William DeVizio - Academia.edu (original) (raw)

Papers by William DeVizio

European Journal of Dentistry, 2017

Objectives:Air polishing with sodium bicarbonate powders with a grain size of 40 μm is recommende... more Objectives:Air polishing with sodium bicarbonate powders with a grain size of 40 μm is recommended for patient comfort. However, the efficacy of small grain size on stain removal has not been adequately studied. This study aimed to compare the stain removal efficacy of sodium bicarbonatepowders with grain sizes of 65 and 40 μm and to evaluate patient acceptance and operator opinion after using both air polishing powders. Materials and Methods: A double-blind, randomized, split-mouth study was conducted with 35 participants with moderate to heavy dental staining on both sides of the upper teeth. Removal of dental stains on the index teeth was performed using sodium bicarbonate powders with a grain size of either 65 or 40 μm. The time taken to completely remove all dental stains was recorded. After treatment, a questionnaire was used to evaluate patient acceptance and the operator's opinion.Results: The average time for the removal of all stains by powder was 4.5 ± 3.6 min with a ...

Open Journal of Stomatology, 2013

Aim: Oral malodor (halitosis) is a widespread condition caused by oral bacteria, particularly sul... more Aim: Oral malodor (halitosis) is a widespread condition caused by oral bacteria, particularly sulfur compound-producing species. This study assessed the effect of a triclosan/copolymer-containing dentifrice and a novel toothbrush with attached tongue cleaner on oral malodor and on the bacteria colonizing the dorsal surface of the tongue. Materials and Methods: 14 adult subjects with oral malodor defined as organoleptic scores ≥ 3 (scale 0-5) and mouth air sulfur levels ≥ 250 ppb participated in this study. Subjects were examined at baseline and after 28 days use of the triclosan dentifrice and toothbrush/tongue cleaner for: 1) organoleptic assessment; 2) mouth air sulfur levels; 3) tongue coating; and, 4) dorsal tongue surface microorganisms. Total bacterial numbers were assayed by microscopy. Dot-blot hybridization was used to assess a panel of 20 oral bacteria. Results: After 28 days, all subjects had significantly reduced organoleptic scores and mouth air sulfur levels compared to baseline (p < 0.0001). There was >70% reduction in microbial numbers (p < 0.001) on the dorsal tongue and significant reductions in Enterococcus faecalis (p < 0.003), Neisseria sp. (p < 0.008), Peptostreptococcus micros (p < 0.0007), Prevotella melaninogenica (p < 0.02), Porphyromonas gingivalis (p < 0.0001), Solobacterium moorei (p < 0.04), and Streptococci sp. (p < 0.03). Conclusions: Oral malodor was successfully treated in all subjects following 28 days use of the triclosan/copolymer-containing dentifrice and toothbrush with a tongue cleaner as determined by significant reductions in clinical measures of halitosis and a corresponding reduction in microbiological measures including sulfur compound-producing oral bacteria.

The Journal of clinical dentistry, 2008

Journal of Evidence Based Dental Practice, 2004

There are often many misconceptions about direct-to-consumer advertising both among the public an... more There are often many misconceptions about direct-to-consumer advertising both among the public and among dental professionals. To understand the way in which advertising claims are supported, it is important to differentiate between sound scientific evidence per se and the process of evidence-based decision making. This paper reviews the use of evidence in preparing and supporting advertising claims and provides an overview of the various guidelines and oversights that help maintain the quality of the scientific evidence used to demonstrate product safety and effectiveness. Direct-to-consumer advertising is an important subject and one about which there are often many misconceptions among the public and among dental professionals. Direct-to-consumer advertising can involve prescription as well as over-the-counter (OTC) products. The focus of this article will be on OTC products, though a good portion of the comments can be applicable to prescription products as well. In addition, it will be applicable to the entire gamut of advertising venues, including TV, magazines and newspapers, billboards, and the patient-oriented pamphlets found in dentists' offices. My perspective, therefore, will be from that of a large consumer products company, since these are the companies that run the vast majority of dental consumer product ads on TV and in print media. The primary themes of this paper are the following: Responsible companies base their product claims on sound studies, conducted in accordance with established, generally accepted guidelines and criteria. In addition to internal regulatory and legal controls, the industry is regulated by governmental agencies and, in some cases, voluntarily participates in programs that evaluate its products and their claims based on established criteria. Because multinational consumer products companies must establish and maintain credibility if they are to be successful in the long term, it is essential that their claims be based on sound evidence. This is especially true given the competitive nature of the consumer products market; if a company fails to base its claims on sound data, there is a strong possibility that a competitor will do the work to demonstrate the inaccuracy of the claims and use the data for comparative advertising and/or advertising challenges. In considering the manner in which advertising is evidence based, it is important to differentiate between sound evidence per se and the process of evidence-based decision making. Evidence-based practice uses an assessment of the available evidence, including the published literature, usually in the form of systematic reviews, to establish or confirm the effectiveness and utility of a given procedure or intervention. The objective is to provide a resource that will enable clinicians to use the "current best evidence" in making decisions affecting patient care. 1 The role of evidence in consumer product advertising is somewhat different; for this purpose, its role is to establish and document the safety and effectiveness of a particular product, rather than to establish or confirm the value of a particular intervention. Usually, the need for the product will have already been established before embarking on a development program because there is no point in producing a product for which there may be little demand. Therefore, for example, industry will conduct studies to provide evidence to establish the effectiveness of a new fluoride dentifrice formulation but will not have a need to conduct systematic reviews

