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Short-term effects of different toothpaste formulations on total salivary calcium: A randomized crossover study.

OBJECTIVES: Dental calculus formation can be inhibited by toothpastes containing pyrophosphate, which chelates calcium ions and prevents hydroxyapatite crystal formation. Although pyrophosphate may also influence salivary calcium availability, the short-term effects of commercially available toothpaste formulations on salivary calcium concentrations remain insufficiently characterized. This study investigated and compared the short-term effects of three fluoride toothpastes on salivary calcium concentration. METHODS: A randomized, three-treatment, three-period crossover trial was conducted in 48 healthy volunteers. The participants used three commercially available sodium fluoride toothpastes in randomized order: a formulation containing methyl vinyl ether/maleic acid copolymer, PVM/MA copolymer (Sensodyne), a formulation containing pyrophosphate and zinc (Dentalux), and a formulation containing sodium bicarbonate (Parodontax). Treatment periods were separated by a 2-day washout. Unstimulated saliva was collected at baseline (T0), immediately after brushing (T1), 30 min (T2), and 60 min (T3). Salivary calcium concentrations were quantified using a colorimetric assay. Data were analysed using linear mixed-effects models with toothpaste formulation, measurement time, treatment sequence, and the toothpaste-by-time interaction as fixed effects and participant as a random effect. RESULTS: Significant effects were observed for toothpaste formulation (F(2,103.35)=42.31, P&#x2009;<&#x2009;0.001), measurement time (F(3,141)=39.78, P&#x2009;<&#x2009;0.001), and the toothpaste-by-time interaction (F(6,141)=23.91, P&#x2009;<&#x2009;0.001), whereas treatment sequence had no significant effect (P&#x2009;=&#x2009;0.927). Compared with Dentalux&#xae; and Sensodyne&#xae;, Parodontax&#xae; resulted in significantly lower salivary calcium concentrations (both Bonferroni-adjusted P&#x2009;<&#x2009;0.001), immediately after brushing (T1). The differences decreased after 30 min and were no longer significant after 60 min. No significant differences were observed between Dentalux&#xae; and Sensodyne&#xae; at any time point. CONCLUSIONS: Commercially available fluoride toothpastes produced different short-term effects on the salivary calcium concentration, with the greatest differences occurring immediately after brushing. Because the products differed in terms of multiple formulation ingredients, the findings reflect product-level effects rather than ingredient-specific effects. Further multicentre studies are warranted to confirm these findings and evaluate their clinical relevance.

Humans

Safety evaluation of toothpaste containing chloroform. III. Long-term study in beagle dogs.

Beagle dogs were given chloroform in a toothpaste base orally in gelatin capsules on 6 d/wk for 7 1/2 yr, followed by a 20-24 wk recovery period. Groups of 16 males and females received 0.5 ml/kg/d of the vehicle (toothpaste without chloroform) and 8 dogs of each sex remained untreated. Treated groups comprised 8 dogs of each sex remained untreated. Treated groups comprised 8 dogs of each sex, receiving doses equivalent to 15 and 30 mg CHCl3/kg/d in the toothpaste vehicle; another group of the same size received an alternative non-chloroform toothpaste (0.5 ml/kg/d). Eleven of the 96 dogs died during the study, only two of these being in the CHCl3-treated groups. The only significant toxic response during treatment was a moderate rise in serum enzyme levels (e.g. SGPT), reaching a peak in the sixth year of the study and probably corresponding to minimal liver damage. Few Palpable growths were noted while the dogs were alive. "Fatty cysts" were seen in the liver of several dogs at post mortem possibly associated with the chloroform treatment but the distribution of a nodular change in the liver was not obviously dose related. A small number of macroscopic and microscopic neoplasms were seen; one dog in each chloroform-treated group had a malignant tumour but there were no tumours in the liver or kidney of any dog. Overall, exposure to chloroform in a toothpaste base was not associated with any effect on the incidence of any kind of neoplasm. From this and related studies in mice and rats, it is concluded that repeated exposure to chloroform (3.5 percent) in toothpaste is unlikely to result in any hazard to human health.

