Clinical efficacy in reducing dentin hypersensitivity of a dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride compared to a dentifrice containing 8% strontium acetate and 1040 ppm fluoride under consumer usage conditions before and after switch-over.

OBJECTIVE: The objective of this 16-week, double-blind, randomized, switch-over design study was to compare the efficacy in reducing dentin hypersensitivity of a dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (Colgate Sensitive Pro-Relief [also marketed as elmex Sensitive Professional]) to a desensitizing dentifrice containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride (Sensodyne Rapid Relief) under relevant consumer usage conditions. METHODS: Qualifying subjects from the San Francisco, CA, USA area, who presented two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale), participated in this two-phase double-blind study. Subjects were randomly assigned to one of two test groups. The first phase of the study consisted of twice-daily at-home brushing with the first assigned dentifrice for eight weeks. The second phase of the study consisted of switching product use to the second assigned dentifrice for a second eight-week period. Dentin hypersensitivity examinations, which comprised tactile and air blast hypersensitivity measures, as well as examinations of oral hard and soft tissues, were conducted at baseline, at the completion of the first study phase, and at two weeks and eight weeks of the second phase. RESULTS: One-hundred and twenty-one subjects complied with the study protocol and completed the study. Study Phase I: Subjects who brushed twice daily for eight weeks with the arginine/calcium carbonate dentifrice experienced statistically significant improvements in mean tactile and air blast hypersensitivity scores (51.3% and 39.4%, respectively) relative to that experienced by subjects who brushed with the strontium acetate dentifrice. Study Phase II: Subjects who brushed with the arginine/calcium carbonate dentifrice for the first eight weeks of the study and then switched to brush with the strontium acetate dentifrice for the second eight weeks of the study, did not exhibit further improvements in mean tactile or mean air blast hypersensitivity scores after two and eight weeks of switch-over product use. However, subjects who brushed with the strontium acetate dentifrice for the first eight weeks of the study and then switched to brush with the arginine/calcium carbonate dentifrice exhibited statistically significant improvements in mean tactile and air blast hypersensitivity scores two weeks (35.2% and 29.9%, respectively) and eight weeks (40.3% and 35.3%, respectively) after product switch-over. Relative to the subjects who switched from twice-daily brushing with the arginine/calcium carbonate dentifrice to brush with the strontium acetate dentifrice, those who switched from brushing with the strontium acetate dentifrice to brush with the arginine/calcium carbonate dentifrice exhibited statistically significant improvements in mean tactile hypersensitivity scores (10.3%) and in mean air blast hypersensitivity scores (16.3%) eight weeks after product switch-over. CONCLUSION: Eight weeks of brushing with Colgate Sensitive Pro-Relief(elmex Sensitive Professional) provides significant reductions in mean dentin hypersensitivity relative to the identical use of Sensodyne Rapid Relief. Additionally, the dentin hypersensitivity reductions achieved by twice-daily brushing with Sensodyne Rapid Relief are significantly improved by switching to twice-daily brushing with Colgate Sensitive Pro-Relief (elmex Sensitive Professional) for two and eight weeks. Further, the dentin hypersensitivity reductions achieved by twice-daily brushing with Colgate Sensitive Pro-Relief (elmex Sensitive Professional) are not improved by switching to twice-daily brushing with Sensodyne Rapid Relief for two or eight weeks. Eight weeks' use of Colgate Sensitive Pro-Relief (elmex Sensitive Professional), after having used Sensodyne Rapid Relief for an initial eight-week time period, provides statistically significant improvements in dentin hypersensitivity relative to eight weeks' use of the Sensodyne Rapid Relief.

The clinical effect of a single direct topical application of a dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride on dentin hypersensitivity: the use of a cotton swab applicator versus the use of a fingertip.