Objective: Evaluate the efficacy of 0.8% arginine, potassium nitrate and sodium fluoride mouthwas... more Objective: Evaluate the efficacy of 0.8% arginine, potassium nitrate and sodium fluoride mouthwashes on dentine hypersensitivity reduction. Methods: Six week randomized, double blinded, two cell, parallel single centre clinical study in the Dominican Republic; subjects were randomized into three treatment groups: mouthwash containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride in an alcohol-free base (arginine); mouthwash containing 2.4% potassium nitrate and 0.022% sodium fluoride (potassium nitrate); a control mouthwash containing 0.05% sodium fluoride (negative control). Tactile and air-blast dentine hypersensitivity assessments were conducted at baseline, thirty minutes post rinsing and two, four, and six weeks of twice-daily product use. For treatment group comparisons, ANCOVA and post hoc Tukey’s pair-wise comparisons (a = 0.05) were done. Results: Seventy-five subjects were enrolled; 69 subjects completed the study. There were no differences aft...

The Journal of clinical dentistry, 2004

OBJECTIVE The objective of this six-week, examiner-blind clinical study was to assess the tooth w... more OBJECTIVE The objective of this six-week, examiner-blind clinical study was to assess the tooth whitening and extrinsic tooth stain removal efficacy of a new dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base (Test Dentifrice), relative to that of commercially available hexametaphosphate-containing whitening dentifrice (Positive Control Dentifrice). METHODOLOGY Following a baseline oral soft tissue examination and scoring of extrinsic tooth stain and tooth shade, qualifying adult male and female subjects from the Harrisburg, Pennsylvania area were randomized into either the Test or Positive Control Dentifrice group. The two groups were balanced for gender, extrinsic tooth stain, and tooth shade scores. All subjects were provided their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for two minutes twice daily (morning and evening) using o...

The Journal of clinical dentistry, 2011

The objective of the study was to compare the clinical efficacy in reducing dentin hypersensitivi... more The objective of the study was to compare the clinical efficacy in reducing dentin hypersensitivity of a test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride (NaF) in a silica base, to a positive control toothpaste containing 8.0% arginine and 1450 ppm fluoride as sodium monofluorophosphate (MFP) in a calcium carbonate base, and a negative control toothpaste containing 1100 ppm fluoride as NaF in a silica base. Subjects identified with two hypersensitive teeth using the tactile (Yeaple Probe) and air blast (Schiff's Scale) hypersensitivity methods were assigned to their treatment group. There were 50 subjects per group. Subjects then self-applied the assigned toothpaste to their hypersensitive teeth using a fingertip, then brushed their teeth at home using the same toothpaste twice daily for seven days. Dentin hypersensitivity and oral tissues were evaluated at baseline, immediately after the single application, and after seven days. A chi-squ...

American journal of dentistry, 2011

To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.2... more To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica in controlling established dental plaque and gingivitis. Qualifying adult male and female subjects from the West Palm Beach, Florida area were randomly assigned into one of two treatment groups: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica (Test Dentifrice); and (2) a dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). All subjects received an oral soft and hard tissue examination, baseline plaque and gingivitis were assessed, and subjects were dispensed their assigned dentifrice product along with a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for plaque and gingivitis, and oral s...

Compendium of continuing education in dentistry (Jamesburg, N.J. : 1995), 2009

The objective of this monadic clinical study was to evaluate the reduction in tooth sensitivity a... more The objective of this monadic clinical study was to evaluate the reduction in tooth sensitivity among patients who used the Colgate 360 degrees Sensitive toothbrush during an 8-week period. Adult men and women from the northern New Jersey area were required to present two teeth that exhibited sensitivity both to tactile stimulation using the Yeaple Probe and to thermal stimulation using an air blast delivered by a standard dental-unit syringe. After examination of the oral soft and hard tissues, qualifying patients were provided with a Colgate 360 degrees Sensitive toothbrush and a supply of a commercially available, nonsensitive fluoride toothpaste, and instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the toothbrush and dentifrice provided. No other oral hygiene practices were permitted during the course of the study. After 4 weeks and again after 8 weeks of product use, patients returned to the dental clinic for follow-up examinations of ...

