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Biomedical subjects

H M Proskin

Publications and source records attributed to H M Proskin.

At least 19 recordsLinked to original sources

A single dose of ranitidine 150 mg modulates oesophageal acid sensitivity in patients with functional heartburn.

BACKGROUND: The rapid onset and symptomatic response to histamine-2 receptor antagonists prior to the pharmacological effect on acid secretion suggests a different mechanism of action. AIM: To determine if ranitidine decreases oesophageal sensitivity to chemical and mechanical stimulation, potentially via oesophageal histamine receptors. METHODS: A total of 18 patients with functional heartburn received oral ranitidine 150 mg b.d. or placebo for 7 consecutive days in a double-blind randomized crossover design and underwent Barostat balloon distention and Bernstein acid infusion on study day 1 (90 min postdose) and study day 7. First sensation and pain were recorded and pain severity was rated on a 5-point Likert scale and a 100 mm visual analogue scale. Least square mean values were generated and one-tailed t-tests were performed. RESULTS: After a single dose of ranitidine 150 mg, time to pain with oesophageal acid infusion was increased by 29% (P < 0.05) and visual analogue scale and Likert scores were decreased by 20% (P < 0.06) and 23% (P < 0.02), respectively compared with placebo. After 1 week of ranitidine, positive alterations in sensory parameters persisted. Balloon distention sensory parameters were not altered by ranitidine. CONCLUSIONS: Ranitidine significantly decreased oesophageal sensitivity to acid. Failure of ranitidine to improve balloon sensory parameters supports existence of multiple sensory pathways in the oesophagus.

Administration, Oral↗

Clinical outcomes for Early Childhood Caries (ECC): the influence of health locus of control.

AIM: To assess the relationship between clinical outcomes for children treated for ECC and health locus of control. STUDY DESIGN AND METHODS: The study cohort consisted of 79 children (42 males, 37 females) treated for ECC; age range was 2.3-7.3 years (mean 4.2 years) at the time of entry into the study. A questionnaire [developed by DeVellis et al., 1993] was administered to each child's parent(s) on the day of dental surgery. This questionnaire examined the expectation that healthcare outcomes in children are influenced by one of the following loci of control: Professional, Parent, Child, Media, Fate and Divine. The cohort was evaluated for new caries lesions at 6 months post dental surgery. Relapse was defined as the presence of new smooth surface caries lesions. STATISTICS: For each locus, the scores for the Relapse versus Non-relapse groups (returning patients) and the scores for the returning versus non-returning patients were compared using t-tests. RESULTS: 57 children (72%) returned for follow-up and 21 of these 57 (37%) relapsed. No statistically significant difference for Relapse versus Non-relapse groups was indicated with respect to the scores for any locus parameter (p values ranged from 0.35 to 0.95). Returning parents (N=57) versus non- returning parents (N=22) exhibited statistically significant differences with respect to the Parent, Divine and Fate loci. Returning parents exhibited higher scores on the Parent locus (p=0.0392) and lower scores on the Fate (p=0.0024) and Divine (p=0.0031) loci. CONCLUSION: 1). The relapse rate (37%) was high and rapid for children treated for ECC; 2). no meaningful difference existed between the Relapse versus Non-relapse groups with respect to each health locus of control parameter; 3). parents who returned for follow-up care appeared to have an internal health locus of control while those who did not return had an external locus.

Child↗

Clinical outcomes for Early Childhood Caries (ECC): the influence of salivary mutans streptococci levels.

