Clinical evaluation of the Jay Sensitivity Sensor Probe: a new microprocessor-controlled instrument to evaluate dentin hypersensitivity.

PURPOSE: To compare the Jay Sensitivity Sensor Probe (Jay Probe), a new microprocessor-based, pre-calibrated instrument, with well accepted methods used to evaluate sensitivity, i.e. tactile response to the Yeaple Probe, air blast (Schiff scale), and patient responses by Visual Analog Score (VAS). METHODS: Jay Probe assessments were accomplished using several approaches. With a cohort of 12 subjects, two clinical examiners compared the repeatability of the Jay and Yeaple Probes. A second evaluation of both probes was conducted during two independent parallel design clinical studies each enrolling 100 adults with dentin hypersensitivity (DH). In each study, subjects were evaluated for DH responses after twice daily oral hygiene with a negative control fluoride dentifrice or a positive control dentifrice formulated with ingredients proven to reduce sensitivity, i.e. potassium nitrate or 8.0% arginine with calcium carbonate. Tactile evaluations by the Jay and Yeaple Probes were conducted at baseline and recall visits over the 8-week duration of each study. Also evaluated at each visit were responses to air blast and to patient reported DH assessment by VAS. RESULTS: Low inter-examiner variability with no significant differences between replicate measurements (P > 0.05) was observed with the Jay Probe. Consistent with results from previous studies, subjects assigned dentifrices formulated with potassium nitrate or 8% arginine/calcium carbonate demonstrated improvements in Yeaple, air blast and VAS responses in comparison to those assigned the fluoride dentifrice (P < 0.05). Jay Probe responses correlated significantly with all other sensitivity measures (P < 0.05). Differences between these treatments were observed at all post-treatment evaluations using these methods.

Assessment of hypersensitivity reduction of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% NaF and specially-designed silica as compared to a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate and zinc lactate and to a dentifrice containing 0.243% NaF on dentin hypersensitivity reduction: an 8-week study.

PURPOSE: To evaluate the 8-week dentin hypersensitivity efficacy of three toothpastes: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride and specially-designed silica (Test Dentifrice 1); (2) a commercially-available dentifrice containing 0.454% stannous fluoride in a silica base with sodium hexametaphosphate and zinc lactate (Test Dentifrice 2); and (3) a commercially-available non-sensitive dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). METHODS: For this 8-week randomized controlled clinical study, qualifying subjects had to have at least two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force, and air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale). Subjects brushed twice daily for 1 minute, using the assigned toothpaste and toothbrush. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at the baseline examination and after 4 and 8 weeks of brushing. RESULTS: 118 subjects complied with the protocol, and completed the 8-week study. At baseline, the mean tactile sensitivity scores for toothpastes (1), (2) and (3) were 13.6, 14.1 and 13.1; at 4 weeks 28.75, 20.13, and 20.00; and after 8 weeks 33.1, 24.0 and 20.5, respectively. The mean air blast scores for toothpastes (1), (2), and (3) at baseline were 2.5, 2.5, and 2.4; at 4 weeks 1.25, 1.50 and 1.85; and after 8 weeks 0.99, 1.36 and 1.5, respectively. At all time points after the baseline examination, for both tactile and air blast sensitivity scores, the differences between Test Dentifrice 1 and the Negative Control Dentifrice were statistically significant (P < 0.05). The differences between Test Dentifrice 1 and Test Dentifrice 2 were statistically significant (P < 0.05) at 4 and 8 weeks after baseline examination for tactile sensitivity scores and at 8 weeks after baseline examination for air blast sensitivity scores.

Efficacy of three toothbrushes on established gingivitis and plaque.