The Journal of clinical dentistry, 2008

To assess the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/malei... more To assess the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste-Test Dentifrice) for controlling established supragingival plaque and gingivitis, relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste-Control Dentifrice). Following a baseline examination for supragingival plaque and gingivitis, qualifying adult male and female subjects from the Barcelona, Spain area were randomized into two treatment groups. Subjects were given a complete oral prophylaxis and instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were repeated after three months and six months of product use. Ninety-four (94) subjects complied with t...

American journal of dentistry, 2007

To evaluate the desensitizing capabilities of a new toothpaste containing 5.5% potassium citrate ... more To evaluate the desensitizing capabilities of a new toothpaste containing 5.5% potassium citrate (Colgate Sensitive Multi Protection Toothpaste) to another toothpaste containing 3.75% potassium chloride (Sensodyne Total Care F Toothpaste). A 4-week clinical study was conducted in 75 subjects at the University of Rome, at Tor Vergata, in Rome, Italy, using a double blind, stratified, two treatment design. Tactile sensitivity as well as air blast sensitivity assessment was used to compare the efficacy of the two products. There was no statistically significant difference in tactile sensitivity scores and air blast sensitivity scores between the tested toothpastes at baseline, 2 weeks and 4 weeks. Both toothpastes provided statistically significant improvement in tactile sensitivity scores and air blast sensitivity scores after 2 weeks of use and 4 weeks of use as compared to baseline scores.

The Journal of clinical dentistry, 2006

The objective of this examiner-blind clinical study was to investigate the efficacy of three oral... more The objective of this examiner-blind clinical study was to investigate the efficacy of three oral hygiene regimens for the control of gingivitis and supragingival plaque. Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the San Francisco, California area were stratified into three treatment groups, which were balanced for plaque. The groups were then randomly assigned to one of three oral hygiene regimens: 1) twice-daily tooth brushing with Colgate Total Toothpaste, accompanied by once-daily flossing after brushing; 2) twice-daily tooth brushing with Colgate Total Toothpaste without flossing; and 3) twice-daily tooth brushing with a sodium fluoride toothpaste, accompanied by once-daily flossing after brushing. All subjects were given a complete oral prophylaxis, and dispensed their assigned treatment product(s), along with a soft-bristled adult toothbrush for home use. All dentifrice products were supplied in th...

American journal of dentistry, 2004

To evaluate the safety and efficacy of a new manual toothbrush by comparing plaque removal and gi... more To evaluate the safety and efficacy of a new manual toothbrush by comparing plaque removal and gingivitis reduction after 4 weeks of use. This monadic clinical study included 46 subjects from the Northern New Jersey area who reported to the clinical facility for a baseline plaque and gingivitis examination after having refrained from all oral hygiene procedures and chewing gum for 8 hours, and from eating, drinking, or smoking for 4 hours. The population was comprised of healthy adult male and female subjects aged 27-68 years. Subjects were instructed to brush their teeth for 1 minute, twice a day with their assigned toothbrush and a commercially-available fluoride toothpaste (Colgate Cavity Protection Great Regular Flavor). After 4 weeks of use, subjects returned to the clinical facility for a final gingivitis and plaque examination. All 46 subjects complied with the protocol and completed the 4-week clinical study. The results of the study indicated that the new manual toothbrush ...

Compendium of continuing education in dentistry (Jamesburg, N.J. : 1995), 1997

The objective of this 6-month, double-blind clinical study, conducted following the American Dent... more The objective of this 6-month, double-blind clinical study, conducted following the American Dental Association guidelines, was to investigate the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice for the control of supragingival dental plaque and gingivitis. This dentifrice contains 0.454% stannous fluoride, stannous chloride, polyphosphate, and citrate in a silica base. At the 3- and 6-month study examinations, the COSF dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group. At the 6-month examination, the magnitude of these percent reductions exceeded 20% for all 4 parameters measured. Thus, the results of this study support the conclusion that the COSF dentifrice is efficacious for the control of supragingival plaque and gingivitis.

The Journal of clinical dentistry, 2003

This single-use, examiner-blind clinical study evaluated the efficacy of a newly introduced batte... more This single-use, examiner-blind clinical study evaluated the efficacy of a newly introduced battery-powered toothbrush (Colgate Motion Toothbrush) relative to a manual toothbrush (Oral-B CrossAction toothbrush) for the removal of supragingival plaque. This study assessed plaque removal via the comparison of pre- and post-brushing plaque levels. A total of 126 adult male and female subjects from the northern New Jersey area reported to the clinical facility for a baseline (pre-brushing) plaque examination after having refrained from all oral hygiene procedures and chewing gum for 24 hours, and from eating, drinking or smoking for four hours. Subjects were entered into the study and stratified into two balanced groups based on their baseline plaque scores. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available dentifrice, after which they were once again evaluated for supragingival plaque (post-brushin...