AIM: To assess the relationship between clinical outcomes for children treated for Early Childhood Caries (ECC) and salivary mutans streptococci (MS) levels. STUDY DESIGN AND METHODS: The study cohort consisted of 79 children (42 males, 37 females) treated for ECC, aged from 2.3 to 7.3 years at time of entry. Whole non-stimulated saliva samples were obtained from each subject prior to dental surgery and at 6 mths post dental surgery, by saturating a cotton swab in the saliva pooled in the floor of the mouth. Samples were placed into PBS on ice and processed within 2 hours. Samples were sonicated, serially diluted and plated onto MSB and SBA agar plates, then incubated 48 hours anaerobically; SBA plates were incubated an additional 24 hours aerobically. The MS level in each sample was expressed as a percentage of the total cultivable flora. The cohort was evaluated for new caries lesions at 6 months post dental surgery. Relapse was defined as the presence of new smooth surface caries lesions. STATISTICS: Comparisons between Relapse (R) and Non-Relapse (NR) groups with respect to mutans streptococci levels were performed using Wilcoxon tests. Within group comparisons were performed using Wilcoxon signed-rank tests. RESULTS: 57 children (72%) returned for the 6 months examination and 21 of these subjects (37%) relapsed. No statistically significant difference in median salivary MS levels existed between the R (0.20%) and NR (0.033%) groups at baseline (p=0.647) or at 6 months post dental surgery (R=0.03%; NR=0.01%; p=0.273). A statistically significant difference between baseline and 6 months post dental surgery was noted in the median salivary MS level within the R group (p=0.0007) and within the NR group (P<0.0001). CONCLUSIONS: The relapse rate (37%) was high and rapid for children treated for ECC. Dental surgery resulted in a statistically significant reduction in salivary MS reservoirs for children treated for ECC. However, this did not translate into acceptable clinical outcomes.

Child↗

Clinical effectiveness of a new antacid chewing gum on heartburn and oesophageal pH control.

BACKGROUND: Oesophageal acid neutralization with antacids depends on the duration of oesophageal antacid exposure and acid neutralizing capacity. A gum that releases antacid as it is chewed could take advantage of both mechanisms to enhance heartburn relief. METHODS: Twenty-four subjects were crossed over to four regimens: placebo, chewable antacid tablets (1000 mg CaCO3), lower dose gum (600 mg CaCO3) and higher dose gum (900 mg CaCO3). A dual pH probe was placed, subjects ate a standardized provocative meal and self-dosed once as needed. Symptoms were recorded every 15 min using visual analogue and Likert scales. RESULTS SYMPTOMS: Both gums decreased heartburn compared to placebo for 120 min. Higher dose gum decreased heartburn more than chewable antacids up to 120 min post-dose. pH: Active chewable antacid and gums immediately increased oesophageal pH, with significant improvement 15-30 min post-dose. SUMMARY: (i) both gums promptly decreased heartburn and elevated oesophageal pH; (ii) both gums provided sustained relief for 120 min; (iii) antacid gums provided faster and more prolonged symptom relief and pH control than chewable antacids. CONCLUSIONS: Calcium carbonate gum effectively neutralizes oesophageal acidity and relieves symptoms following a meal, and is superior to chewable antacids in terms of the duration of heartburn relief.

Adolescent↗

Effect of after-meal sucrose-free gum-chewing on clinical caries.

Previous in situ and in vitro studies have demonstrated that the chewing of sucrose-free gum after eating reduces the development of dental caries. To investigate the extrapolation of these findings to the clinical setting, we conducted a two-year study on 547 schoolchildren in Budapest, Hungary. Subjects in the "Gum" group were instructed to chew one stick of a commercially available sorbitol-sweetened chewing gum for 20 minutes after meals, three times daily. The "Control" group was not provided with chewing gum. After two years, the "Gum" group exhibited a 38.7% reduction in incremental caries, excluding white spots, compared with the "Control" group. Including white spots, a corresponding 33.1% reduction was indicated. These results clearly suggest that even in a moderate caries population practicing normal oral hygiene, including the use of fluoride dentifrices, an after-meal gum-chewing regimen can significantly reduce the rate of caries development.