PURPOSE: To evaluate the efficacy of three toothbrushes [Colgate 3600 Deep Clean (AFT version), the Colgate 3600 Deep Clean (stapled version) and the Oral B Indicator] on the removal of established gingivitis and plaque. METHODS: This examiner-blind, three-treatment, parallel clinical research study assessed plaque removal via the comparison of pre-to- post-brushing and 4-week plaque removal measured by the Rustogi Modification of the Modified Navy Plaque Index. This study also assessed gingivitis using the Löe & Silness Gingival Index. Qualifying adult male and female subjects from the Northern New Jersey area reported to the study site after refraining from any oral hygiene procedures for 12 hours; and from eating, drinking, or smoking for 4 hours. Following an examination for gingivitis and plaque (pre-brushing), they were randomized into three balanced groups, each group using one of the three study toothbrushes in the order specified by a pre-determined randomization plan. Subjects were instructed to brush their teeth for 1 minute under supervision with their assigned toothbrush and a commercially-available toothpaste (Colgate Cavity Protection), after which they were once again evaluated for plaque (post-brushing). Subjects were then dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next 4 weeks. They again reported to the study site at which time they were evaluated for plaque and gingivitis. RESULTS: 109 subjects complied with the protocol and completed the clinical study. For plaque removal, comparisons were made for whole mouth, at the gingival margin and at interproximal sites. The results of the study indicated that all three test toothbrushes provided statistically significantly reductions in pre- to post-brushing plaque index scores of up to 44.0%, 38.6% and 23.6% respectively, after a single toothbrushing. Relative to the Oral B Indicator toothbrush, the Colgate 360 degree Deep Clean toothbrush (AFT version) and Colgate 360 degrees Deep Clean toothbrush (stapled version) provided a statistically significantly greater removal of plaque of up to 107% and 93.0%, respectively, after a single toothbrushing. Also, the group using the Colgate 360 degree Deep Clean toothbrush (AFT version) and the Colgate 360 degree Deep Clean toothbrush (stapled version) exhibited a statistically significantly greater removal of plaque of up to 575% and 400%, respectively, when compared to the Oral B Indicator toothbrush after 4 weeks. The group using the Colgate 3600 Deep Clean toothbrush (AFT version) and the Colgate 3600 Deep Clean toothbrush (stapled version) exhibited statistically significantly greater reductions in gingivitis of up to 23% and 17%, respectively, and greater reductions in gingivitis severity (bleeding sites) of up to 73% and 52% respectively, as compared to the Oral B Indicator toothbrush after 4 weeks. There was no statistically significant difference between the two Colgate 3600 toothbrushes for any parameter and at any comparison time.

A clinical study to assess the anticalculus efficacy of a new dentifrice containing a special grade of silica (Colgate Total Plus Whitening Toothpaste): a clinical trial on adults.

The objective of this double-blind clinical study, conducted using the Volpe-Manhold design for studies of dental calculus, was to confirm the supragingival anticalculus efficacy of a formulation variant of a commercially available anticalculus dentifrice. The commercially available dentifrice (Colgate Total Toothpaste) contains 0.3% triclosan and 2.0% PVM/MA copolymer in a 0.243% sodium fluoride/silica base. The new formulation variant contains those same ingredients, of which 10% of the silica is a high cleaning grade (Colgate Total Plus Whitening Toothpaste). In this study, the dentifrice formulation variant was tested for anticalculus efficacy against a negative control dentifrice containing 0.243% sodium fluoride/silica. 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 eight weeks' use of the study dentifrices. Sixty-three (63) subjects complied with the protocol and completed the entire study. At the eight-week examination, subjects in the Colgate Total Plus Whitening Toothpaste group exhibited a statistically significant 34.13% reduction in mean Volpe-Manhold Calculus Index score as compared to the negative control dentifrice group. Thus, the results of this clinical study support the conclusion that a new dentifrice formulation variant containing a special grade of silica (Colgate Total Plus Whitening Toothpaste) is efficacious for the control of the formation of supragingival calculus.

The effect of brushing time and dentifrice on dental plaque removal in vivo.

PURPOSE: Routine toothbrushing is the principal method by which individuals remove plaque and control plaque-related diseases, such as periodontitis and caries. Oral health care professionals generally recommend at least 2 minutes brushing with an appropriate technique, and yet the average brushing time in the general population is closer to 45 seconds. Our understanding of the relationship between brushing time and plaque removal, in an untutored general population using a conventional manual toothbrush and dentifrice, is limited. The role of dentifrice in plaque removal is also unclear. METHODS: This study was undertaken to measure plaque removal during untutored brushing over timed periods between 30 and 180 seconds with 1.5 g dentifrice, using an Aquafresh Flex brush and Aquafresh Advanced dentifrice. Plaque removal after brushing without dentifrice was also determined (at the 60 second time point only). Forty-seven subjects participated in the study, in which plaque level was assessed using the Quigley-Hein (Turesky-modification) Index. RESULTS: Plaque removal increased with brushing time across the range studied, tending towards a maximum at longer brushing times. At the extremes, brushing for 180 seconds removed 55% more plaque than brushing for 30 seconds. Brushing for 120 seconds removed 26% more plaque than brushing for 45 seconds. The use of dentifrice did not increase plaque removal during 60 seconds of brushing. CONCLUSIONS: Oral health care professionals should reinforce efforts to persuade patients to brush for longer periods of time, as increasing brushing time to the consensus minimum of 2 minutes from a more typical 45 seconds increases plaque removal to an extent likely to provide clinically significant oral health benefits.