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The antimicrobial effect of a triclosan/copolymer dentifrice on oral microorganisms in vivo.

BACKGROUND: The authors compared the in vivo antimicrobial effects on microorganisms from dental plaque, saliva and the tongue in subjects who used a triclosan/copolymer dentifrice and a fluoride dentifrice (control). METHODS: The authors assigned 15 subjects randomly to the control dentifrice or the triclosan/copolymer dentifrice for twice-daily use for one week. They collected samples of plaque, saliva and tongue scrapings six and 12 hours after the final brushing. They analyzed colony-forming units of Veillonella species, Fusobacteria species, total cultivable anaerobes and hydrogen sulfide (H(2)S)-producing bacteria. A one-week washout followed. The authors repeated the protocol with the second dentifrice. RESULTS: The results showed no differences at baseline. Significant reductions (88 to 96 percent) in oral anaerobic bacteria were observed in the triclosan/copolymer group six and 12 hours after brushing compared with the control group (P = .001). Fusobacteria decreased by 77 to 92 percent and Veillonella decreased by 84 to 89 percent six and 12 hours after brushing in the triclosan/copolymer group versus the control group. The triclosan/copolymer group also demonstrated a significant decrease in H(2)S-producing bacteria six and 12 hours after brushing (74 to 85 percent) (P = .001). CONCLUSIONS: Brushing with the triclosan/copolymer dentifrice resulted in significant reductions in microorganisms from the three sites compared with the control dentifrice. CLINICAL IMPLICATIONS: The triclosan/copolymer dentifrice produced sustained effects on oral bacteria for 12 hours.

Adult↗

Fluoride dentifrice ingestion and fluorosis of the permanent incisors.

BACKGROUND: Fluoride dentifrice is a primary means of preventing childhood caries, but it is also an important risk factor for fluorosis. The authors examine the influence of fluoride dentifrice ingestion on fluorosis of the permanent incisors. METHODS: Participants in the Iowa Fluoride Study received questionnaires at regular intervals concerning fluoride sources. The authors assessed fluorosis using the fluorosis risk index. They estimated daily fluoride ingestion from dentifrice, diet and fluoride supplements and divided the amount by kilograms of body weight. The statistical analysis related fluoride ingestion to fluorosis in the permanent incisors. RESULTS: In bivariate analyses, mild fluorosis was significantly related to ingestion of fluoride dentifrice at ages 24 and 36 months (P = .02 for both). After the authors adjusted for fluoride ingested from dietary sources, logistic regression showed a significant association between fluorosis and dentifrice ingestion at age 24 months (P = .04). CONCLUSIONS: The study results suggest that fluorosis of the permanent incisors is influenced by ingestion of fluoride dentifrice during the first three years of life. Further research is needed to assess total intake of fluoride as a risk factor for fluorosis. CLINICAL IMPLICATIONS: These results support recommendations that young children use only a pea-sized amount of dentifrice. Parents should supervise young children as they brush their teeth with fluoride dentifrice.

Age Factors↗

Visual evaluation of in vitro cariostatic effect of restorative materials associated with dentifrices.

This study evaluated in vitro the cariostatic effect of 6 restorative materials with and without fluoride release (Fuji II LC, F-2000, Degufil Mineral, Sure Fil and Z-250) associated with a fluoridated and a non-fluoridated dentifrice (Sensodyne Original Formula and Sensodyne Sodium Bicarbonate), on human enamel. Class V-like cavities were prepared on 240 enamel slabs, assigned to 12 groups (6 materials and 2 dentifrices). After cavity restoration, the slabs were submitted to a thermocycling regimen of 1000 thermal cycles and demineralization/remineralization cycles. During pH cycles, slurries of fluoridated and non-fluoridated dentifrices were applied for 5 min. Formation of artificial caries-like lesions was scored independently and blindly by 5 calibrated examiners according to an ordinal scale ranked 0 to 3 by visual examination. The results were analyzed statistically by the Kruskal-Wallis test and pair-wise comparisons (alpha=0.05). There were no significant differences (p>0.05) among the restorative materials associated with the fluoridated dentifrice. When used in association with the non-fluoridated dentifrice, Ketac-Fil showed the highest cariostatic effect followed by Fuji II LC and the other materials. Ketac-Fil was the only material that did not differ statistically when combined with either the fluoridated or the non-fluoridated dentifrice. In conclusion, under the tested experimental conditions, the association of restorative materials and fluoridated dentifrice yielded higher cariostatic effect, except for the conventional glass ionomer cement, whose cariostatic effect was not influenced by the type of dentifrice.