The Journal of clinical dentistry, 2003

The objective of this randomized, double-blind, parallel-group clinical study was to compare the ... more The objective of this randomized, double-blind, parallel-group clinical study was to compare the tooth whitening efficacy of two tooth whitening gel products--Colgate Simply White Night Clear Whitening Gel containing either 25% carbamide peroxide, or 8.7% hydrogen peroxide--when used once daily at night. Following a baseline tooth shade evaluation using the Vita Shade Guide, qualifying adult male and female subjects from the Central New Jersey area were randomized into two treatment groups, which were balanced for baseline Vita Shade Guide scores, gender and age. The treatment groups were: 1) a tooth whitening gel containing 25% carbamide peroxide; or 2) a tooth whitening gel containing 8.7% hydrogen peroxide. All subjects were given a commercially available, non-whitening dentifrice and a soft-bristled toothbrush at the beginning of the study. In addition, they were also given one of the two tooth whitening gel products. All subjects were instructed to brush their teeth for one min...

American journal of dentistry, 2010

To compare, with a double-blind, randomized, parallel-design clinical study, the hypersensitivity... more To compare, with a double-blind, randomized, parallel-design clinical study, the hypersensitivity efficacy of a new Pro-Argin formula dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride to a previously validated Pro-Argin formula dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride, and to a control toothpaste containing calcium carbonate and 1450 ppm fluoride, instantly after a single direct topical self-application using a fingertip, and after subsequent brushing for 3 days. Qualifying subjects from the Chengdu, China area who presented two hypersensitive teeth with a tactile score of 10 to 50 grams, and an air blast score of 2 or 3, participated in this study. The first phase of the study consisted of a single topical application of the assigned product directly onto the hypersensitive surface of each of the two hypersensitive teeth. Study subjects applied a pea-size amount of their toothpaste onto the hypers...

The Journal of clinical dentistry, 2011

The purpose of this clinical study was to evaluate the efficacy in reducing dental plaque regrowt... more The purpose of this clinical study was to evaluate the efficacy in reducing dental plaque regrowth of two mouthwashes containing 0.075% cetylpyridinium chloride (CPC), one with 6% alcohol and one alcohol-free, as compared to a negative control mouthwash without CPC, using the Modified Gingival Margin Plaque Index (MGMPI). The study was a double-blind, randomized, three-way crossover, controlled design. Following a washout period, subjects reported to the dental clinic where they were instructed to brush their teeth, used their assigned mouthwash, and were scored by the examining dentist for plaque using the MGMPI method. Subjects were instructed to refrain from all oral hygiene for the next 24 hours, except for rinsing with their assigned mouthwash 12 hours post-brushing. After this 24-hour period, subjects returned to the dental clinic and were once again scored for plaque. This sequence of washout followed by mouthwash use and plaque scoring was repeated until each subject had use...

American journal of dentistry, 2010

To present the results of an 8-week dentin hypersensitivity clinical study in which the efficacy ... more To present the results of an 8-week dentin hypersensitivity clinical study in which the efficacy of a new Pro-Argin formula toothpaste, with gentle whitening benefits, containing 8.0% arginine, a high cleaning calcium carbonate system, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a commercial Pro-Argin formula toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as MFP and a negative control toothpaste containing calcium carbonate and 1450 ppm fluoride as MFP. An 8-week clinical study, with 121 subjects, was conducted in Chengdu, Sichuan, China, using a double-blind, stratified, three-treatment design. Tactile and air blast sensitivity assessments were used to compare the efficacy of the three products. This clinical study demonstrated that the new Pro-Argin formula toothpaste provided a significant reduction in dentin hypersensitivity when used over a period of 8 weeks. The study also showed that the new toothpaste provi...

The Journal of clinical dentistry, 2009

The objective of this independent, double-blind, parallel, six-week clinical study was to assess ... more The objective of this independent, double-blind, parallel, six-week clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% cetylpyridinium chloride (CPC) for controlling established dental plaque and gingivitis relative to that of a control mouthrinse without CPC. Adult male and female subjects from the Maceió, Brazil area reported to the clinical facility, after having refrained from any oral hygiene procedures for 12 hours, and from eating, drinking, and smoking for four hours, for an assessment of the oral soft and hard tissues, and for a baseline gingivitis and dental plaque evaluation. Qualifying subjects were randomly assigned to one of the two treatment groups, and were provided with their assigned mouthrinse, and an adult soft-bristled toothbrush and toothpaste for home use. Over the six-week period of home use, during which there were no restrictions regarding diet or smoking habits, subjects were instructed to brush their teeth fo...