Animals

Antimicrobial effect of four different toothpastes.

The study was undertaken to evaluate the antimicrobial effect of a commercial toothpaste, claimed to contain active chlorhexidine gluconate. Two traditional toothpastes and a 0.5% chlorhexidine gel were used as negative and positive control pastes. To exclude the effect of mechanical cleaning, all the agents were applied twice daily to the tooth surfaces by means of individually constructed acrylic cap splints. Ten dental students used each paste in a 4-week cross-over double-blind study comprising four test periods of 4 d duration. The students were allowed normal mechanical oral hygiene during the 3 d between the test periods. At the beginning and the end of each test period the tooth surfaces in the right halves of the jaws were scored for the Plaque Index, after which disclosing solution was used and the teeth of the left halves of the jaws were scored for stained plaque. Of all the toothpastes tested, only the chlorhexidine gel exhibited an antimicrobial effect comparable to that of efficient mechanical oral hygiene measures. The effect of the toothpaste with claimed chlorhexidine content did not differ from that of the two traditional toothpastes.

Bacteria

Acquisition of alkali-soluble fluoride by enamel through treatment with NaF-containing toothpastes in vitro.

The first aim of the present study was to examine if alkali-soluble fluoride (calcium fluoride-like material and adsorbed fluoride) forms when a NaF-containing toothpaste is applied on human enamel surface in vitro. The centrifuged supernatants of toothpastes dissolved in distilled water were used and four different commercial NaF-containing toothpastes were tested. The second aim was to investigate if pyrophosphate would interfere with the deposition of alkali soluble fluoride. The formation of alkali-soluble fluoride was determined by chemical analysis and visualized by scanning electron microscopy (SEM). It was ascertained that all tested toothpastes contained free fluoride according to the manufacturers' specifications. It was shown that they promoted deposition of alkali soluble fluoride on the enamel surface. The amount of deposited material increased with the time of exposure. The clinical effect of a NaF-containing toothpaste may thus well depend on an initial formation of alkali-soluble fluoride. Fluoride from this reservoir may adsorb onto the enamel crystals and inhibit further demineralization or increase the rate of remineralization during cariogenic challenges. It was also demonstrated that pyrophosphate did not interfere with the deposition of alkali soluble fluoride.

Adsorption

Contact allergy to toothpaste flavors.

Toothpaste flavors are fragrance mixtures. Oil of peppermint and spearmint, carvone and anethole are ingredients with a low sensitizing potential, but they are used in almost every brand of toothpaste and caused seven cases of contact allergy in a 6-year period at Gentofte Hospital. Toothpaste reactions are rare due to several reasons; local factors in the mouth, the low sensitizing potential of the flavors generally used, and the lack of recognition. It is emphasized that the toothpaste battery for patch testing has to be relevant and changed according to the consumers' and manufacturers' taste and fashion.

Anethole Trithione

Safety evaluation of toothpaste containing chloroform. I. Long-term studies in mice.

In three experiments, chloroform was administered to mice by gavage in a toothpaste base or in arachis oil, in doses up to 60 mg/kg/d on 6 days/wk for 8 wks. Control groups were left untreated or given vehicle only. In general, there were more survivors in chloroform-treated groups than in the controls. In the case of the males of three strains (C57BL, CBA and CF/1), treatment was associated with no adverse affect on the incidence of any type of neoplasm or any other parameter. In the males but not the females of a fourth strain (ICI) and in doses of 60 mg/kg/d but not of 17 mg/kg/d, exposure to chloroform in toothpaste base as a vehicle was associated with increased incidence of epithelial tumours of the kidney. A more pronounced effect of the same kind was seen in mice given 60 mg CHCl3/kg/d in an archis oil vehicle. This treatment was also associated with a higher incidence and severity of non-neoplastic renal disease. The mechanisms underlying the peculiar strain- and sex-specific susceptibility of ICI male mice to develop renal tumours when exposed to chloroform remain obcure; spontaneous renal tumours were also seen in vehicle control mice and possible ways in which this tendency may be enhanced by chloroform treatment are discussed. At the dose levels tested, namely 113 and 400 times average human exposure levels from the use of toothpaste (with 3.5 percent chloroform content), no adverse affect was seen in the liver and there was no increased incidence of liver tumours even in the higher liver tumour susceptible CBA strain. At the 17 mg CHCl3/kg/d level, equivalent to 113 times average human exposure from toothpaste use, no excess of renal tumours was seen even in males of the peculiarly susceptible ICI strain.