Adolescent↗

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in the United States of America.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 5-17 yr-old children from the Central and South areas of Florida and from the Lares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand five hundred six (2,506) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 0.69 for the Test Dentifrice group and 0.81 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 1.25 for the Test Dentifrice group, and 1.46 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 14.38% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

Adolescent↗

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in Brazil.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 6-10 yr-old children from the metropolitan area of Maceio, Alagoas, Brazil. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. One calibrated examiner performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand four hundred thirty-two (2,432) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 3.84 for the Test Dentifrice group, and 4.06 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 2.02 for the Test Dentifrice group and 2.12 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 4.30 for the Test Dentifrice group, and 4.83 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 10.97% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

Brazil↗

The comparative anticaries efficacy of a dentifrice containing 0.3% triclosan and 2.0% copolymer in a 0.243% sodium fluoride/silica base and a dentifrice containing 0.243% sodium fluoride/silica base: a two-year coronal caries clinical trial on adults in Israel.

The purpose of this two-year clinical study was to provide a comparison of the anticaries efficacy associated with two commercially available, American Dental Association-accepted dentifrices: Colgate Total Toothpaste, which contains 0.3% triclosan and 2% copolymer in a 0.243% sodium fluoride/silica base; and Crest Cavity Fighting Toothpaste with Fluoristat, which contains 0.243% sodium fluoride in a silica base. The study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. The study employed a double-blind parallel-group design, and involved adults living in communities throughout Israel. Qualifying subjects were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all of the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to ensure compliance with the study. Post-baseline examinations were performed after one year of product use, and again after two years of product use. Three-thousand, three-hundred and ninety-two (3,392) subjects completed this two-year study. For these subjects, the mean caries scores (DFS, decayed or filled surfaces) at baseline were 21.96 for the Colgate Total Toothpaste group, and 21.49 for the Crest Cavity Fighting Toothpaste with Fluoristat group. For caries increment after one year, the respective means were 1.37 for the Colgate Total Toothpaste group, and 1.56 for the Crest Cavity Fighting Toothpaste with Fluoristat group. After two years, the mean caries increments were 1.46 for the Colgate Total Toothpaste group, and 1.75 for the Crest Cavity Fighting Toothpaste with Fluoristat group. No statically significant difference was indicated between the treatment groups at baseline. However, for both the one-year and two-year increments, there was a statistically significant difference between treatment groups. Relative to the Crest Cavity Fighting Toothpaste with Fluoristat group, the Colgate Total Toothpaste group presented a 12.2% reduction in caries increment scores at one year, and a 16.6% reduction in caries increment scores at two years. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that Colgate Total Toothpaste provides a superior level of coronal anticaries efficacy compared to Crest Cavity Fighting Toothpaste with Fluoristat.

Adult↗

The comparative plaque removal efficacy of two advanced manual toothbrush designs in two independent clinical studies.

Two independent studies were conducted to evaluate and compare the clinical performance of two commercially available manual toothbrushes (Colgate Total Professional and the Oral-B Cross Action). Study I was a short-term, examiner-blind crossover clinical trial (N = 30) designed to measure the removal of 24-hour plaque build-up. All subjects refrained from brushing for 24 hours and were screened for dental plaque on the facial and lingual surfaces of all natural teeth using the Rustogi Modified Navy Plaque Index. Patients then received one of the two study toothbrushes and brushed their teeth for a timed one minute. They were then re-assessed for plaque. The data showed that the Colgate Total Professional toothbrush performed better than the Oral-B Cross Action toothbrush in reducing whole-mouth plaque scores (p < 0.001). Study II was a definitive six-week, single-blind clinical trial (N = 55), conducted in harmony with American Dental Association guidelines, to assess the ability of the two toothbrushes to reduce supragingival plaque and gingivitis. In this study, the subjects were stratified into two balanced groups based on their baseline plaque and gingivitis scores. Subjects were then instructed to continue with their normal brushing technique twice daily for one minute with their assigned toothbrush and a commercially available dentifrice. Examinations for plaque (Rustogi Modified Navy Plaque Index), and gingivitis (Loe-Silness Gingival Index) were conducted by the same examiner at baseline, after three weeks, and again after six weeks. The data from this long-term clinical trial showed that the Colgate Total Professional toothbrush exhibited statistically significantly lower plaque and gingivitis scores than did the Oral-B Cross Action toothbrush. The magnitudes of these differences were 29.5% for plaque and 31.1% for gingivitis. These reductions are adequate to support the claim that the Colgate Total Professional toothbrush provides clinically superior control of supragingival plaque and gingivitis, when studied in accordance with the criteria provided by the 1999 Guidelines of the American Dental Association for determining superiority.