European Journal of Dentistry, 2017

Objectives:Air polishing with sodium bicarbonate powders with a grain size of 40 μm is recommende... more Objectives:Air polishing with sodium bicarbonate powders with a grain size of 40 μm is recommended for patient comfort. However, the efficacy of small grain size on stain removal has not been adequately studied. This study aimed to compare the stain removal efficacy of sodium bicarbonatepowders with grain sizes of 65 and 40 μm and to evaluate patient acceptance and operator opinion after using both air polishing powders. Materials and Methods: A double-blind, randomized, split-mouth study was conducted with 35 participants with moderate to heavy dental staining on both sides of the upper teeth. Removal of dental stains on the index teeth was performed using sodium bicarbonate powders with a grain size of either 65 or 40 μm. The time taken to completely remove all dental stains was recorded. After treatment, a questionnaire was used to evaluate patient acceptance and the operator's opinion.Results: The average time for the removal of all stains by powder was 4.5 ± 3.6 min with a ...

Open Journal of Stomatology, 2013

Aim: Oral malodor (halitosis) is a widespread condition caused by oral bacteria, particularly sul... more Aim: Oral malodor (halitosis) is a widespread condition caused by oral bacteria, particularly sulfur compound-producing species. This study assessed the effect of a triclosan/copolymer-containing dentifrice and a novel toothbrush with attached tongue cleaner on oral malodor and on the bacteria colonizing the dorsal surface of the tongue. Materials and Methods: 14 adult subjects with oral malodor defined as organoleptic scores ≥ 3 (scale 0-5) and mouth air sulfur levels ≥ 250 ppb participated in this study. Subjects were examined at baseline and after 28 days use of the triclosan dentifrice and toothbrush/tongue cleaner for: 1) organoleptic assessment; 2) mouth air sulfur levels; 3) tongue coating; and, 4) dorsal tongue surface microorganisms. Total bacterial numbers were assayed by microscopy. Dot-blot hybridization was used to assess a panel of 20 oral bacteria. Results: After 28 days, all subjects had significantly reduced organoleptic scores and mouth air sulfur levels compared to baseline (p < 0.0001). There was >70% reduction in microbial numbers (p < 0.001) on the dorsal tongue and significant reductions in Enterococcus faecalis (p < 0.003), Neisseria sp. (p < 0.008), Peptostreptococcus micros (p < 0.0007), Prevotella melaninogenica (p < 0.02), Porphyromonas gingivalis (p < 0.0001), Solobacterium moorei (p < 0.04), and Streptococci sp. (p < 0.03). Conclusions: Oral malodor was successfully treated in all subjects following 28 days use of the triclosan/copolymer-containing dentifrice and toothbrush with a tongue cleaner as determined by significant reductions in clinical measures of halitosis and a corresponding reduction in microbiological measures including sulfur compound-producing oral bacteria.

The Journal of clinical dentistry, 2008

Journal of Evidence Based Dental Practice, 2004

There are often many misconceptions about direct-to-consumer advertising both among the public an... more There are often many misconceptions about direct-to-consumer advertising both among the public and among dental professionals. To understand the way in which advertising claims are supported, it is important to differentiate between sound scientific evidence per se and the process of evidence-based decision making. This paper reviews the use of evidence in preparing and supporting advertising claims and provides an overview of the various guidelines and oversights that help maintain the quality of the scientific evidence used to demonstrate product safety and effectiveness. Direct-to-consumer advertising is an important subject and one about which there are often many misconceptions among the public and among dental professionals. Direct-to-consumer advertising can involve prescription as well as over-the-counter (OTC) products. The focus of this article will be on OTC products, though a good portion of the comments can be applicable to prescription products as well. In addition, it will be applicable to the entire gamut of advertising venues, including TV, magazines and newspapers, billboards, and the patient-oriented pamphlets found in dentists' offices. My perspective, therefore, will be from that of a large consumer products company, since these are the companies that run the vast majority of dental consumer product ads on TV and in print media. The primary themes of this paper are the following: Responsible companies base their product claims on sound studies, conducted in accordance with established, generally accepted guidelines and criteria. In addition to internal regulatory and legal controls, the industry is regulated by governmental agencies and, in some cases, voluntarily participates in programs that evaluate its products and their claims based on established criteria. Because multinational consumer products companies must establish and maintain credibility if they are to be successful in the long term, it is essential that their claims be based on sound evidence. This is especially true given the competitive nature of the consumer products market; if a company fails to base its claims on sound data, there is a strong possibility that a competitor will do the work to demonstrate the inaccuracy of the claims and use the data for comparative advertising and/or advertising challenges. In considering the manner in which advertising is evidence based, it is important to differentiate between sound evidence per se and the process of evidence-based decision making. Evidence-based practice uses an assessment of the available evidence, including the published literature, usually in the form of systematic reviews, to establish or confirm the effectiveness and utility of a given procedure or intervention. The objective is to provide a resource that will enable clinicians to use the "current best evidence" in making decisions affecting patient care. 1 The role of evidence in consumer product advertising is somewhat different; for this purpose, its role is to establish and document the safety and effectiveness of a particular product, rather than to establish or confirm the value of a particular intervention. Usually, the need for the product will have already been established before embarking on a development program because there is no point in producing a product for which there may be little demand. Therefore, for example, industry will conduct studies to provide evidence to establish the effectiveness of a new fluoride dentifrice formulation but will not have a need to conduct systematic reviews