OBJECTIVE: The primary objective of this examiner-blind, randomized clinical study was to compare the effect of a toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), in providing instant relief of dentin hypersensitivity when delivered as a single direct topical application using a cotton swab applicator versus using a fingertip. A secondary objective was to evaluate the effect on dentin hypersensitivity of the dentifrice after seven days of twice-daily at-home brushing, subsequent to the single direct topical application performed at the beginning of the study. METHODS: Qualifying subjects possessed two baseline-designated hypersensitive teeth with a tactile hypersensitivity score of 10 to 50 grams of force (Yeaple Probe), and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale). In the first phase of the study, subjects topically self-applied the test product using a fingertip, a previously validated method, for one of the hypersensitive teeth (fingertip test teeth), and a cotton swab applicator for the second hypersensitive tooth (swab test teeth). In the second phase of the study, subjects brushed with the test dentifrice twice daily for seven days. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted immediately after direct topical product application, and after the subsequent seven-day brushing period. RESULTS: Eighty-four subjects complied with the study protocol and completed the study. Immediately after direct topical application, the fingertip test teeth and the swab test teeth exhibited statistically significant (p <0.05) improvements from baseline in mean tactile hypersensitivity scores (191.7% and 182.1%, respectively), and mean air blast hypersensitivity scores (58.1% and 56.3%, respectively). After the seven-day brushing period, the fingertip test teeth and the swab test teeth continued to exhibit statistically significant (p < 0.05) improvements from baseline in mean tactile hypersensitivity scores (191.7% and 190.5%, respectively) and mean air blast hypersensitivity scores (57.4% and 58.2%, respectively). No statistically significant (p > 0.05) differences were indicated between the fingertip test teeth and the swab test teeth with respect to mean tactile hypersensitivity scores or mean air blast hypersensitivity scores immediately after topical application (3.4% and 4.4%, respectively), or after seven days of twice-daily brushing with the product (0.41% and -1.90%, respectively). CONCLUSION: The results of this examiner-blind clinical study support the conclusions that 1) both fingertip and cotton swab methods of application provide significant reductions in dentin hypersensitivity immediately after a single direct topical application of the 8.0% arginine-calcium carbonate dentifrice, 2) when topical application is followed by seven days of twice-daily brushing with the dentifrice, the sensitivity relief obtained instantly after topical application is maintained, and 3) after topical application and after seven days of brushing, neither method of topical application provided a level of control of dentin hypersensitivity that differed significantly from the other.

Effects of liquid nitrogen cryotherapy and bone grafting on artificial bone defects in minipigs: a preliminary study.

Liquid nitrogen cryotherapy has been advocated as an adjunct in the enucleation and curettage of locally aggressive lesions of the jaws. Simultaneous autogenous bone grafting has also been advocated to accelerate bone formation and reduce morbidity. There is, however, relatively little scientific basis for either of these hypotheses. In this study, nine Yucatan minipigs had artificial defects created in the mandible, which were treated with liquid nitrogen spray. Half of the defects were grafted with autogenous bone from the chin and half were closed primarily. Two animals were sacrificed 3 days postoperatively to measure the width of necrosis and the rest were sacrificed at 3 months to assess healing and new bone formation. It was found that drilling the artificial defects alone caused bone necrosis for a mean depth of 0.09 mm. Liquid nitrogen cryospray caused a mean depth of bone necrosis of 0.82 mm (range 0.51-1.52 mm). The defects that were bone grafted healed well clinically. Defects not bone grafted showed a 50% rate of wound breakdown and sequestrum formation with delayed healing. Vital staining showed a non-significantly greater rate of bone formation in the grafted defects. Digitally superimposed radiography showed a non-significantly greater bone density in the non-grafted defects at 3 months postoperatively. It appears that liquid nitrogen cryospray does devitalize an area of bone around defects in the mandible. The width of necrosis is usually less than 1 mm and subsequent healing is enhanced by autogenous bone grafting. This has clinical implications.

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.

A randomized clinical trial of the desensitizing efficacy of three dentifrices.

