodium monofluorophosphate in a silica gel abrasive base compared with a placebo under conditions of supervised brushing. 1154 schoolchildren, ages 9-12, were recruited in a non-fluoridated semi-rural area of northeastern Connecticut. Subjects were stratified according to school, grade and sex, and then randomly divided into two groups. Each school day, children brushed their teeth for 1 min under supervision by project personnel. Weekend and vacation usage was ad libitum. Caries examinations and radiographic readings were performed by the same examiner (J.R.). After 12 months, the 996 subjects examined showed that the group using the test dentifrice had significantly (less than 0.05) lower DMFT (25.0%) and DMFS (19.1%) increments than the group using the placebo. After 24 months the 876 subjects examined showed that the test group continued to have significantly lower DMFT (24.5%) and DMFS (24.7%) increments than the placebo group. Surface protection after 24 months ranged from 22.1% for occlusal to 37.1% for interproximal surfaces. nan nan nan nan nan Since there is no consensus on the anticaries effectiveness of low-fluoride (F) dentifrice, this randomized clinical trial evaluated its effect in children at different caries activity status. One hundred and twenty 2- to 4-year-old children, half with and half without active caries lesions, were randomly divided into 2 groups which used 500- or 1,100-microg F/g (NaF) dentifrices during 1 year. Caries progression or regression were evaluated as the number of lesions becoming active/cavities or inactive, respectively. The anticaries effect of the low-F dentifrice was similar to the conventional F dentifrice when used by caries-inactive children. However, in children with active caries lesions the low-F dentifrice was less effective than the 1,100-microg F/g dentifrice in controlling the progression of lesions. The data suggest that the child caries activity may be taken into account to recommend a low-F dentifrice. A 3-yr clinical trial has been conducted on 3000 12-yr-old children in Lanarkshire, Scotland, with the aim of investigating the effects on oral health of toothpastes containing both sodium monofluorophosphate and zinc citrate, the former being present at fluoride levels of 1000, 1500, and 2500 ppm F. No significant difference in caries increments was found between the group of children using toothpastes incorporating zinc citrate and their counterparts using zinc-free pastes. However, a significant anti-caries dose-response was demonstrated over the SMFP range used. This dose-response was evident for boys and girls and also for the various types of teeth and tooth surfaces. nan nan A controlled, double-blind trial on 42 children showed that a dentrifrice containing 0,25% fluorine clearly prevented caries when used continuously for 2 years. This effects was greater than that of a similar toothpaste containing fluorine. Tolerance was excellent. After 7 years unsupervised use of a Na2FPO3 paste the number of new DMF-surfaces was 36 to 38% lower than in the control group. The caries-inhibiting effect is statistically significant (P less than 0.001). Separate consideration of the first molar reduced caries of the other teeth to 40--42%. nan nan There is limited evidence from clinical trials on the dose response of sodium fluoride dentifrices at concentrations above 1100 ppm fluoride ion, with respect to caries efficacy. This randomized, double-blind study examined the anti-caries effectiveness of sodium fluoride dentifrices containing 1700 ppm, 2200 ppm and 2800 ppm fluoride ion relative to an 1100 ppm fluoride ion control. A population of 5439 elementary schoolchildren, aged 6-15 years, was recruited from an urban central Ohio area with a low fluoride content water supply (<0.3 ppm). Subjects were examined by visual-tactile and radiographic examination at baseline and after 1, 2, and 3 years of using the sodium fluoride dentifrices. Subjects were stratified according to gender, age and baseline DMFS scores derived from the visual-tactile baseline examination and randomly assigned to one of four treatment groups: 0.243% sodium fluoride (1100 ppm fluoride ion), 0.376% sodium fluoride (1700 ppm fluoride ion), 0.486% sodium fluoride (2200 ppm fluoride ion), and 0.619% sodium fluoride (2800 ppm fluoride ion). All products were formulated with the same fluoride compatible silica abrasive. Results after 1 year provided evidence of a positive sodium fluoride dose response. Compared to the 1100 ppm fluoride treatment group, the 1700 ppm fluoride treatment group had an 11.0% reduction in DMFS that was not statistically significant, while the 2200 ppm and 2800 ppm fluoride treatment groups showed statistically significant (P<0.05) reductions of 18.6% and 20.4%, respectively. The reductions in caries delivered by the higher fluoride dentifrices were present across all tooth surface types, but were most pronounced for occlusal surfaces. Results at years 2 and 3 were confounded by a concurrent fluoride rinse program, which involved portions of the study population. While the trends for the higher fluoride dentifrices observed at year 1 remained at years 2 and 3, the difference observed between treatments were substantially less and failed to reach statistical significance (P<0.05). Collectively, the data demonstrate that the 2200 ppm and the 2800 ppm fluoride treatments delivered statistically significantly greater caries efficacy than the 1100 ppm fluoride treatment. This large-scale clinical trial provides evidence of a positive statistically significant dose relationship between dental caries and sodium fluoride in a dentifrice at levels above 1100 ppm fluoride at year 1. nan An unsupervised toothbrushing study involving 1,339 children from 5 to 13 years of age conducted for three years compared two stannous fluoride dentifrices, one in a calcium pyrophosphate base and the other in a silica gel base, with a nonfluoride control dentifrice. The test dentifrice, stannous fluoride in a silica gel base, reduced caries to a significant extent when compared with the nonfluoride control dentifrice.The percentage of reductions ranged from 15% to 25% for whole mouth and interproximal surface indexes. There was no significant difference between the two fluoride dentifrices. nan nan nan nan nan nan A double-blind study to determine the anticaries efficacy of a neutral pH dentifrice containing sodium fluoride and a high Beta-phase calcium pyrophosphate was conducted among elementary school children in Kansas City, Missouri. A sample of 567 children ages 8-13 were recruited and randomly assigned to test and control groups: the test group received a sodium fluoride high Beta-phase calcium pyrophosphate dentifrice, and the control group received a calcium pyrophosphate dentifrice without the active ingredient. The sodium fluoride dentifrice contained fluoride at the level of 1000 ppm. Caried examinations were conducted at initiation, after 12 months, and again after 24 months at the study's termination. All examinations (clinical and radiographic) were performed by the same investigator. At 12 months the sodium fluoride dentifrice demonstrated a caries reduction of 24.1% (DMFS). At 24 months the reduction demonstrated was 30.1% (DMFS); this reduction is significant at alpha = 0.05. A three-year, double blind, randomised clinical trial was conducted in Polk County, Florida from 1983-1987. The objective was to compare the effect of four dose levels of sodium monofluorophosphate (SMFP) and a single dose level of sodium fluoride (NaF) on DMFS, DMFT, and DFS Interproximal indices. A total of 8,027 children were examined clinically and radiographically at baseline, and 5,474 children completed the three-year study, which included daily supervised brushing at school. No differences existed at baseline between the five study cells on age or gender distribution, or on any of the dental indices. Results indicated that the 2000 ppm F NaF group had significantly smaller DMFS increment than the 2000 ppm F SMFP group p < 0.005. The 2000 ppm F NaF group demonstrated an 18 per cent (26 per cent for children > 10 years at baseline) reduction in DMFS over the 1500 ppm F SMFP group, the 2500 ppm F group a 15 per cent (19 per cent) reduction, and the 2000 ppm F SMFP a 5 per cent (9 per cent) reduction. Results are strongest in children at greatest risk--older children with previous caries. This study concludes that the anticaries efficacy of SMFP dentifrices rises with increasing fluoride, and that the anticaries efficacy of a 2000 ppm NaF dentifrice is superior to that of a 2000 ppm F SMFP dentifrice, p < 0.005). nan In this double-blind trial, the anticaries effectiveness of a test toothpaste formulated for young children with 550 ppm F was compared with that of a positive control toothpaste containing 1055 ppm fluoride. More than 3000 2-year-old children were enrolled in the study and after 3 years of toothpaste use, 2177 (72 per cent) were examined. From a clinical and radiographic assessment, more than half the children were found to be caries free and only 32 (1.5 per cent) had evidence of rampant caries. There appeared to be little or no difference between children who had used test or control pastes, either in caries or in plaque levels. On the basis of this clinical trial the experimental toothpaste with 550 ppm fluoride would appear to have a similar anticaries efficacy to that of the control toothpaste. Differences were seen in relation to sex of the child and to social class. Girls had lower levels of plaque than boys but more carious teeth. Children from families in higher social classes had fewer carious teeth and lower levels of plaque. 751 14- and 15-year old children completed a 3-year, double-blind, caries preventive program. The effects of daily, supervised toothbrushing with an 0.76% sodium monofluorophosphate dentifrice, rinsing with a 0.05% sodium fluoride mouthrinse, and the combined effects of the two treatments were investigated. Both the dentifrice and mouthrinse reduced the incidence of dental caries, but their combined use at the same time had no greater effect than either used alone. The objective of this two-year comparative investigation was to assess the anticaries efficacy of three dentifrices commercially available in China. Two products contained the stated active agent sodium monofluorophosphate (SMFP) at a concentration of 1.14%; one was calcium carbonate-based, the second was silica-based. The third dentifrice tested contained no fluoride and was calcium carbonate-based.
