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As compared to a toothpaste without periodontal-prophylactic adjuncts, the commercially available silka toothpaste exerted a statistically significant beneficial effect on the chronically inflamed gingivae. Thus, a periodontal-prophylactic efficiency may be attributed to the Silka toothpaste.
A six-month, double-blind clinical study was entered into by three hundred twenty-five (325) male and female adult subjects to assess the efficacy of a dentifrice containing 0.3% triclosan (Irgacare MP, Ciba-Geigy Corp.) and 2.0% of a copolymer of methoxyethylene and maleic acid (Gantrez, ISP Corp.) on supragingival plaque formation and gingivitis, compared to a placebo dentifrice over a six-month period. Each dentifrice, the triclosan and the placebo, contained 0.243% sodium fluoride in a silica base. Only those subjects who were free of periodontal disease (no pockets > 4 mm), demonstrated a level of at least mild gingivitis (modified Loe-Silness score > or = 1.0) and had a modified Quigley-Hein Plaque Index score of > or = 1.5 were admitted into the study. Baseline plaque and gingivitis scores were used to stratify the subjects into two balanced groups. A thorough oral prophylaxis was administered to all subjects. They were then assigned either the triclosan/copolymer dentifrice or the placebo dentifrice to use for the next six months. Evaluation for gingivitis and supragingival plaque formation was made after three and six months. Evaluations made after six (6) months demonstrated a 17.0% statistically significant (at the 99% level of confidence) reduction in supragingival plaque formation was provided by the triclosan/copolymer dentifrice, compared to the placebo dentifrice. An 18.6% statistically significant (at the 99% level of confidence) reduction in plaque formation on the tooth surfaces with the highest plaque formation was provided by the triclosan/copolymer dentifrice, compared to the placebo dentifrice.(ABSTRACT TRUNCATED AT 250 WORDS)
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.
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.
A total of 159 adult male and female subjects between 18 and 63 years of age, were entered into a 6-month, double-blind clinical study to assess the effects of a dentifrice containing 0.3% triclosan and 2% of a copolymer of methoxyethylene and maleic acid on supragingival plaque formation and gingivitis, as compared to a placebo dentifrice. Both the triclosan and placebo dentifrices contained 0.243% sodium fluoride in a silica base. The subjects had to demonstrate at least mild gingivitis (modified Loe-Silness score > or = 1.0), be free of advanced periodontal disease, have a modified Quigley-Hein Plaque Index score of at least 1.5 and have a minimum of 20 natural, uncrowned teeth. The subjects were stratified into two balanced groups according to baseline plaque and gingivitis scores. At zero time or baseline, all subjects received a complete and thorough oral prophylaxis and were assigned to the use of either the placebo dentifrice or the triclosan/copolymer dentifrice for the next 6 months. Subjects were evaluated for gingivitis and supragingival plaque formation after 3 and 6 months product use. After 3 months, when compared to the placebo dentifrice, the triclosan/copolymer dentifrice provided the following statistically significant reductions (at 99% confidence levels): (1) a 10.0% reduction in supragingival plaque formation; (2) a 20.8% reduction in plaque formation on tooth surfaces with highest baseline plaque scores; (3) a 21.9% reduction in gingivitis, and (4) 30.5% less sites with severe gingivitis, i.e. gingival bleeding.(ABSTRACT TRUNCATED AT 250 WORDS)
In a 3-year clinical trial the effect of daily supervised toothbrushing with a dentifrice containing sodium fluoride/silicon dioxide and a dentifrice containing sodium monofluorophosphate/calcium phosphate and calcium carbonate was investigated. Initially about 400 children aged 9-11 years from one school in Malmö took part in the study. They were randomly divided into two groups. Each group brushed their teeth daily in school under the supervision of a dental hygienist. The children and their families were given the corresponding dentifrices for home use. The children were examined for caries at the start of the study and again after an interval of 1 year by the same dentist and according to the stated criteria. A comparison of the caries increments in the two dentifrice groups revealed a statistically significantly lower caries increment during the 2nd and 3rd experimental years in the sodium fluoride dentifrice group compared with the sodium monofluorophosphate dentifrice group.
