Clinical evaluation of the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity.

PURPOSE: To determine the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate relative to that of a commercially-available pumice prophylaxis paste in reducing dentin hypersensitivity instantly after a single application following a dental scaling procedure and to establish the duration of sensitivity relief over a period of 4 weeks and 12 weeks. METHODS: This was a single-center, parallel group, double-blind, stratified clinical study conducted in San Francisco, California, USA. Qualifying adult male and female subjects who presented two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10-50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were stratified according to their baseline hypersensitivity scores and randomly assigned within strata to one of two treatment groups: (1) A Test Paste, a desensitizing paste containing 8% arginine and calcium carbonate (Colgate-Palmolive Co); and (2) A Control Paste, Nupro pumice prophylaxis paste (Dentsply Professional). Subjects received a professionally-administered scaling procedure, after which they were re-examined for tactile and air blast dentin hypersensitivity (Post-Scaling Examinations). The assigned pastes were then applied as the final step to the professional dental cleaning procedure. Tactile and air blast dentin hypersensitivity examinations were again performed immediately after paste application. Subjects were provided with a commercially-available non-desensitizing dentifrice containing 0.243% sodium fluoride (Crest Cavity Protection, Procter & Gamble Co.) and an adult soft-bristled toothbrush and were instructed to brush their teeth for 1 minute, twice daily at home using only the toothbrush and dentifrice provided, for the next 12 weeks. Subjects returned to the testing facility 4 and 12 weeks after the single application of Test or Control paste, having refrained from all oral hygiene procedures and chewing gum for 8 hours and from eating and drinking for 4 hours, prior to each follow-up visit. Assessments of tactile and air blast hypersensitivity, and examinations of oral soft and hard tissue were repeated at these 4- and 12-week examinations. RESULTS: 68 subjects completed the 12-week study. No statistically significant differences from baseline scores were indicated at the Post-Scaling Examinations for either the Test Paste or Control Paste groups. Immediately following product application and 4 weeks after product application, subjects assigned to the Test Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (44.1% and 45.9% respectively) and mean tactile hypersensitivity scores (156.2% and 170.3% respectively). At the same time points, subjects assigned to the Control Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (15.1% and 8.9% respectively) and mean tactile hypersensitivity scores (43.1% and 8.3% respectively). Immediately following application of the assigned paste and 4 weeks later, the Test Paste group demonstrated statistically significant reductions in dentin hypersensitivity with respect to baseline-adjusted mean air blast (34.1% and 40.6% respectively) and mean tactile hypersensitivity scores (79.0% and 149.6% respectively), compared to the Control Paste group. No statistically significant differences were exhibited between paste groups at the Post-Scaling and 12-week examinations with respect to mean tactile and baseline-adjusted mean air blast hypersensitivity scores.

The efficacy of a newly designed toothbrush to decrease tooth sensitivity.

OBJECTIVE: 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. METHODOLOGY: 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 tactile and thermal sensitivity of the baseline-designated sensitive teeth. Examinations of the oral soft and hard tissues also were performed at these followup visits. RESULTS: At the 4-week examinations, patients exhibited a statistically significant 5.49-unit increase in tactile sensitivity score and a statistically significant 0.77-unit decrease in thermal sensitivity score, both indicative of improvements in tooth sensitivity. At the 8-week examinations, patients exhibited a statistically significant 13.78-unit increase in tactile sensitivity score and a statistically significant 1.85-unit decrease in thermal sensitivity score, again both indicative of improvements in tooth sensitivity. CONCLUSION: It can be concluded that brushing sensitive teeth with the new Colgate 360 degrees Sensitive toothbrush will result in a decrease in tooth sensitivity and this decrease in tooth sensitivity will increase over time.

A clinical investigation of the efficacy of two dentifrices for the reduction of supragingival calculus formation.

OBJECTIVE: The objective of this double-blind clinical study, conducted in harmony with Volpe-Manhold design for studies of dental calculus, was to compare 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) to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste) with respect to the reduction of supragingival calculus formation. METHODS: Adult male and female subjects from the San Francisco area were entered into the eight-week pre-test phase of the study. Subjects received an evaluation of oral soft and hard tissues and were given a complete oral prophylaxis. They were provided with a non-tartar control placebo dentifrice and a soft-bristled adult toothbrush, and were instructed to brush their teeth twice daily (morning and evening) for one minute. After eight weeks of using the placebo dentifrice, subjects were examined for baseline supragingival calculus formation using the Volpe-Manhold Calculus Index. Qualifying subjects were randomized into two treatment groups which were balanced for gender and baseline calculus scores. All subjects entered into the twelve-week test phase were given a complete oral prophylaxis, and were provided with their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute twice daily (in the morning and evening). Prior to each study visit, subjects refrained from brushing their teeth and eating and drinking for four hours. RESULTS: Seventy-seven (77) subjects complied with the protocol and completed the study. At the twelve-week examination, the Test Dentifrice group presented a mean Volpe-Manhold Calculus Index score of 13.22 and the Control Dentifrice group presented a score of 20.29. After twelve weeks of product use, the Test Dentifrice group exhibited 34.8% less supragingival calculus formation than the Control Dentifrice group (statistically significant at p < 0.05). CONCLUSION: The overall results of this double-blind clinical study support the conclusion that after twelve weeks' use of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base provides significantly greater control of supragingival calculus formation relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base.