                Prior to the start of this double-blind, parallel-group study, all aspects of the study were reviewed and approved by the human review committee of the West China College of Stomatology, Sichuan University. All parents signed the approved consent form before the initial evaluations. A total of 1200 qualifying children living in the Chengdu, China area entered the study, and 998 children completed all aspects of the study. Subjects were randomly assigned to use one of the three dentifrices: 328 participants used the non-fluoride calcium carbonate-based dentifrice; 341 participants used the 1.14% SMFP silica-based dentifrice; and 329 participants used the 1.14% SMFP calcium carbonate-based dentifrice. Participants were instructed to brush their teeth with their assigned dentifrice twice daily. Brushing instructions were reinforced.
                At the baseline examination, the mean dfs (decayed and filled tooth surfaces) scores of the non-fluoride dentifrice group (3.60 +/- 6.07),the 1.14% SMFP silica-based dentifrice group (3.53 +/- 5.62), and the 1.14% SMFP calcium carbonate-based dentifrice group (3.54 +/- 5.34) were not statistically different (p > 0.05). After one year, the mean dfs increment of the non-fluoride dentifrice group was 2.19 +/- 4.12, 1.69 +/- 3.12 for the 1.14% for the SMFP silica-based dentifrice group, and 1.53 +/- 3.09 for the 1.14% SMFP calcium carbonate-based dentifrice group; after two years, the mean dfs increments were 4.73 +/- 5.17, 2.98 +/- 4.42, and 2.75 +/- 4.33, respectively. Both the 1.14% SMFP calcium carbonate-based and the 1.14% SMFP silica-based dentifrices provided significantly more caries reduction than the non-fluoride silica-based dentifrice after one year (-30% and -23%) and two years (-42% and -37%) of product use. The 1.14% SMFP calcium carbonate-based dentifrice was not significantly different from the 1.14% SMFP silica-based dentifrice after one and two years of use.