Adolescent↗

A graphic display for the presentation of site-wise odds ratios for score transitions to augment the traditional findings from clinical studies employing dental indexes.

Many of the parameters used in clinical dental research involve the assessment of a condition at each of a number of sites within the mouth. Traditionally, such measurements are averaged over all sites within the mouth (or over all sites of a specified type) for each study participant before statistical analysis. However, a consideration of the original, site-wise scores may provide some additional insights into the performance of therapeutic modalities that might not be made evident through an application of the traditional, means-based approach. A method based on the calculation of site-wise odds ratios of certain types of baseline-to-final examination score transitions was applied to the modified gingival index data from two clinical studies performed to investigate the effect of the daily chewing of a commercially available chewing gum relative to a mint control. A graphical display of these site-specific findings was prepared, which indicated that the chewing gum regimen tended to be associated with a higher frequency of occurrence of favorable score transitions than was the mint control at several measurement sites throughout the mouth.

Chewing Gum↗

An evaluation of sodium bicarbonate chewing gum in reducing dental plaque and gingivitis in conjunction with regular toothbrushing.

The purpose of the present study was to determine the ability of a chewing gum containing 5% sodium bicarbonate to remove dental plaque and reduce gingivitis when used as a supplement to daily toothbrushing. The study group consisted of 88 adults with moderate gingivitis. Participants were divided into 4 groups and instructed to chew the study gum 0 (control), 1, 2, or 3 times daily for 1 month in addition to regular daily toothbrushing. Chewing sodium bicarbonate-containing gum significantly (P < .05) reduced plaque after 1 week, with progressively greater reductions occurring after 2 and 4 weeks of gum chewing. No correlation was observed between plaque reduction and the number of times per day that the gum was chewed. By week 4, plaque reduction of approximately 16% was achieved in all groups using the gum as compared with the control group. Reductions in gingivitis were observed in all participants who chewed the gum, and these reductions achieved statistical significance by week 4. Slightly greater improvements in gingivitis were achieved in participants who chewed the gum 2 or 3 times daily as compared with the control group and those who chewed the gum once daily. No adverse effects on the oral tissues were observed in any of the participants for the duration of the study. In conclusion, regular use of a chewing gum containing 5% sodium bicarbonate appears safe and effective for the removal of dental plaque and reduction of gingivitis when used in conjunction with daily toothbrushing.

Adult↗

The effectiveness of 10% chlorhexidine varnish treatment on dental caries incidence in adults with dry mouth.

OBJECTIVES: This study compared a 10% chlorhexidine varnish treatment with placebo and sham treatments for preventing dental caries in adult patients with xerostomia (dry mouth). DESIGN: The study was a multicentred, randomized, parallel group, double blind, placebo-controlled clinical trial. SETTING: All examinations and procedures were performed at Tuft's University, Boston, MA, the University of British Columbia, Vancouver, BC or the University of Western Ontario, London, ON. SUBJECTS: Subjects were adults with recent or current dental caries experience, high salivary levels of cariogenic microorganisms and low salivary flow rates. RESULTS: 236 subjects completed at least one post-treatment examination. There were 697 new carious lesions diagnosed, 446 (64%) located on coronal surfaces and 251 (36%) located on root surfaces. The mean attack rate was 0.23 surfaces/100 surfaces at risk. A treatment difference observed between the Active and Placebo groups was statistically significant for root caries increment (p = .02) and total caries increment (p = .03). A treatment difference observed between the Active and Sham groups was not statistically significant for coronal, root or total caries increment. Analysis of variance of treatment group differences was performed using mutans streptococci counts, salivary flow rates, age, sex, caries prevalence, medications, time to first event and early withdrawal as co-variables. These factors did not meaningfully alter the findings. CONCLUSIONS: The difference between the 10% chlorhexidine varnish and placebo treatments is considered to be highly clinically significant for root caries increment (41% reduction) and for total caries increment (25% reduction) but only for coronal caries increment (14%).