The study groups using a dentifrice and mouthrinse both containing fluorides, a dentifrice containing stannous fluoride and a mouthrinse containing sodium fluoride, or a mouthrinse containing sodium fluoride with a placebo dentifrice had a 20.7% to 29.0% lower DMF increment than the control group after 30 months. These differences were significant. The study groups using a dentifrice containing amine fluorides and a placebo mouthrinse, a mouthrinse containing amine fluorides and a placebo dentifrice, or a dentifrice containing stannous fluoride and a placebo mouthrinse had a 13.6% to 22.4% lower DMF increment than the control group. These differences were not statistically significant. There was no significant difference in effectiveness against caries between the use of the organic or inorganic fluoride products.
A total of 294 adult male and female subjects completed a 6-month, double-blind clinical trial designed to evaluate the effects of a dentifrice which contained 0.3% triclosan in conjunction with 2% of a methoxyethylene/maleic acid copolymer in a 0.243% sodium fluoride/silica base, relative to a control dentifrice, on supragingival plaque accumulation and gingivitis. Plaque and gingivitis were scored after 3 and 6-month use of the assigned dentifrice. At the end of the study, the triclosan group showed an average reduction, relative to the control group, of 12% in plaque accumulation and 20% in gingivitis. Both were statistically significant at p < or = 0.0001. The effect of the triclosan dentifrice was most pronounced on the more severe manifestations of plaque and gingivitis. The improvement in the gingival parameters at 6-months relative to the control dentifrice was statistically significant at p < or = 0.0001. It was concluded that the twice-daily use of the triclosan-containing dentifrice resulted in significant reduction in supragingival plaque formation and a significant improvement in gingival health without the presence of any extrinsic staining or objectionable taste.
Ingestion of fluoride dentifrice by preschool children recently has been implicated as a risk factor for dental fluorosis. The availability of dentifrices flavored for children could increase fluoride ingestion by young children at risk for dental fluorosis. This article reports results of a pilot study of use of regular-flavored dentifrice and those flavored for children among 29 preschool children. Using a crossover design, larger quantities of fluoride dentifrice specially flavored for children were used compared with the quantities of regular-flavored dentifrice. Pediatric dentists and other health care providers should advise parents to supervise preschoolers' toothbrushing. Preschoolers should use only small, pea-sized quantities of dentifrice to avoid increased risks of dental fluorosis.
Sensodyne F, a dentifrice currently marketed in the United Kingdom, containing potassium chloride (KCl) and sodium monofluorophosphate (MFP) was compared to a placebo dentifrice for effectiveness in alleviating dentinal hypersensitivity. This randomized, double-blind, parallel clinical study covered 12 weeks of product use by 41 subjects. Hypersensitivity levels of the affected teeth were assessed by tactile stimulation, cold air stimulation and overall subjective patient response. The results from these three methods of assessment demonstrated that the KCl/MFP dentifrice was significantly more effective than the placebo dentifrice in reducing dentinal hypersensitivity. The therapeutic response to the KCl/MFP dentifrice as measured by air sensitivity and overall subjective evaluation was statistically significant when compared to the placebo dentifrice within 4 weeks of use. Significant improvement was observed for all parameters at the conclusion of the 12-week clinical study period. Plaque reduction was significantly reduced at week 8 and continued to improve by week 12. The results indicate that KCl with sodium MFP significantly reduced dentinal hypersensitivity and improved overall patient comfort.
Althought the patient group was limited to persons with radiation-induced mucositis, lichen planus, and erythema multiforme, the study indicates the potential usefulness of a bland dentifrice to other patients with sensitive mouths. Although it is presumed that regular brushing habits will aid in oral hygiene and health, the specific effect of a bland dentifrice on control of plaque, caries, and periodontal disease cannot be assessed in this preliminary study. Also, no comparison was made with cleaning techniques in which dentifrice is not used. Therefore, this study indicated only that dentifrice with reduced flavor, like the one used in this study, may encourage better oral hygiene through continued brushing when irritation from regular dentifrices discouages it.