Bisphenol A-Glycidyl Methacrylate↗

A long term clinical study evaluating the effect of two dentifrices on oral tissues.

1. A long term (54 months) supervised, double-blind human clinical study has been conducted to ascertain whether the routine use of a commercially available cosmetic dentifrice, with purported stain removal and flavor impact characteristics, would cause adverse manifestations in the oral tissues, as compared to the similar use of a more conventional type of commercially available dentifrice. 2. One hundred and twenty male and female subjects (aged 12 to 70) were randomly assigned to the use of one of the two dentifrices under investigation, after which they used the assigned dentifrices twice daily (1 min each brushing) under supervised conditions for a period of 54 months. 3. Clinical examinations were conducted on all subjects initially (base line), and at 3-month intervals throughout the 54-month course of the study. This examination included a complete and thorough inspection of the oral soft and hard tissues. 4. The results after 54 months of continuous use of the dentifrices (representing a total dentifrice/oral tissues exposure time of approximately 45 hours per subject) indicated that neither of the two dentifrices caused any adverse reactions of the oral soft tissues and that both dentifrice groups had similar patterns and levels of cervical abrasion and/or erosion. 5. The results also indicate a lack of direct correlation between laboratory abrasivity values (as determined by a radioactive dentin abrasion procedure) and the clinical situation, thus suggesting that factors other than dentifrice abrasivity may play an important role with regard to tooth wear.

Adolescent↗

Fluoride availability and stability of Japanese dentifrices.

The decline of dental caries in the industrialized countries can be attributed to widespread use of fluorides. The Japanese market share of dentifrices containing fluorides has increased from 12% in 1985 to 77% in 2000. For a fluoride dentifrice to be effective in the control of dental caries, an adequate concentration of the fluoride must be soluble. Several Japanese fluoride dentifrices have in their formulations calcium phosphate as an abrasive, which may react with fluoride. This study was designed to evaluate the availability and stability of fluoride in the most consumed dentifrices in Japan. The analyses were made when the dentifrices were purchased (fresh samples) and after one year of storage (aged samples) at room temperature (21.8 +/- 3.6 degrees C). Total fluoride and soluble fluoride was determined using an ion specific electrode. All dentifrices showed similar concentrations of total fluoride in fresh and aged samples in accordance with the Japanese Legislation (content of less than 1,000 ppm F). Some dentifrices, with dicalcium phosphate as abrasive, showed decreasing concentrations of total soluble fluoride and increasing amounts of insoluble fluoride over time. Although most of the Japanese fluoridated dentifrices evaluated in this study contain unstable fluoride, they were found to have sufficient concentrations of soluble fluoride to be effective in preventing dental caries.

Biological Availability↗

Clinical comparison of two tartar control dentifrices: a twelve-week study.

The objective of this double-blind clinical study was to investigate the anticalculus efficacy of a new improved tartar control dentifrice formulation containing tetrasodium pyrophosphate, sodium tripolyphosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica base (New and Improved Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals) as the test dentifrice, compared to a previously marketed, American Dental Association-accepted, tartar control dentifrice formulation containing tetrasodium pyrophosphate, PVM/MA copolymer and 0.243% sodium fluoride in a silica base (Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals), as the positive control dentifrice. Adult male and female subjects were entered into the study based on a pre-test (baseline) Volpe-Manhold calculus index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice using a soft-bristled toothbrush. Examinations for the formation of supragingival dental calculus were performed after twelve-weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol and completed the entire study. At the 12-week examination, the test dentifrice group exhibited a statistically significant (p < 0.0008) 44.1% reduction in the mean Volpe-Manhold calculus index score compared to the mean calculus scores of the previously marketed, positive control dentifrice group. Thus, the results of this clinical study support the conclusion that the New and Improved Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals is more efficacious in controlling the development of supragingival calculus formation than the previously marketed Colgate Tartar Control Fluoride Toothpaste with Micro-Cleaning Crystals.