Aged↗

Composition of plaque and saliva following use of an alpha-tricalcium-phosphate-containing chewing gum and a subsequent sucrose challenge.

Previous studies demonstrated that the chewing of a 2.5% (mass fraction) alpha-tricalcium-phosphate-fortified (alpha-TCP) experimental chewing gum released sufficient calcium and phosphate to eliminate any fall in the tooth mineral saturation of plaque fluid after a sucrose rinse (Vogel et al., 1998). In contrast, the chewing of a conventional sugar-free gum did not eliminate this decrease in saturation. The purpose of this study was to examine if the release of ions from plaque calcium-phosphate pools induced by this gum could provide protection during subsequent exposure to cariogenic conditions. Fourteen subjects accumulated plaque for 48 hrs, fasted overnight, chewed a control or experimental gum for 15 min, and subsequently rinsed 1 min with a mass fraction 10% sucrose solution. Before gum chewing, and at 7 min and 15 min afterward, whole plaque, plaque fluid, and salivary samples were obtained and analyzed by micro-analytical techniques. Additional samples were collected and analyzed at 25 min (7 min after the sucrose rinse). Although the results confirmed the deposition of large amounts of calcium and phosphates in plaque seen in the previous study, only a small increase was seen in plaque-fluid-free calcium and phosphate before sucrose administration. This suggests that few of the mineral ions were mobilized under non-cariogenic conditions. However, 7 min after the sucrose rinsing, an increase in these concentrations was seen which, based on hydroxyapatite ion activity product calculations, indicated a decrease in the driving force for demineralization compared with that seen with the control gum. These results suggest that the chewing of the experimental gum deposits a labile mineral reservoir in plaque that can resist a subsequent cariogenic challenge.

Adult↗

Using the PerioChip in treating adult periodontitis: an interim report.

Multicenter clinical trials have established that the adjunctive use of the subgingival controlled release of chlorhexidine, in the form of the PerioChip, significantly reduces pocket probing depth, improves probing attachment levels, and reduces bleeding on probing compared to scaling and root planing alone, for periods up to 9 months. The purpose of the present study was to report on the adjunctive use of the PerioChip for the long-term management of adult periodontitis for 2 years. A total of 836 patients with adult periodontitis from private dental offices were recruited into the trial. This interim report is on the first 72 patients to have completed the 2-year study. Treatments included initial definitive therapy followed by PerioChip placement in pocket sites with a pocket probing depth of > or = 5 mm after 1 month. Subsequently, the patients received routine periodontal maintenance therapy together with the placement of a PerioChip in pockets with pocket probing depths > or = 5 mm every 3 months. Results indicated that there was a continuous decrease in pocket probing depth over the 2 years (1.26 +/- 0.77 mm). This decrease in pocket probing depth was marked over the first 9 to 12 months, and then appeared to be less marked over the next 12 months. At 2 years, 60% of the patients had at least 2 pockets showing a reduction of 2 mm or more, and only 10% of the patients showed no change or increased pocket probing depth. The results indicate that adjunctive PerioChip use is a clinically effective treatment option for dental professionals and their patients for the long-term management of adult periodontitis.

Adult↗

A calculus clinical study comparing the efficacy of two commercially available dentifrices.