The effect on dentinal hypersensitivity from the use of a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.) over an 8-week period was compared to a commercially available dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (positive control [Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.]) and to a commercially available nondesensitizing dentifrice containing 0.243% sodium fluoride in a silica base (negative control [Colgate Winterfresh Gel, Colgate-Palmolive Co.]). A total of 120 participants were stratified into 3 balanced groups according to baseline mean air blast (thermal) and tactile (Yeaple Probe) sensitivity scores, gender, and age. Participants brushed their teeth twice daily (morning and evening) for 1 minute. Dentinal hypersensitivity examinations were conducted at baseline, 4 weeks, and 8 weeks by the same dental examiner. After 4- and 8-weeks' use of their assigned products, participants in the new dentifrice group demonstrated statistically significant improvements (p < 0.05) in tactile and air blast sensitivity, as compared to those using the positive and negative control dentifrices.

Efficacy of a dentifrice containing 5% potassium nitrate and 1500 PPM sodium monofluorophosphate in a precipitated calcium carbonate base on dentinal hypersensitivity.

The effect on dentinal hypersensitivity from the use of a dentifrice containing 5.0% potassium nitrate, 1500 ppm sodium monofluorophosphate in a precipitated calcium carbonate (PCC) base over an eight-week period was compared to a placebo dentifrice without potassium nitrate. A total of forty-eight subjects were entered into the study and stratified into two balanced groups according to their baseline mean thermal (air blast) and tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the potassium nitrate/PCC dentifrice or a placebo dentifrice without potassium nitrate. The two groups were well balanced with regard to their mean baseline thermal tactile sensitivity scores, sex and age. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations, which included tactile and thermal sensitivity, were conducted at baseline, four weeks, and eight weeks. Examinations were conducted by the same dental examiner (TS) on the subjects at each examination. After four weeks' use of their assigned products, those subjects in the potassium nitrate/PCC dentifrice group demonstrated statistically significant improvements (p < 0.0001), as compared to the placebo dentifrice without potassium nitrate, in tactile and thermal sensitivity. After eight weeks' use of their assigned products, those subjects in the potassium nitrate/PCC dentifrice group again demonstrated statistically significant improvements (p < 0.0001), in tactile and thermal sensitivity, as compared to the placebo dentifrice without potassium nitrate. Thus it can be concluded from this study that the use of a dentifrice containing 5.0% potassium nitrate and 1500 ppm sodium monofluorophosphate in a precipitated calcium carbonate (PCC) base is a clinically effective method for reducing dentinal hypersensitivity.

Clinical efficacy of an optimized stannous fluoride dentifrice, Part 4: A 3-month calculus clinical study, northwest USA.

The objective of this 3-month, double-blind study was to investigate the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice for the control of supragingival dental calculus accumulation. After 3 months' use, the COSF dentifrice group exhibited a statistically significant 56.6% reduction in supragingival calculus formation, as compared to the control dentifrice group. The results of this study support the conclusion that the COSF dentifrice is efficacious for controlling the accumulation of supragingival calculus.

Adherence of two film-forming medications to the oral mucosa.

This study provides a comparison among 10 patients of old and new formulas of Zilactin (Zila Pharmaceuticals, Phoenix). The original formula contained tannic acid; the new formula replaced tannic acid with benzyl alcohol as the active ingredient. The U.S Food and Drug Administration's (FDA) ruling that tannic acid must be eliminated as the active ingredient from the Zilactin formula was the reason for the change. In the study, no side effects were reported for either formula, except for a minor burning sensation at the time of application. Moreover, the new Zilactin formula, on average, provided a statistically significant rate of adherence of 21 percent to the oral mucosa.

The comparative efficacy of two commercial tartar control dentifrices in preventing calculus development and facilitating easier dental cleanings.