Adolescent↗

The clinical effectiveness of a dentifrice containing triclosan and a copolymer for providing long-term control of breath odor measured chromatographically.

The objective of this double-blind clinical study was to investigate the effectiveness of a commercially available dentifrice containing triclosan and a copolymer (Colgate Total Toothpaste) for controlling long-term, i.e., seven-hour and overnight breath odor. In particular, a comparison was made between the level of control of breath odor provided by the test dentifrice, and that provided by a placebo dentifrice which did not contain triclosan or a copolymer. This study followed a two-treatment, two-period crossover design. Prospective subjects were provided with a supply of a commercially available fluoride dentifrice, which was used for a one-week period prior to the two seven-day treatment periods. During each treatment period, subjects were instructed to brush their teeth twice a day, morning and evening, for sixty seconds with their assigned study dentifrice, using the soft-bristled toothbrush which had been provided. On the morning following the seventh day of each treatment period, subjects reported to the clinical facility for overnight breath odor assessments. Directly following this, subjects brushed their teeth, ate and drank normally, and reported once again to the clinical facility at seven hours post-toothbrushing for another breath odor assessment. Prior to the overnight breath odor assessments, subjects refrained from brushing their teeth, rinsing their mouths or using breath mints, and from eating or drinking anything on the morning of the evaluation. Subjects refrained from the use of tobacco products, and from eating onions, garlic, or strong spices throughout the entire study. Breath odor was instrumentally evaluated by measuring the level of volatile sulfur compounds in the mouth air using a 565 Tracor gas chromatograph equipped with a flame photometric detector. Measurements were taken in duplicate, and then averaged. Levels of volatile sulfur compounds were expressed in nanograms per milliliter (ng/ml) of mouth air. The two dentifrices exhibited statistically significant differences (p < 0.05) with respect to both overnight breath odor and seven-hour post-toothbrushing breath odor. The mean overnight breath odor scores were 9.63 ng/ml for Colgate Total Toothpaste, and 12.64 ng/ml for the placebo dentifrice. For seven-hour breath odor, the mean scores were 5.62 ng/ml for Colgate Total Toothpaste, and 7.10 ng/ml for the placebo dentifrice. Thus, the results of this double-blind clinical study on 19 subjects support the conclusion that Colgate Total Toothpaste provides effective seven-hour and overnight control of breath odor.

Adult↗

Use of fluoridated dentifrice and glucose retention at the approximal areas of anterior teeth.

The present study was undertaken to learn to what extent the use of dentifrice with fluoride affected glucose retention after glucose rinsing. Fifty-eight subjects consisting of forty male adults and eighteen female adults whose average age was 21.9 years were divided at random into two groups; one group used fluoridated dentifrice and the other group used nonfluoridated dentifrice. Subjects rinsed their mouths for fifteen seconds with 20 mL of 0.5 M glucose solution. Samples of saliva were taken from the approximal areas between the right and left central incisors of the maxilla and mandible by inserting the tip portion of a paper point three-minutes after the glucose rinsing, sample of saliva were taken from the neighboring approximal areas of the left central and left lateral incisors. Glucose content of the paper points was determined using the enzyme membrane method. Determinations were made before and at the end of the first, third, and fifth month over a five-month period. Fluoride concentrations in the resting saliva were also determined in different months during this period. At three-minutes and six-minutes, glucose retention in the group using fluoridated dentifrice was found to decrease slightly throughout the experiment; while glucose retention in the group on nonfluoridated dentifrice leveled off or increased in the fifth month. Fluoride concentration in the resting saliva increased during the experiment in the group using fluoridated dentifrice; while fluoride concentration in the group using nonfluoridated dentifrice did not change. It was concluded that the regular use of fluoridated dentifrice made glucose retention slightly lower and fluoride level in whole saliva higher.

Adult↗

Plaque regrowth effects of a triclosan/pyrophosphate dentifrice in a 4-day non-brushing model.

