Influences of directed research and clinical observations on the development of a tartar control whitening dentifrice.

Early literature described the benefits of cleaning the mouth and teeth to prevent tartar accumulation and tooth loss. For more than a century, the need for meticulous tooth scaling and regular brushing to maintain oral health has been recorded. More recently, because of innovative research into the chemical and biological activity of saliva, dentifrices have been formulated which specifically interrupt the mineralization of plaque and food debris to stain and calculus. Proof of efficacy of these dentifrices are obtained with well-designed clinical tests which quantify stain and calculus by using reliable scoring systems.

Clinical efficacy of a triclosan/copolymer pre-brush rinse.

A five-day, double-blind parallel clinical study was conducted to determine the effect on plaque removal of a pre-brush rinse containing 0.03 triclosan (Irgacare MP, Ciba-Geigy Corp.) and 0.125% of a copolymer of methoxyethylene and maleic acid (Gantrez, GAF Corp.), as compared to a matching placebo pre-brush rinse. One hundred eleven subjects were stratified into two balanced groups according to baseline Quigley-Hein Plaque Index scores. Each group was randomly assigned to use either the triclosan/copolymer pre-brush rinse or the matching placebo pre-brush rinse. In order to determine plaque removal efficacy of the pre-brush rinses, subjects rinsed their mouths twice daily (mornings and evenings) for one minute with 15 ml of their assigned pre-brush rinse. Immediately after rinsing, subjects brushed their teeth for 30 seconds with a commercially available dentifrice containing 0.76% sodium monofluorophosphate and a soft-bristled toothbrush. The morning rinsing/brushing procedure was done under supervision at the clinical facility. The evening rinsing/brushing procedure was done at home. After five days' use of their assigned pre-brush rinse and toothbrushing, subjects were evaluated by the dental examiner for residual plaque using the modified Quigley-Hein Plaque Index scoring procedure. When mean five-day Quigley-Hein Plaque Index scores were compared for both groups, the triclosan/copolymer pre-brush rinse removed 22.54% more plaque from all surfaces of the teeth than the matching placebo pre-brush rinse. When mean Quigley-Hein Plaque Index decrements (the difference between baseline and five-day Quigley-Hein Plaque Index scores) were compared for both groups, the triclosan/copolymer pre-brush rinse removed more than twice as much plaque from all surfaces of the teeth than the matching placebo pre-brush rinse (33.99% efficacy versus 15.19% efficacy). When mean five-day Plaque Severity Index scores were compared for both groups, the triclosan/copolymer pre-brush rinse removed 46.15% more plaque from the "more difficult to brush" surfaces of the teeth than the matching placebo pre-brush rinse. rinse.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical comparison of the anticalculus efficacy of three commercially available dentifrices.

A three-month, double-blind, parallel and unsupervised clinical study was conducted to compare the effects on supragingival calculus formation of the following four dentifrices: 1) A placebo dentifrice containing 0.243% sodium fluoride in a silica base. 2) A commercially available anticalculus dentifrice containing 5.0% soluble pyrophosphate in a 0.243% sodium fluoride silica base. 3) A commercially available anticalculus dentifrice containing 1.3% soluble pyrophosphate and 1.5% of a Gantrez copolymer in a 0.243% sodium fluoride silica base. 4) A commercially available anticalculus dentifrice containing 3.3% soluble pyrophosphate and 1.0% of a Gantrez copolymer in a 0.243% sodium fluoride silica base. The three-month results indicated that the three commercially available anticalculus dentifrices provided statistically significant reductions (at the 99% level of confidence) in supragingival calculus formation of 43.87%, 46.60%, and 51.32% respectively, as compared to the placebo dentifrice. There was no statistically significant difference among the three commercially available anticalculus dentifrices.

Clinical efficacy of an anticalculus fluoride dentifrice containing triclosan and a copolymer: a 6-month study.

A 6-month, double-blind, parallel and unsupervised clinical study was conducted to compare the effects on supragingival calculus formation of a dentifrice containing 0.3% triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride/silica base, as compared to a placebo dentifrice containing 0.243% sodium fluoride in a silica base. Subjects were initially stratified into two balanced groups based on their Volpe-Manhold calculus index scores that were obtained from a 3-month pre-test period using a placebo dentifrice. All subjects received an oral prophylaxis and were assigned to the use of either the fluoride/triclosan/copolymer dentifrice or the placebo dentifrice. Seventy adult male and female subjects completed the entire 6-month study. The results after 3-months' use of their respective dentifrices indicated that the subjects using the fluoride/triclosan/copolymer dentifrice had 26.34% less supragingival calculus formation than the subjects using the placebo dentifrice. This reduction in supragingival calculus was significant at the 99% level of confidence. The results after 6 months indicated that the subjects using the fluoride/triclosan/copolymer dentifrice had 36.27% less supragingival calculus formation than the subjects using the placebo dentifrice. This reduction was significant at the 99% level of confidence.