Objective: Evaluate the efficacy of 0.8% arginine, potassium nitrate and sodium fluoride mouthwas... more Objective: Evaluate the efficacy of 0.8% arginine, potassium nitrate and sodium fluoride mouthwashes on dentine hypersensitivity reduction. Methods: Six week randomized, double blinded, two cell, parallel single centre clinical study in the Dominican Republic; subjects were randomized into three treatment groups: mouthwash containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride in an alcohol-free base (arginine); mouthwash containing 2.4% potassium nitrate and 0.022% sodium fluoride (potassium nitrate); a control mouthwash containing 0.05% sodium fluoride (negative control). Tactile and air-blast dentine hypersensitivity assessments were conducted at baseline, thirty minutes post rinsing and two, four, and six weeks of twice-daily product use. For treatment group comparisons, ANCOVA and post hoc Tukey’s pair-wise comparisons (a = 0.05) were done. Results: Seventy-five subjects were enrolled; 69 subjects completed the study. There were no differences aft...

The Journal of clinical dentistry, 2004

OBJECTIVE The objective of this six-week, examiner-blind clinical study was to assess the tooth w... more OBJECTIVE The objective of this six-week, examiner-blind clinical study was to assess the tooth whitening and extrinsic tooth stain removal efficacy of a new dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base (Test Dentifrice), relative to that of commercially available hexametaphosphate-containing whitening dentifrice (Positive Control Dentifrice). METHODOLOGY Following a baseline oral soft tissue examination and scoring of extrinsic tooth stain and tooth shade, qualifying adult male and female subjects from the Harrisburg, Pennsylvania area were randomized into either the Test or Positive Control Dentifrice group. The two groups were balanced for gender, extrinsic tooth stain, and tooth shade scores. All subjects were provided their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for two minutes twice daily (morning and evening) using o...

The Journal of clinical dentistry, 2011

The objective of the study was to compare the clinical efficacy in reducing dentin hypersensitivi... more The objective of the study was to compare the clinical efficacy in reducing dentin hypersensitivity of a test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride (NaF) in a silica base, to a positive control toothpaste containing 8.0% arginine and 1450 ppm fluoride as sodium monofluorophosphate (MFP) in a calcium carbonate base, and a negative control toothpaste containing 1100 ppm fluoride as NaF in a silica base. Subjects identified with two hypersensitive teeth using the tactile (Yeaple Probe) and air blast (Schiff's Scale) hypersensitivity methods were assigned to their treatment group. There were 50 subjects per group. Subjects then self-applied the assigned toothpaste to their hypersensitive teeth using a fingertip, then brushed their teeth at home using the same toothpaste twice daily for seven days. Dentin hypersensitivity and oral tissues were evaluated at baseline, immediately after the single application, and after seven days. A chi-squ...

American journal of dentistry, 2011

To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.2... more To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica in controlling established dental plaque and gingivitis. Qualifying adult male and female subjects from the West Palm Beach, Florida area were randomly assigned into one of two treatment groups: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica (Test Dentifrice); and (2) a dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). All subjects received an oral soft and hard tissue examination, baseline plaque and gingivitis were assessed, and subjects were dispensed their assigned dentifrice product along with a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for plaque and gingivitis, and oral s...

Compendium of continuing education in dentistry (Jamesburg, N.J. : 1995), 2009

The objective of this monadic clinical study was to evaluate the reduction in tooth sensitivity a... more The objective of this monadic clinical study was to evaluate the reduction in tooth sensitivity among patients who used the Colgate 360 degrees Sensitive toothbrush during an 8-week period. Adult men and women from the northern New Jersey area were required to present two teeth that exhibited sensitivity both to tactile stimulation using the Yeaple Probe and to thermal stimulation using an air blast delivered by a standard dental-unit syringe. After examination of the oral soft and hard tissues, qualifying patients were provided with a Colgate 360 degrees Sensitive toothbrush and a supply of a commercially available, nonsensitive fluoride toothpaste, and instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the toothbrush and dentifrice provided. No other oral hygiene practices were permitted during the course of the study. After 4 weeks and again after 8 weeks of product use, patients returned to the dental clinic for follow-up examinations of ...