A study was undertaken in 24 human volunteer subjects to determine the possible effects of selected commercially available dentifrices on clinically normal masticatory mucosa. An acrylic stent was fabricated which was designed to hold four test dentifrices in close apposition to the palatal tissues for 1 hour. Evaluation approximately 8 hours later revealed pathologic responses which were evident clinically and histologically. 1. Clinically, palatal tissues exposed to Crest were not distinguishable from control areas, while Colgate (mfp), MacCleans, and Ultra Brite produced erythematous changes which were statistically significant when compared with adjacent control sites. 2. Histologically, epithelial changes were seen within the test sites which ranged from a parakeratin-like surface layer to necrosis and intraepithelial abcess formation. Control sites consisted of normal orthokeratinized palatal mucosa in all cases. 3. The more severe microscopic reactions were noted with MacCleans and Ultra Brite, while the milder reactions were associated with Colgate (MFP). Crest infrequently produced a parakeratin-like response. The response was not statistically significant when compared with controls. 4. The clinical and histologic reactions were generalized throughout the test population, suggesting that the responses were not due to individual hypersensitivity but due to irritation from one or more of the dentifrice components. Although the clinical significance of these findings could not be readily assessed, the potential for irritation of human palatal mucosa by selected dentifrices has been demonstrated. These findings support the suggestion by the World Workshop in Periodontics (1966)20 that efforts should be directed to the development of dentifrice materials less harsh to the oral tissues.
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.
2 strontium chloride hexahydrate-containing dentifrices (SCH), similar except for their respective abrasive systems, were compared in a 2-month randomised double-blind parallel clinical study to evaluate their comparative effectiveness in terms of cervical dentinal hypersensitivity. 2 groups of 20 subjects, each with cervical dentinal hypersensitivity, were evaluated for tactile sensitivity by Yeaple probe, air sensitivity using a dental air syringe and subjective perception of pain by means of a visual analogue scale. There was no difference between the dentifrices as regards reduction of cervical dentinal hypersensitivity at each time point. The response to both dentifrices was evident within 4 weeks of use and the degree of improvement increased throughout the 8-week study period. The results support the conclusion that changing the abrasive component of SCH dentifrices did not significantly increase or decrease the (desensitizing) activity of the original product.
A laboratory investigation of the fluoride dentifrices commonly used in Greece was done in order to evaluate their caries-preventive potential. The evaluation was based on the determination of the free ionic fluoride and the total soluble fluoride present by a potentiometric fluoride electrode technique. Dentifrices containing MFP, NaF and AlF3 were analyzed. The measured total soluble and free ionic fluoride content were discussed in conjunction with the various dentifrice components. Most of the examined dentifrices were MFP type and the free ionic fluoride was found to vary from 130 to 180 parts/10(6) F-.
Schoolchildren residing in a fluoride-deficient area were provided either a sodium fluoride (0.1% F) or a nonfluoride dentifrice for home use. About half the children provided each type of dentifrice were also given an initial prophylaxis. Combining the data with regard to the type of dentifrice indicated that the sodium fluoride dentifrice resulted in dental caries reductions of 24 and 26% as noted by the two examiners, respectively.
Dentin sensitivity is one of the most painful, ubiquitous, and least satisfactorily treated chronic problems of the teeth. The purpose of this clinical trial was to test the sensitivity-reducing effectiveness of five dentifrices over a six-week period. For the study, 176 adults, ages 18 to 63, exhibiting a total of 486 hypersensitive surfaces, were randomly allocated to five experimental groups to use one of the following: a strontium chloride dentifrice, a 0.4% stannous fluoride gel, a pluronic F-127-sodium citrate gel, a pluronic F-127 gel, or a control dentifrice. No specific instructions were provided as to the frequency or method of toothbrushing; thus, the participants brushed their teeth in their usual manner. The analysis of the data was limited to 168 persons who complied with study procedures. Chi-square analysis examined the statistical differences between the four test agents and the control formulation. The desensitizing effect of the pluronic plus sodium citrate gel was highly significant, and the plain pluronic F-127 preparation was effective to a lesser degree. Patients using the strontium chloride or stannous-fluoride-containing dentifrices did not exhibit a significant improvement over the control group. This study demonstrated that a pluronic polyol gel containing sodium citrate is highly effective in controlling tooth hypersensitivity.