Tartar control dentifrices have been proven effective in reducing the build-up of supragingival calculus deposits between professional tooth cleanings. In addition to providing consumers with a cleaner dentition, these formulations can, in principle, contribute to easier professional tooth cleaning. Until recently, clinical methods for evaluating the effects of tartar control dentifrices were limited to the assessment of area coverage of calculus on the tooth surface. The development of the Quanticalc dental scaler permits the quantitative clinical measurement of force and stroke number associated with supragingival calculus debridement. In this clinical study, two commercial tartar control dentifrices, one containing 5.0% pyrophosphate as the tartar control agent and the other containing a combination of 1.3% pyrophosphate and 1.5% Gantrez copolymer, were compared for efficacy in reducing the development of supragingival calculus between prophylaxes, and in facilitating easier calculus removal in subsequent scaling. Results showed that the two commercial dentifrices were equally effective in reducing calculus extent between prophylaxes. In contrast, the 5.0% pyrophosphate dentifrice was observed to be almost twice as effective on a percentage basis as the lower dosage pyrophosphate dentifrice in facilitating easier calculus removal. The enhanced activity of the 5.0% pyrophosphate dentifrice may be postulated to be due to elevated dosage of tartar control crystallization inhibitor or to potential side effects of copolymer in the other commercial dentifrice. Importantly, these results substantiate that the clinical benefits of tartar control dentifrices are not completely described by actions in reducing calculus build-up as assessed by VMI, and that important clinical benefits and differences in efficacy may be provided by these formulations in facilitating easier dental cleaning of supragingival calculus.

Anticalculus efficacy of three dentifrices.

PURPOSE: To evaluate the anticalculus effect of three commercial dentifrices. MATERIALS AND METHODS: A 12-week independent and double-blind clinical study was conducted on a population of calculus-forming adult male and female subjects in Budapest, Hungary to directly compare the anticalculus efficacy of three commercially-available dentifrices, as compared to a placebo dentifrice. The three commercially-available anticalculus dentifrices compared in this clinical study to a 0.243% sodium fluoride/silica placebo dentifrice were as follows: (1) A dentifrice containing 1.3% soluble pyrophosphate and 1.5% of a PVM/MA copolymer in a 0.243% sodium fluoride/silica base. (2) A dentifrice containing 0.3% triclosan and 2% of a PVM/MA copolymer in a 0.243% sodium fluoride/silica base. (3) A dentifrice containing 0.3% triclosan and 0.75% zinc citrate in a 1.14% sodium monofluorophosphate/silica base. RESULTS: All three anticalculus dentifrices provided statistically significant reductions in supragingival calculus formation, as compared to a placebo dentifrice, after 12 weeks of use. The reductions in supragingival calculus formation ranged from 39% to 55%, as compared to a placebo dentifrice, for the three commercially-available anticalculus dentifrices. There was no statistically significant difference among the three commercially-available dentifrices with regard to anticalculus efficacy.

Assessment methods and clinical outcomes: chemical and microbial composition, formation, and maturation dynamics of pellicle, plaque, and calculus.

Understanding the functional dynamics of the oral cavity helps researchers design methods to predict clinical outcomes. Most information about the oral cavities of companion animals must be drawn from animal studies designed to understand human oral disease and from human studies. Based upon functional criteria for any animal or experimental research study, supragingival plaque and calculus can be assessed within four to six weeks. Although longer studies may be more appealing, such study designs may compromise the oral soft tissue health of the animals and are complicated by oral cavity dynamics. Thus, they are less sensitive and predictive of longer term clinical outcomes. Additional research is necessary to relate tooth surface accumulation phenomena with oral soft tissue health.

Photography without film: low-cost digital cameras come of age in dermatology.

BACKGROUND: Photography is integral to the practice of dermatology. Digital imaging techniques have only recently been used to assess cutaneous disorders. Previously reported imaging systems have been both expensive and cumbersome. Consequently, they have failed to gain wide-spread acceptance. METHODS: We describe our experience using an inexpensive digital camera. Photographs taken with this portable digital camera (FotoMan) compare favorably to those obtained with conventional 35 mm cameras. RESULTS: This inexpensive digital camera provides photographs of acceptable quality for a variety of dermatologic applications. Images created with this system are available within minutes and are less expensive than traditional photographs. CONCLUSIONS: Digital imaging is a new and exciting development. The digital camera described is simple to operate and provides a useful alternative or adjunct to conventional photography.

Anticalculus efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride in a silica base: a twelve-week clinical study.