Triclosan is a lipophilic antimicrobial agent which, when present in an aqueous dentifrice vehicle, is complexed by or in close contact with polymers and surface-active molecules, emulsifying agents, flavoring oils and other hydrophobic ingredients. Because of this, dentifrice products containing triclosan may not have triclosan in a bioavailable state and, hence, the products themselves can not be assumed to possess antimicrobial activity. In order to determine the antimicrobial effects on dental plaque of a triclosan/pyrophosphate dentifrice relative to a negative control (without triclosan or pyrophosphate), a crossover 4-day non-brushing study was conducted. Thirty-four subjects were enrolled in this randomized two-period, double-blind crossover investigation with thirty-three subjects completing all aspects. Following a baseline plaque examination and complete plaque removal at the start of the first 4-day treatment period, subjects initiated a twice-daily supervised dosing regimen, during which they rinsed with their first assigned dentifrice in slurry form while refraining from tooth-brushing and all other oral hygiene procedures. Evaluations to quantify test product effects on plaque were conducted on Day 5. After a week-long interim washout period, subjects repeated the twice daily rinsing regimen over Days 1-4 of Treatment Period 2 with their second assigned product, again with examinations on Day 5. Analysis of data demonstrated subjects had significantly (p = 0.0296) less plaque when rinsing with the triclosan/pyrophosphate dentifrice slurry as compared to the negative control dentifrice slurry; the relative treatment difference as determined by the primary examiner was 12.7%. A trainee examiner observed a 16.0% reduction on a subset of subjects (p = 0.0139). This efficacy result compares favorably with results from other studies of triclosan-containing products. The examinations for oral safety demonstrated no meaningful clinical differences between the triclosan/pyrophosphate dentifrice and control dentifrice.

Adult↗

Effects of a tartar control whitening dentifrice on tooth shade in a population with long-standing natural stain.

Changing and whitening tooth color in people with long-standing tooth stain without excessive hard tissue abrasion may represent one of the more difficult challenges for whitening dentifrices. An eight-week clinical trial was conducted to evaluate change in tooth color by a silica-based, enamel-safe tartar control whitening dentifrice compared to a marketed baking soda dentifrice control. First, a screening exercise was conducted to identify individuals with long-standing extrinsic dental stain. This exercise targeted adults who reported "stained teeth" and coffee/tea drinking or smoking, but who had no recent history of dental prophylaxis. Targeted subjects were examined for stain (Lobene Index) and tooth shade/color (Vita). A total of 291 adults having extrinsic stain and discolored teeth were enrolled in the study. Subjects were randomized to one of the two treatment groups, and all dentifrice use was unsupervised. Tooth color was measured at 4 and 8 weeks from shade values collected from the 8 incisors, and averages were determined from a linear ordering of the shade guide. A total of 278 evaluable subjects completed the 8-week study. Overall, the tartar control whitening dentifrice group experienced an improvement in color, differing statistically from baseline (p < 0.001) and from the marketed control (p < 0.05). Safety profiles for the two dentifrices were generally similar. Among patients with long-standing extrinsic stain, use of the tartar control whitening dentifrice resulted in superior overall tooth shade and reduced maximum or worst color compared to the marketed baking soda dentifrice control.

Adult↗

Maintenance of tooth color after prophylaxis: comparison of three dentifrices.

Pellicle rapidly accumulates on tooth surfaces after prophylaxis and may acquire cosmetically unacceptable levels of stain. A three-month clinical trial was conducted to evaluate stain prevention by a new silica-based tartar control whitening dentifrice (Crest Extra Whitening) compared to marketed tartar control baking soda peroxide whitening and regular dentifrice controls. Prior to the trial, a one-month screening exercise was conducted to identify adult subjects who accumulated extrinsic tooth stain after dental prophylaxis. A total of 672 subjects were stratified based on tooth whiteness, gender and tobacco usage, then given a dental prophylaxis and randomized into one of three dentifrice treatment groups. All product use was unsupervised. Change in tooth whiteness (delta L*) was determined by comparing colorimeter measurements collected on the facial surfaces of the four central incisors at months 1 and 3 to baseline. Ninety-six percent of subjects completed the three-month study. At both one and three months, the two whitening dentifrices did not differ from baseline in terms of delta L*. In contrast, the regular control had delta L* values of -0.26 and -0.39 at one and three months, respectively, differing significantly from baseline at both time points. Each of the whitening dentifrices differed statistically from the regular control in stain accumulation (p < or = 0.001) at one and three months, but were not different from each other. In general, all three test dentifrices were well tolerated. These data demonstrate the effectiveness of the new tartar control whitening dentifrice in preventing stain accumulation after dental prophylaxis compared to the marketed regular dentifrice control.