The Journal of clinical dentistry, 2008

To assess the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/malei... more To assess the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste-Test Dentifrice) for controlling established supragingival plaque and gingivitis, relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste-Control Dentifrice). Following a baseline examination for supragingival plaque and gingivitis, qualifying adult male and female subjects from the Barcelona, Spain area were randomized into two treatment groups. Subjects were given a complete oral prophylaxis and instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were repeated after three months and six months of product use. Ninety-four (94) subjects complied with t...

American journal of dentistry, 2007

To evaluate the desensitizing capabilities of a new toothpaste containing 5.5% potassium citrate ... more To evaluate the desensitizing capabilities of a new toothpaste containing 5.5% potassium citrate (Colgate Sensitive Multi Protection Toothpaste) to another toothpaste containing 3.75% potassium chloride (Sensodyne Total Care F Toothpaste). A 4-week clinical study was conducted in 75 subjects at the University of Rome, at Tor Vergata, in Rome, Italy, using a double blind, stratified, two treatment design. Tactile sensitivity as well as air blast sensitivity assessment was used to compare the efficacy of the two products. There was no statistically significant difference in tactile sensitivity scores and air blast sensitivity scores between the tested toothpastes at baseline, 2 weeks and 4 weeks. Both toothpastes provided statistically significant improvement in tactile sensitivity scores and air blast sensitivity scores after 2 weeks of use and 4 weeks of use as compared to baseline scores.

The Journal of clinical dentistry, 2006

The objective of this examiner-blind clinical study was to investigate the efficacy of three oral... more The objective of this examiner-blind clinical study was to investigate the efficacy of three oral hygiene regimens for the control of gingivitis and supragingival plaque. Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the San Francisco, California area were stratified into three treatment groups, which were balanced for plaque. The groups were then randomly assigned to one of three oral hygiene regimens: 1) twice-daily tooth brushing with Colgate Total Toothpaste, accompanied by once-daily flossing after brushing; 2) twice-daily tooth brushing with Colgate Total Toothpaste without flossing; and 3) twice-daily tooth brushing with a sodium fluoride toothpaste, accompanied by once-daily flossing after brushing. All subjects were given a complete oral prophylaxis, and dispensed their assigned treatment product(s), along with a soft-bristled adult toothbrush for home use. All dentifrice products were supplied in th...

American journal of dentistry, 2004

To evaluate the safety and efficacy of a new manual toothbrush by comparing plaque removal and gi... more To evaluate the safety and efficacy of a new manual toothbrush by comparing plaque removal and gingivitis reduction after 4 weeks of use. This monadic clinical study included 46 subjects from the Northern New Jersey area who reported to the clinical facility for a baseline plaque and gingivitis examination after having refrained from all oral hygiene procedures and chewing gum for 8 hours, and from eating, drinking, or smoking for 4 hours. The population was comprised of healthy adult male and female subjects aged 27-68 years. Subjects were instructed to brush their teeth for 1 minute, twice a day with their assigned toothbrush and a commercially-available fluoride toothpaste (Colgate Cavity Protection Great Regular Flavor). After 4 weeks of use, subjects returned to the clinical facility for a final gingivitis and plaque examination. All 46 subjects complied with the protocol and completed the 4-week clinical study. The results of the study indicated that the new manual toothbrush ...

Compendium of continuing education in dentistry (Jamesburg, N.J. : 1995), 1997

The objective of this 6-month, double-blind clinical study, conducted following the American Dent... more The objective of this 6-month, double-blind clinical study, conducted following the American Dental Association guidelines, was to investigate the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice for the control of supragingival dental plaque and gingivitis. This dentifrice contains 0.454% stannous fluoride, stannous chloride, polyphosphate, and citrate in a silica base. At the 3- and 6-month study examinations, the COSF dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group. At the 6-month examination, the magnitude of these percent reductions exceeded 20% for all 4 parameters measured. Thus, the results of this study support the conclusion that the COSF dentifrice is efficacious for the control of supragingival plaque and gingivitis.

The Journal of clinical dentistry, 2003

This single-use, examiner-blind clinical study evaluated the efficacy of a newly introduced batte... more This single-use, examiner-blind clinical study evaluated the efficacy of a newly introduced battery-powered toothbrush (Colgate Motion Toothbrush) relative to a manual toothbrush (Oral-B CrossAction toothbrush) for the removal of supragingival plaque. This study assessed plaque removal via the comparison of pre- and post-brushing plaque levels. A total of 126 adult male and female subjects from the northern New Jersey area reported to the clinical facility for a baseline (pre-brushing) plaque examination after having refrained from all oral hygiene procedures and chewing gum for 24 hours, and from eating, drinking or smoking for four hours. Subjects were entered into the study and stratified into two balanced groups based on their baseline plaque scores. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available dentifrice, after which they were once again evaluated for supragingival plaque (post-brushin...