The objective of this double-blind clinical study, conducted in harmony with the Volpe-Manhold design for studies of dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing pyrophosphate, tripolyphosphate and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrapotassium pyrophosphate, disodium pyrophosphate, and tetrasodium pyrophosphate in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the Northern New Jersey area were entered into the study, provided a full oral prophylaxis and assigned the use of a placebo (non-calculus-inhibiting) dentifrice for eight weeks. At the completion of this initial period, subjects were assessed for baseline Volpe-Manhold Calculus Index scores, provided another full prophylaxis and stratified into two treatment groups which were balanced for age, sex and baseline calculus. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after twelve weeks' use of the study dentifrices. Eighty-nine (89) subjects complied with the protocol and completed the entire study. At the three-month examination, the Test Dentifrice group exhibited a statistically significant 31.0% reduction in the mean Volpe-Manhold Calculus Index score compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice containing pyrophosphate, tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrapotassium pyrophosphate, disodium pyrophosphate, and tetrasodium pyrophosphate in a 0.243% sodium fluoride/silica base.

Adult↗

A clinical comparison of two calculus-inhibiting dentifrices.

The objective of this double-blind clinical study, conducted in harmony with the Volpe-Manhold design for studies of dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing pyrophosphate, tripolyphosphate and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrapotassium pyrophosphate, disodium pyrophosphate and tetrasodium pyrophosphate in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the Buffalo, New York area were entered into the study, provided a full oral prophylaxis, and assigned the use of a placebo (non-calculus-inhibiting) dentifrice for fourteen weeks. At the completion of this initial period, subjects were assessed for baseline Volpe-Manhold Calculus Index scores, provided another full prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after twelve weeks' use of the study dentifrices. Ninety-one (91) subjects complied with the protocol and completed the entire study. At the three-month examination, the Test Dentifrice group exhibited a statistically significant 27.3% reduction in mean Volpe-Manhold Calculus Index score as compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice, containing pyrophosphate, tripolyphosphate and a copolymer in a 0.243% sodium fluoride/silica base, is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrapotassium pyrophosphate, disodium pyrophosphate and tetrasodium pyrophosphate in a 0.243% sodium fluoride/silica base.

Adult↗

A twelve-week clinical comparison of two tartar control dentifrices.

The objective of this double-blind clinical study, conducted using the Volpe-Manhold evaluation method for dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the northern New Jersey area were entered into the study based on a pre-test (baseline) Volpe-Manhold Calculus Index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after twelve weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol, and completed the entire study. At the twelve-week examination, the Test Dentifrice group exhibited a statistically significant 43.5% reduction in mean Volpe-Manhold Calculus Index scores compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice, containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base, is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base.

Adult↗

A six-week clinical tooth whitening study of a new calculus-inhibiting dentifrice formulation.

This six-week double-blind clinical study compared the toothwhitening effects of a new calculus-inhibiting dentifrice containing pyrophosphate, tripolyphosphate and copolymer in a 0.243 sodium fluoride/silica base (Test Dentifrice) with two commercially available dentifrices: Aquafresh Whitening Toothpaste with Fluoride and Crest Regular Fluoride Toothpaste. After a baseline examination for extrinsic tooth stain, qualifying adult males and females from Manchester, United Kingdom and from Mississauga, Ontario, Canada were randomly assigned into three test groups. Each group was balanced for gender, tobacco habits and levels of tooth stain. Subjects were to brush their teeth twice daily with a soft-bristled toothbrush using the assigned toothpaste. One-hundred and twenty-eight (128) subjects complied with instructions and completed the trial. Subjects using the Test Dentifrice exhibited statistically less stain area and less stain intensity than did either the Aquafresh or Crest groups. Crest Regular Fluoride toothpaste was statistically less effective than Aquafresh Whitening toothpaste in removing stain. Results in this trial support the conclusion that a new dentifrice formulation containing pyrophosphate, tripolyphosphate and a copolymer, in a 0.243% sodium fluoride/silica base, effectively removes extrinsic tooth stain.

Adolescent↗