Animals

Effect of supervised use of a fluoride toothpaste on caries incidence in pre-school children.

Caries prevalence of children living in Helsinki is low and little further reduction has been seen during recent years. The aim of the study was to investigate whether a supervised daily brushing at school with a fluoride toothpaste containing 1.2% sodium monofluorophosphate reduced caries incidence in a well-controlled group of nursery-school children with low caries prevalence. A total of 87 children from two nursery schools formed the test group. A group of children matched for age, baseline dfs and follow-up time, who had attended the same nursery schools just before starting this prospective study and who had brushed their teeth daily at school without toothpaste, formed a retrospective control group. After the follow-up time (mean 1.4 years), the total number of new carious surfaces was 23 in the test group (mean 0.3) and 83 in the control group (mean 0.9); the difference was significant. In the test group 72% and in the control group 62% of children were caries-free after the follow-up period. The results suggest that the use of a fluoride toothpaste as an extra daily prophylaxis reduces caries incidence in pre-school children.

Chi-Square Distribution

Effect of socioeconomic factors on the observed caries reduction after fluoride tablet and fluoride toothpaste consumption.

The caries experience of 123 fluoride users (F-tablets and/or F-toothpaste) was compared with that of a group of 226 non-users. Fluoride users appeared to have a 15% lower DFS score (16.2) than non-users (19.0). After a matching procedure had been used to correct for some intervening variables (socioeconomic status, toothbrushing habit, sweet consumption) no difference was found between the groups of F-tablet and F-toothpaste users and the respective groups of matched non-users. The difference in caries experience of 15% between users and non-users remained in only one group after the matching procedure, that in which the children used both F-tablets and F-toothpaste.

Child

Oral use of chlorhexidine gluconate toothpaste in epileptic children.

The purpose of this clinical study was to evaluate the effect of a 3-min daily toothbrushing with 1% chlorhexidine gluconate toothpaste on dental plaque, gingivitis and gingival hyperplasia in 30 mentally retarded epileptic children treated with phenytoin. A double-blind cross-over technique was used. Brushing once daily for 2 months with 1% chlorhexidine gluconate toothpaste resulted in significantly lower Pl I and G I values. Gingival hyperplasia was not significantly reduced by the use of the chlorhexidine toothpaste.

Administration, Oral

Antibacterial activity of some triclosan-containing toothpastes and their ingredients.

The antibacterial activity of 4 triclosan-containing toothpastes was compared to a conventional fluoride dentifrice and triclosan and sodium lauryl sulphate (SLS), both singly and in combination. A panel of 17 bacteria was tested by an agar dilution method. At concentrations typical of those found in toothpastes, triclosan and SLS displayed approximately equal antibacterial activity. A paste containing triclosan and zinc citrate appeared more active than the other triclosan pastes which, in general, showed marginal superiority over the conventional paste. SLS, although included in dentifrice formulations for its detergent properties, may significantly contribute to the antibacterial profile of a product. The need for appropriate controls when evaluating experimental toothpastes is emphasized.

Aggregatibacter actinomycetemcomitans

[Management of gingival inflammation with active ingredients in toothpaste].

In order to study the effect of active additives in toothpastes, three different toothpastes were tested in 60 persons for a period of four weeks. The toothpastes used contained allantoin, pyridyl carbinol, alpha-tocopherol, potassium aluminum sulfate, and tartaric acid. In addition, a control paste without additives was used. In a double blind study plaque incidence of the Ramfjord teeth was determined by means of the indices of Silness and Löe and Quigley and Hein. The tissue reactions were studied by means of the S-B index and the keratinization index. After an initial examination for extablishing the origianl values, the indices were determined after 2 and 4 weeks. Statistical analysis of the data obtained allows the conclusion that none of the tested active additives in the concentrations applied had any applied had any medicamentous influence on the gingival inflammation. The therapeutical consequences are discussed.