Anticalculus effect of a fluoride dentifrice containing triclosan and a copolymer.

A 3-month, double-blind, parallel and unsupervised clinical study was conducted to compare the effects on supragingival calculus formation of a dentifrice containing 0.3% triclosan and 2.0% of a copolymer, as compared to a placebo dentifrice. Subjects were initially stratified into two balanced groups based on their Volpe-Manhold Index calculus scores obtained from a 3-month pre-test period using a placebo dentifrice. All subjects received an oral prophylaxis and were assigned to the use of either a dentifrice containing 0.3% triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride/silica base or a placebo dentifrice containing 0.243% sodium fluoride in a silica base. A total of 79 adult male and female subjects completed the study. The results after 3-months' use of their respective dentifrices indicated that the subjects using the triclosan/copolymer dentifrice had 26.34% less supragingival calculus formation than the subjects using the placebo dentifrice. This reduction in supragingival calculus was significant at greater than 97% level of confidence.

Long-term evaluation of a prebrushing dental rinse for the control of dental plaque and gingivitis.

One hundred and three adults completed a double-blind, 6-month controlled study to assess the effects of rinsing with Plax (Oral Care Division of Pfizer Inc., New York, NY) before brushing on plaque, gingivitis and calculus. All the parameters were evaluated at baseline and after three and six months of home use of either Plax or placebo rinse. Microbiological components of plaque were monitored. Following prolonged use as a prebrushing rinse, Plax was no more effective than placebo in reducing plaque, gingivitis and calculus.

New perspectives on Sanguinaria clinicals: individual toothpaste and oral rinse testing.

Clinical studies conducted since 1983 on oral care products containing sanguinaria extract have yielded a variety of results. A careful review of these trials suggests that the designs used to conduct many of these trials may have had affected the study outcomes. Review of these trials suggests that studies testing the efficacy of anti-plaque products exercise the following guidelines: 1) use parallel instead of crossover designs, 2) select appropriate study populations, 3) use sufficient numbers of subjects to ensure statistical power, 4) select appropriate controls, 5) ensure intra- or inter-rater reliability prior to the start of the study, and 6) use proper statistical methodology. This review was undertaken to provide perspective into the results of these early studies, and furnish the rationale for the planning of subsequent clinical testing of sanguinaria-containing products.

Correlations among gingival indices: a methodology study.

Using an experimental gingivitis model, 99 subjects completed a 3-week study to determine the correlations between a visual index of gingivitis, the Modified Gingival Index (MGI), and the Gingival Index (GI), the Interdental Bleeding Index (IBI), and the Papillary Bleeding Index (PBI). Following a baseline examination consisting of the MGI and either the GI, IBI, or PBI, each subject received a full mouth scaling and rubber cup polishing to render the teeth plaque and calculus free. Subjects then rinsed twice daily for 30 seconds with 20 ml of either an active antimicrobial or control mouthrinse for 3 weeks while abstaining from all other oral hygiene. The MGI correlated significantly with the GI, IBI, and PBI, both at baseline and at 3 weeks for all subjects.

A study to compare the effects of two dentifrices on adult dental calculus formation.

In a three month double-blind clinical trial, a tartar control dentifrice formulation containing soluble pyrophosphates was compared to a placebo formula. Both formulations contained sodium fluoride. Subjects on the active dentifrice showed a 38% reduction in calculus severity and a 25% increase in calculus-free sites compared to the placebo group. Despite obvious differences in inactive excipients, these values are similar to reported results from other commercially available tartar control dentifrices. No untoward side effects occurred throughout the test period.

Reduced formation of supragingival calculus with use of fluoride-zinc chloride dentifrice.

Results of this comparative, double-blind, clinical study show that fluoride dentifrice with 2.0% zinc chloride is effective in reducing calculus accumulation after a dental prophylaxis. The data also confirm earlier observations on calculus formation in that accumulation was not constant during the two 3-month study phases.

Clinical studies of plaque control agents: an overview.

Dental plaque is massed packed bacterial cells which accumulate on the supra- and subgingival surfaces of the teeth as well as on the oral mucosa. The microorganisms of plaque have been shown to be associated with both dental caries and periodontal disease. This overview of clinical studies of plaque control agents reviews the properties and effects of chemical compounds which have demonstrated a potential for the control of plaque microorganisms. The search for clinically effective antiplaque agents has been stimulated by findings in laboratory and animal studies of plaque dynamics. Based upon these in vitro and in vivo experiments, chemotherapeutic agents such as antibiotics, antiseptics, enzymes, detergents, bacteriosides, antimetabolites, and oxidizing agents have been evaluated against human plaque microorganisms using the ultimate biological model -- man. Continued study of chemotherapeutic agents should be encouraged because many of these drugs have been shown to be safe for human use and may require only the development of a delivery system to potentiate their concentration in a specific local site. Use of these chemotherapeutic agents, which can be self-administered, becomes an attractive way of providing the public with a cost-effective method of preventing caries and periodontal disease.