                The results of this clinical study indicate that the 1.14% SMFP calcium carbonate-based and the 1.14% SMFP silica-based dentifrices are effective against tooth decay compared to brushing with a non-fluoride toothpaste. nan nan nan Experimental evidence has clearly demonstrated that the early stages of lesion formation (enamel demineralization) are reversible following exposure to saliva and/or fluoride. Clinical evidence for remineralization has also been reported extensively in the literature. However, the literature is lacking with respect to data from well-controlled clinical studies regarding the quantitative contribution of remineralization to arrestment and reversal of caries. Retrospective analysis of an existing clinical trial database provided an opportunity to examine the incidence of clinical lesion reversals in a placebo-controlled, double-blinded caries clinical study. The clinical study examined three treatment groups: 1) 0.243% sodium fluoride/silica dentifrice, 2) 0.4% stannous fluoride/calcium pyrophosphate (positive control) dentifrice and 3) non-fluoridated placebo/calcium pyrophosphate (negative control) dentifrice. Clinical measures in this study included both radiographic and visual-tactile assessments of caries. Examination of all subjects revealed a statistically greater frequency for caries reversals in the sodium fluoride group as compared to the placebo group at Year 3, for both total and radiographic caries. In contrast, while caries reversals in the stannous fluoride group occurred with greater frequency than in the placebo group at Year 3, for both total and radiographic caries, the differences were not statistically significant. When only subjects who were "at risk" for potential reversals (i.e., those with a minimum of one carious lesion at baseline) were examined, a statistically greater frequency in caries reversals was observed in both the sodium fluoride (total, incipient, and radiographic caries) and stannous fluoride (total and radiographic caries) groups as compared to the placebo group at Year 3. Collectively, these data confirm the ability of both 0.243% sodium fluoride/silica and 0.4% stannous fluoride/calcium pyrophosphate dentifrices to clinically reverse caries. The results suggest that sodium fluoride may deliver a greater frequency of caries reversals than stannous fluoride, although these treatments were not found to be significantly different. nan nan Aluminum salts have demonstrated anticaries activity in a number of laboratory and animal studies. The aim of this double-blind, pilot, clinical trial was to evaluate the effect of an alum (Al) mouthrinse on dental caries formation both by itself and in combination with an ADA-approved sodium fluoride (F) dentifrice. A total of 260 caries-prone children residing in a low-F area were preselected for the study and scored independently for caries by two experienced examiners. After using gender, age, and initial DMFT(S) scores for baseline stratification, the subjects were assigned to one of three treatment regimens: (1) placebo mouthrinse and F dentifrice, (2) Al mouthrinse and placebo dentifrice, and (3) Al mouthrinse and F dentifrice. The alum mouthrinse contained 500 ppm Al and the sodium fluoride dentifrice contained 1100 ppm F. Rinsing was supervised at school on weekdays for 30 sec/day, while the dentifrices were used ad libitum at home. Subjects were reexamined for caries and oral health after six and twelve months. Both examiners found that children who used Al mouthrinse, in conjunction with either placebo or F dentifrices, had lower caries incidence than those who used placebo mouthrinse/F dentifrice combination; but the differences were statistically significant for only one of the examiners. No evidence of deleterious effects to the oral tissues was observed. The results of this pilot clinical trial demonstrated that daily supervised use of an alum mouthrinse inhibited caries development in decay-prone children at least as effectively as a F dentifrice. A three-year double blind clinical caries trial was undertaken to compare the anticaries efficacy of three types of active agent, namely sodium fluoride (NaF), sodium monofluorophosphate (SMFP) and the combination of NaF plus sodium trimetaphosphate (TMP), using two fluoride levels (1000 ppm F and 1500 ppm F). The prime objective of the study was to determine whether there was any difference in the anticaries efficacy between NaF and SMFP. The second objective was to assess the effect on caries protection of the incorporation of TMP into a NaF dentifrice formulation. The study was carried out to FDI protocol and involved 4,294 children aged 11-12 years at outset. These participants had been selected from a pool of 6,212 potential subjects on the basis of caries experience and dental eruption pattern. They were stratified by sex, examiner, presence of calculus and caries, and allocated at random to one of the six toothpastes under study. Clinical examinations were carried out at baseline and thereafter annually for 3 years. Bitewing radiographs of a subset of children were taken at baseline and at the end of the study. The outcome measure for the study, DMFS increment, was defined as the increase in caries over three years, taking into account changes occurring on individual tooth surfaces. After three years, clinical-only data for 3,517 children were available for the calculation of caries indices. The mean three-year DMFS increment for subjects using a dentifrice containing NaF alone was 6.4 per cent lower than for those using a dentifrice containing SMFP. The difference between the NaF+TMP users and the SMFP users was 8.1 percent.(ABSTRACT TRUNCATED AT 250 WORDS)
This review confirms the benefits of using fluoride toothpaste in preventing caries in children and adolescents when compared to placebo, but only significantly for fluoride concentrations of 1000 ppm and above. The relative caries preventive effects of fluoride toothpastes of different concentrations increase with higher fluoride concentration. The decision of what fluoride levels to use for children under 6 years should be balanced with the risk of fluorosis.