Administration, Topical

Sensitivity to cinnamic aldehyde in a toothpaste. 2. Further studies.

The authors carried out further studies to assess the significance of the findings of patients sensitive to cinnamic aldehyde in a toothpaste. Selected groups of patients in whom sensitivity to this might have been overlooked were patch-tested. With the exception of three patients, two with cosmetic sensitivity and one with hand eczema, the results were negative. The frequency of use of the original toothpaste was assessed among patients attending the clinic and this was followed by a circular letter to general practitioners and dentists inviting referral of patients with oral symptoms. As a result, five further cases, four of whom gave positive patch test reactions to cinnamic aldehyde, were discovered. The authors emphasize the importance of attempting to obtain accurate information as quickly as possible when 'new' or hitherto unsuspected allergens are implicated.

Acrolein

Contamination of toothpaste and toothbrush by Streptococcus mutans.

Toothbrushes and toothpaste tubes used by persons infected with S. mutans were examined for the presence of this microorganism. Fifteen minutes after brushing greater than 10(6) S. mutans were isolated from the toothbrushes and after ordinary storage for 24 h 10(4) were recovered. From two out of 10 toothpaste tubes S. mutans was isolated from the orifice of the tube. The implications of these findings for the spread of the microorganism are discussed.

Dentifrices

[Clinical analysis of the sodium-fluoride and sodium-monofluorophosphate content of Colgate toothpaste].

After six weeks use of Colgate toothpaste (1000 ppm MFP and 450 ppm NaF) in case of 50 individuals (25 test and 25 control persons) both the Plaque Index of Silness and Löe and the modified Sulcus Bleeding Index--"bleeding on probing" (Mühlemann and Son) mean values showed a significant decrease. According to the results of cytological testing the effect of toothpaste containing MFP and NaF proved favourable. The investigation of the ionisable plaque fluoride content produced statistically significant rise in plaque fluoride content.

Adult

Polishing effect and abrasion of five toothpastes on dental enamel.

Prepared enamel samples were polished with one of 5 different toothpastes, dulled by acid treatment and repolished with the same toothpaste. The lustre change was measured by reflectometry and the micromorphological aspects of abrasion on enamel were investigated with the scanning electron microscope.

Acid Etching, Dental

Safety evaluation of toothpaste containing chloroform. II. Long term studies in rats.

The results of a preliminary rangefinding 13-wk oral toxicity study and of two longer term studies on chloroform in toothpaste base are reported. Significant changes in serum enzymes and certain haemotological parameters were seen at the higher dose-levels in the rangefinding study. Intercurrent disease made it necessary to terminate the first long-term experiment prematurely after 1 yr. No evidence of serious toxicity was recorded. In the second long-term experiment, groups of 50 caesarian-derived SPF Sprague-Dawley rats of each sex received either the equivalent of 60 mg CHCl3/kg/d in toothpaste base or the vehicle only, by gavage on 6 d/wk for 80 wk and were then observed for up to a further 15 wk. Chloroform-treated rats of both sexes survived better than the controls, though both groups had a high incidence of non-neoplastic respiratory and renal disease. Female rats gave a consistent finding of decrease in plasma cholinesterase, shown to be related to activity against butyrylcholine but not acetyl-beta-methylcholine. Tumours of various sites were seen in 39 percent of chloroform-treated rats of both sexes examined histologically, compared with 38 percent of vehicle controls. There were no treatment-related effects on the incidence of liver or kidney tumours. Histologically-malignant mammary tumours were reported in more treated than control rats, but the difference in incidence was not statistically significant.

Animals

[The effect of toothpaste on the gingiva].

Under standarized conditions, foils are applied and removed from the attached gingiva of the mandibular anterior region. The amount of epithelial cells clinging to the test foils was determined. When compared to toothpastes with the usual content of surface active substances, the short contact of a toothpaste containing a high percentage of wetting agents increases the number of epithelial cells loosened by mechanic forces.

Cell Adhesion