A randomized, two-compartment calculus clinical study of twelve-weeks duration was conducted among a group of calculus-forming subjects in the St. Louis area. The purpose of this parallel and double-blind clinical study was to compare the effect of a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer and 0.243% sodium fluoride in a silica base, to that of a placebo dentifrice, with regard to supragingival calculus formation. The study examiner, using the Volpe-Manhold Calculus Index, selected a panel of calculus-prone men and women who had completed a one-month placebo regimen. The Volpe-Manhold Calculus Index scores and the number of completely calculus-free sites were recorded. One-hundred and fifteen subjects were entered into the study. After an oral soft and hard tissue examination, the subjects were given a complete oral prophylaxis and randomly assigned to use either the placebo or test dentifrice for a 12-week home-use period. They were prohibited from using any other means of oral hygiene during the study. After completing 12 weeks of twice-daily brushing at home using their assigned toothpaste and a standard soft-bristled toothbrush, subjects were again assessed for supragingival calculus deposits and calculus-free sites. The dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer and 0.243% sodium fluoride in a silica base, inhibited supragingival calculus formation by 54.4%, as compared to a 0.243% sodium fluoride silica-based placebo dentifrice. The mean Volpe-Manhold Calculus Index scores were compared statistically and the difference indicated statistical significance at probability of 0.01 by means of an analysis of covariance (ANCOVA). The number of calculus-free sites, a second parameter of efficacy, also was compared and demonstrated an absolute difference of 32.6% in favor of the group using the dentifrice containing potassium nitrate, soluble pyrophosphate and PVM/MA copolymer compared to a placebo dentifrice (37.8% vs 5.2%, respectively). An analysis of covariance indicated that this improvement showed statistical significance at a probability of 0.01.

Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study.

The effect on dentinal hypersensitivity from the use of a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer, and 0.243% sodium fluoride in a silica base over a twelve-week period was compared to a matching placebo dentifrice without potassium nitrate. A total of sixty-seven subjects were entered into the study, and stratified into two balanced groups according to their baseline mean thermal (threshold) temperature (Thermodontic Stimulator) and baseline mean tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the potassium nitrate/copolymer/pyrophosphate dentifrice or the placebo dentifrice. The two groups were well balanced with regard to their mean baseline thermal and tactile sensitivity scores, sex and age. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations, which included tactile sensitivity, threshold thermal sensitivity, pain thermal sensitivity, air blast, and a visual analog scale were conducted at baseline, six weeks, and twelve weeks. All examinations were conducted by the same dental examiner. After six weeks' use of their assigned products, those subjects in the potassium nitrate/copolymer/pyrophosphate dentifrice group demonstrated statistically significant improvements (p < 0.01), as compared to the placebo dentifrice, in the following parameters: 1) tactile; 2) thermal (threshold and pain); and 3) air blast. After twelve weeks' use of their assigned products, those subjects in the potassium nitrate/copolymer/pyrophosphate dentifrice group again demonstrated statistically significant improvements (p < 0.01), in tactile, thermal (threshold and pain) and air blast sensitivity, as compared to the placebo dentifrice. It was concluded from this study that a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer, and 0.243% sodium fluoride in a silica base is a clinically effective treatment for reducing dentinal hypersensitivity.

The effect of a new experimental prebrushing dental rinse on plaque removal.

A randomized, double-blind, placebo-controlled study evaluated the effectiveness of a new and improved prebrushing dental rinse, Advanced Formula Plax, in reducing supragingival plaque. Following a 4-week pretest phase, the oral soft tissue, stain, gingivitis, and pre- and postbrushing plaque scores were evaluated for 153 subjects at baseline, 6, 12, 18, and 26 weeks. Patients were randomly assigned to receive either the active prebrushing dental rinse or a matching placebo that lacked the key ingredients responsible for the surfactant action of the active rinse. Compared with placebo, use of the active prebrushing rinse was associated with a significant reduction from baseline in postbrushing plaque scores at 12, 18, and 26 weeks on smooth surfaces, and with a significant reduction in postbrushing plaque scores on all surfaces at weeks 18 and 26. No significant difference was noted between the two treatment groups in gingivitis scores and stain indices. No product-related adverse experiences were noted. The results indicate that use of the new and improved prebrushing dental rinse represents a beneficial adjunct to toothbrushing and improved oral hygiene.