The Journal of clinical dentistry, 2003

The objective of this randomized, double-blind, parallel-group clinical study was to compare the ... more The objective of this randomized, double-blind, parallel-group clinical study was to compare the tooth whitening efficacy of two tooth whitening gel products--Colgate Simply White Night Clear Whitening Gel containing either 25% carbamide peroxide, or 8.7% hydrogen peroxide--when used once daily at night. Following a baseline tooth shade evaluation using the Vita Shade Guide, qualifying adult male and female subjects from the Central New Jersey area were randomized into two treatment groups, which were balanced for baseline Vita Shade Guide scores, gender and age. The treatment groups were: 1) a tooth whitening gel containing 25% carbamide peroxide; or 2) a tooth whitening gel containing 8.7% hydrogen peroxide. All subjects were given a commercially available, non-whitening dentifrice and a soft-bristled toothbrush at the beginning of the study. In addition, they were also given one of the two tooth whitening gel products. All subjects were instructed to brush their teeth for one min...

American journal of dentistry, 2010

To compare, with a double-blind, randomized, parallel-design clinical study, the hypersensitivity... more To compare, with a double-blind, randomized, parallel-design clinical study, the hypersensitivity efficacy of a new Pro-Argin formula dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride to a previously validated Pro-Argin formula dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride, and to a control toothpaste containing calcium carbonate and 1450 ppm fluoride, instantly after a single direct topical self-application using a fingertip, and after subsequent brushing for 3 days. Qualifying subjects from the Chengdu, China area who presented two hypersensitive teeth with a tactile score of 10 to 50 grams, and an air blast score of 2 or 3, participated in this study. The first phase of the study consisted of a single topical application of the assigned product directly onto the hypersensitive surface of each of the two hypersensitive teeth. Study subjects applied a pea-size amount of their toothpaste onto the hypers...

The Journal of clinical dentistry, 2011

The purpose of this clinical study was to evaluate the efficacy in reducing dental plaque regrowt... more The purpose of this clinical study was to evaluate the efficacy in reducing dental plaque regrowth of two mouthwashes containing 0.075% cetylpyridinium chloride (CPC), one with 6% alcohol and one alcohol-free, as compared to a negative control mouthwash without CPC, using the Modified Gingival Margin Plaque Index (MGMPI). The study was a double-blind, randomized, three-way crossover, controlled design. Following a washout period, subjects reported to the dental clinic where they were instructed to brush their teeth, used their assigned mouthwash, and were scored by the examining dentist for plaque using the MGMPI method. Subjects were instructed to refrain from all oral hygiene for the next 24 hours, except for rinsing with their assigned mouthwash 12 hours post-brushing. After this 24-hour period, subjects returned to the dental clinic and were once again scored for plaque. This sequence of washout followed by mouthwash use and plaque scoring was repeated until each subject had use...

American journal of dentistry, 2010

To present the results of an 8-week dentin hypersensitivity clinical study in which the efficacy ... more To present the results of an 8-week dentin hypersensitivity clinical study in which the efficacy of a new Pro-Argin formula toothpaste, with gentle whitening benefits, containing 8.0% arginine, a high cleaning calcium carbonate system, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a commercial Pro-Argin formula toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as MFP and a negative control toothpaste containing calcium carbonate and 1450 ppm fluoride as MFP. An 8-week clinical study, with 121 subjects, was conducted in Chengdu, Sichuan, China, using a double-blind, stratified, three-treatment design. Tactile and air blast sensitivity assessments were used to compare the efficacy of the three products. This clinical study demonstrated that the new Pro-Argin formula toothpaste provided a significant reduction in dentin hypersensitivity when used over a period of 8 weeks. The study also showed that the new toothpaste provi...

The Journal of clinical dentistry, 2009

The objective of this independent, double-blind, parallel, six-week clinical study was to assess ... more The objective of this independent, double-blind, parallel, six-week clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% cetylpyridinium chloride (CPC) for controlling established dental plaque and gingivitis relative to that of a control mouthrinse without CPC. Adult male and female subjects from the Maceió, Brazil area reported to the clinical facility, after having refrained from any oral hygiene procedures for 12 hours, and from eating, drinking, and smoking for four hours, for an assessment of the oral soft and hard tissues, and for a baseline gingivitis and dental plaque evaluation. Qualifying subjects were randomly assigned to one of the two treatment groups, and were provided with their assigned mouthrinse, and an adult soft-bristled toothbrush and toothpaste for home use. Over the six-week period of home use, during which there were no restrictions regarding diet or smoking habits, subjects were instructed to brush their teeth fo...