Adult↗

Reduction in dental caries with four concentrations of sodium fluoride in a dentifrice: a meta-analysis evaluation.

Information on the effects of fluoride concentrations above 1,100 ppm in dentifrices is not extensive in the literature. The objective of this meta-analysis was to examine and compare the anticaries effectiveness (in terms of DMFS scores) of 1,700 ppm, 2,200 ppm and 2,800 ppm F- ion (as sodium fluoride) dentifrices vs. an 1,100 ppm F- ion (as sodium fluoride) control dentifrice based on results from six double-blind, randomized clinical studies, each conducted over a two- to three-year period. The studies each enrolled approximately 1,200-2,000 male and female school children per treatment group in grades I through 8, and were conducted in areas with low fluoride content water supplies in the states of Indiana, Pennsylvania, Ohio and Oregon. Separate meta-analyses were performed on the study results (DMFS increment scores determined by visual-tactile examinations supplemented with radiographs) for the one-year, two-year and three-year examinations. Comparisons of the 1,700 ppm F-, 2,200 ppm F-, and 2,800 ppm F- groups vs. the 1,100 ppm F- group were based on pooling the effect sizes for these comparisons from the individual studies. The effect sizes were calculated in two different ways, reflecting the analyses that were performed in the original studies: 1) effects based on the sample means and variances; and 2) effects based on the adjusted sample means and mean squared error from an analysis of covariance. The results obtained from this meta-analysis provide evidence that the use of a 2,800 ppm F- ion, as sodium fluoride, dentifrice results in statistically significantly lower caries increment than the use of an 1,100 ppm F- ion, as sodium fluoride, dentifrice. This result was noted after one, two, and three years of dentifrice use. The 1,700 ppm F- and 2,200 ppm F- dentifrice groups showed some directional advantages over the 1,100 ppm F- dentifrice group, however the analysis did not establish these groups as statistically significantly better than 1,100 ppm F-. The meta-analysis based on analysis of covariance results was somewhat more sensitive to treatment group differences than the analysis based on sample means and variances, as was expected.

Adolescent↗

A clinical study to assess the anticalculus efficacy of a new dentifrice containing a special grade of silica (Colgate Total Plus Whitening Toothpaste): a clinical trial on adults.

The objective of this double-blind clinical study, conducted using the Volpe-Manhold design for studies of dental calculus, was to confirm the supragingival anticalculus efficacy of a formulation variant of a commercially available anticalculus dentifrice. The commercially available dentifrice (Colgate Total Toothpaste) contains 0.3% triclosan and 2.0% PVM/MA copolymer in a 0.243% sodium fluoride/silica base. The new formulation variant contains those same ingredients, of which 10% of the silica is a high cleaning grade (Colgate Total Plus Whitening Toothpaste). In this study, the dentifrice formulation variant was tested for anticalculus efficacy against a negative control dentifrice containing 0.243% sodium fluoride/silica. Adult male and female subjects from the northern New Jersey area were entered into the study based on a pre-test (baseline) Volpe-Manhold Calculus Index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex, and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after eight weeks' use of the study dentifrices. Sixty-three (63) subjects complied with the protocol and completed the entire study. At the eight-week examination, subjects in the Colgate Total Plus Whitening Toothpaste group exhibited a statistically significant 34.13% reduction in mean Volpe-Manhold Calculus Index score as compared to the negative control dentifrice group. Thus, the results of this clinical study support the conclusion that a new dentifrice formulation variant containing a special grade of silica (Colgate Total Plus Whitening Toothpaste) is efficacious for the control of the formation of supragingival calculus.

Adult↗

Desensitizing efficacy of a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride.

PURPOSE: To evaluate the relative effectiveness provided by a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength) for reducing dentin hypersensitivity over an 8-wk period, as compared to that provided by a commercially-available antihypersensitivity dentifrice containing 5.0% potassium nitrate and 0.76% sodium monofluorophosphate in a dicalcium phosphate base (Fresh Mint Sensodyne dentifrice). MATERIALS AND METHODS: To qualify for participation in this examiner-blind study, male and female adults from the San Francisco, California area were required to present with tactile and air blast dentin hypersensitivity in at least 2 non-molar teeth at two examinations, spaced 1 wk apart. Qualifying subjects were randomized into two treatment groups, which were balanced for gender, age, and baseline sensitivity scores. Subjects were provided with a soft-bristled toothbrush. Examinations for tactile and air blast sensitivity were repeated after 4 wks' use of the study dentifrices, and again after 8 wks' usage. RESULTS: 101 subjects complied with the protocol, and completed the entire study. After 4 wks, subjects assigned to the Colgate Sensitive Maximum Strength group exhibited a statistically significant improvement over the Fresh Mint Sensodyne dentifrice group with respect to tactile sensitivity scores, and a statistically significant improvement over the Sensodyne dentifrice group with respect to air blast sensitivity scores. Correspondingly significant improvements were presented after 8 wks. Thus, the results of this examiner-blind clinical study support the conclusion that Colgate Sensitive Maximum Strength dentifrice provided superior levels of control of tactile and air blast sensitivity than did the clinically tested, commercially-available Sensodyne anti-hypersensitivity dentifrice.

Adult↗

Effects of triclosan/copolymer dentifrice on dental plaque and gingivitis in a 3-month randomized controlled clinical trial: influence of baseline gingivitis on observed efficacy.

Triclosan is a broad-spectrum antimicrobial agent widely used in oral care products. In recent studies, a triclosan/pyrophosphate dentifrice has shown efficacy against dental plaque but not gingivitis. Further, experimental gingivitis studies on triclosan itself and in combination with other dentifrice ingredients demonstrate only moderate antimicrobial activity. In contrast, there are a number of other studies in the literature reporting the antigingivitis efficacy of triclosan/copolymer and triclosan/zinc citrate dentifrices. These dentifrices possess similar effects on dental plaque to triclosan/pyrophosphate, thus the lack of effect on gingivitis from triclosan/pyrophosphate was unexpected since comparable effects on dental plaque from similar formulations may infer similar antimicrobial activity and duration of action within the oral cavity. Therefore, the objective of this research was to understand the clinical variables important to observe the reported effects for triclosan dentifrice so this clinical model could in turn be used to test the effects of the triclosan/pyrophosphate dentifrice on gingivitis. To achieve this objective, it was determined that a suitable approach was to duplicate the methodology of previous successful clinical trials on triclosan/copolymer dentifrice in order to better understand the study design used to demonstrate the antigingivitis efficacy of triclosan-containing dentifrices. To this end, a prospective trial was conducted employing the same active product, clinical site, investigator and gingivitis/plaque examiner previously used. The study was a randomized, blinded, placebo-controlled, parallel group 3-month trial, which recruited subjects with Löe-Silness Gingival Index (GI) scores > or = 1.0 and Turesky Plaque Index (PI) scores of > or = 1.5. The study population consisted of 160 adults who brushed twice daily with either triclosan/copolymer or placebo control (containing copolymer) following a prophylaxis. Gingivitis and plaque were measured using the GI and PI, respectively, and scores were analyzed using a one-way analysis of covariance. There was no evidence that 3-month gingivitis or plaque scores (whole mouth or severity index) for the triclosan/copolymer group were different from the placebo group. Additional analyses were conducted on study population subgroups with increasing intervals of baseline GI bleeding sites to gauge the effect of baseline bleeding on the treatment effect. For subjects in the > or = 40 bleeding sites subset, triclosan/copolymer demonstrated a 4.2% GI and 15% gingivitis severity index reduction versus placebo at 3 months (0.10 < p < 0.20). These findings suggest that a study design which includes subjects with greater numbers of gingival bleeding sites at baseline may have the required sensitivity to demonstrate treatment benefits for triclosan/copolymer. However, additional experimental parameters remain to be fully articulated in order to replicate previously successful trials. The overall results of this trial are consistent with the experimental gingivitis results, and indicate that, even when formulated with the copolymer, triclosan as an oral antimicrobial agent possesses limited activity as an antigingivitis ingredient.

Adult↗

The stain prevention efficacy of two tooth whitening dentifrices.

An 8-week randomized, double-blind, parallel group clinical study was conducted to assess the extrinsic stain prevention efficacy of three commercially available dentifrices: 1) a dentifrice containing 0.243% sodium fluoride with copolymer, tetrasodium pyrophosphate, and sodium tripolyphosphate in a silica base (Product 1); 2) a dentifrice containing 0.243% sodium fluoride, baking soda and peroxide, tetrasodium pyrophosphate, and sodium tripolyphosphate in a silica base (Product 2); and 3) a dentifrice containing 0.243% sodium fluoride in a silica base (Product 3). After the collection of baseline stain scores by a trained examiner and a subsequent oral prophylaxis, 126 volunteers were randomized to one of the three treatment groups (balanced for composite extrinsic stain scores). Throughout the 8-week treatment period, subjects brushed their teeth twice daily with their assigned dentifrice. At baseline, 4-, and 8-week evaluations, extrinsic dental stain was measured on the facial surfaces of the six maxillary anterior teeth and on the facial and lingual surfaces of the six mandibular anterior teeth using the Lobene Index. A total of 120 subjects completed the study. No adverse events were reported, and subjects who discontinued the study did so for reasons unrelated to the dentifrices. At the 4-week evaluation, composite stain scores were statistically significantly lower (P < .05) for both Product 1 (44.9%) and for Product 2 (34.6%) relative to Product 3. At the 8-week evaluation, composite stain scores were statistically significantly lower (P < .05) for both Product 1 (28.4%) and for Product 2 (29.6%) relative to Product 3. The results of this clinical study demonstrate that both dentifrices, one containing 0.234% sodium fluoride with copolymer, tetrasodium pyrophosphate, and sodium tripolyphosphate in a silica base; and one with 0.243% sodium fluoride with copolymer, tetrasodium pyrophosphate, and sodium tripolyphosphate in a silica base are more effective in preventing natural extrinsic stain formation on teeth as compared with a marketed control dentifrice.

Adult↗

Inhibition of calculus formation by dentifrice formulations containing essential oils and zinc.

PURPOSE: To examine the effect of three essential oil-containing dentifrice formulations with different zinc salts and concentrations on dental calculus formation in rats. MATERIALS AND METHODS: A total of 150 rats were randomly distributed into five litter and sex-matched groups of 30. They were maintained on a calculogenic diet and topically treated twice daily with undiluted dentifrices. Each experimental dentifrice formulation contained a zinc salt, a fixed combination of essential oils (i.e. eucalyptol, menthol, methyl salicylate, and thymol) and a hydrated silica abrasive. Commercial zinc-free and zinc-containing dentifrices were included as negative and positive controls, respectively. After 17 days calculus was scored post-mortem on molar teeth. RESULTS: All groups of rats treated with zinc-containing dentifrices had significantly (P < 0.05) lower mean calculus scores than the group treated with a zinc-free control dentifrice. Other variables (e.g. fomulation type, essential oil content, zinc salt and concentration) did not significantly affect calculus scores. Thus, all three essential oil/zinc-containing dentifrices and a commercial, zinc-containing, tartar-control dentifrice inhibited calculus formation in this rat model.

Analysis of Variance↗

The laboratory and clinical safety evaluation of a dentifrice containing hydrogen peroxide and baking soda.

This study reports the laboratory, clinical, and microbiological finding of the safety testing and daily use of a dentifrice delivering 0.75% hydrogen peroxide and 5% baking soda. Laboratory studies using Ca45 labeled teeth and biologically stained teeth confirmed that the dentifrice did not decalcify enamel or bleach teeth. Over the course of a six-month period, 62 subjects using a hydrogen peroxide-baking soda dentifrice and 21 subjects using a control dentifrice were examined for oral soft tissue change and hard tissue alterations. No soft tissue changes attributable to the use of either dentifrice were noted. Experienced clinicians using Trubyte shade guide teeth observed no significant changes to the subjects' anterior teeth following 6 months use of the test dentifrice. Paired discrimination tests revealed that the examiners could distinguish color differences in the shade guide teeth at 0.7%. Microbiological monitoring of the subjects for six months use of their assigned dentifrice and for the following months on the control dentifrice, revealed neither an increased incidence of candida nor increased candida counts.

Adult↗