Anticalculus effect of a cetylpyridinium chloride/zinc gluconate mucoadhesive gel: results of a randomized, double-blind, controlled clinical trial.

OBJECTIVE: This randomized, double-blind, controlled clinical trial investigated the anticalculus effect of a cetylpyridinium chloride/ zinc gluconate (CPC/ZG) mucoadhesive gel. METHODOLOGY: The 80 adults from the San Francisco area who fulfilled the enrollment criteria were stratified based on total Volpe-Manhold Index (VMI) scores (low, medium, or high), gender, and other demographic data. Within these strata, they were randomly assigned to the CPC/ZG gel group or the placebo gel group, and underwent a baseline oral soft tissue (OST) examination. Subjects were dispensed Oral-B Indicator 35 Compact Head soft toothbrushes and Colgate Cavity Protection MFP toothpaste, and instructed to brush twice daily using these products. Every night for three months, following the nighttime brushing and just before retiring, subjects applied their assigned treatment gel to the lingual surfaces of the six mandibular anterior teeth. They were instructed not to eat or drink until morning and to avoid using other methods of interdental cleaning between the treated teeth, except to remove impacted food. Total VMI scores and OST examination findings obtained at three months were compared with baseline findings. RESULTS: Seventy-eight (78) of the 80 subjects complied with the protocol and completed the study. After three months of treatment, the CPC/ZG group showed a 30% decrease in mean VMI score compared with a 0% decrease in the placebo group. OST examination at three months revealed no serious adverse events in either group. CONCLUSION: Results of this clinical trial indicate that regular use of the CPC/ZG gel, with or without the use of floss or other interdental cleaning products, yields a statistically significant reduction in calculus.

An anticalculus dentifrice with sodium hexametaphosphate and stannous fluoride: a six-month study of efficacy.

AIM: To compare the anticalculus efficacy of an experimental dentifrice (0.454% stabilized stannous fluoride/sodium hexametaphosphate) with a negative control. METHODS AND MATERIALS: This was a randomized, examiner-blind, parallel group study. After a three-month run-in, qualifying subjects were randomized to the experimental or control dentifrice to use twice a day for six months. Volpe-Manhold Index (V-MI) and oral soft tissue examinations were conducted at baseline, three, and six months. Additional analyses were performed separately at three and six months on three subgroups categorized into high, medium, and low calculus-forming subjects. RESULTS: Compared to the control group, the experimental dentifrice group had a mean calculus score statistically significantly lower at both three months (50%) and six months (55%) post-treatment (p<0.001). Compared to control scores, mean experimental dentifrice calculus scores at three and six months were statistically significantly lower at both points in time for high, medium, and low calculus forming sub-groups (p<0.001). Both products were generally well tolerated. CONCLUSION: The experimental dentifrice revealed significant anticalculus efficacy compared to the control regardless of levels of baseline calculus formation. CLINICAL SIGNIFICANCE: The stannous fluoride/sodium hexametaphosphate dentifrice technology is an effective calculus inhibitor for home care.

Efficacy and safety of a novel stabilized stannous fluoride and sodium hexametaphosphate dentifrice for dentinal hypersensitivity.

PURPOSE: Dentinal hypersensitivity is a common complaint among dental patients. Recently, a novel 0.454% stabilized stannous fluoride dentifrice containing sodium hexametaphosphate (SHMP) was introduced that offers a desensitizing benefit. This trial was conducted to assess the desensitizing efficacy of this new dentifrice relative to a sodium fluoride control dentifrice. METHODS AND MATERIAL: This was a double-blind, parallel-group, randomized clinical trial conducted according to the American Dental Association (ADA) Guidelines for the Acceptance of Products for the Treatment of Dentinal Hypersensitivity. Ninety subjects who met the entrance criteria were stratified based on age, gender, and baseline sensitivity scores and randomly assigned to either the stabilized stannous fluoride + SHMP dentifrice (Crest Pro-Health) or the sodium fluoride control dentifrice. Subjects were instructed to brush twice daily for eight weeks. Efficacy assessments were made, including tactile (Yeaple probe) and thermal (Schiff Air Index) sensitivity, and an oral soft tissue examination was conducted at baseline, week four, and week eight. RESULTS: The mean sensitivity score based on the Schiff Air Index for the stannous fluoride + SHMP group was statistically significantly lower than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had an adjusted mean 44% lower than that of the control group. The mean tactile sensitivity score for the stannous fluoride + SHMP group was statistically significantly higher, indicating a reduction in sensitivity, than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had a mean desensitizing improvement of 71% greater than the control. CONCLUSION: The stabilized stannous fluoride + SHMP dentifrice provided statistically significant reductions in dentinal hypersensitivity at four and eight weeks compared to the sodium fluoride control dentifrice.

A clinical investigation of the efficacy of three different treatment regimens for the control of plaque and gingivitis.

OBJECTIVE: 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. METHODOLOGY: 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 the original packaging to which overwrapping had been applied. Subjects were instructed to brush their teeth for one minute twice daily (morning and evening) using only the dentifrice provided, and to refrain from using anything other than their assigned oral hygiene products for the duration of the study. In addition, subjects were instructed to refrain from any routine dental treatment (except emergency) during the course of the study. There were no restrictions regarding diet or smoking habits over the course of the study. Examinations for gingivitis and supragingival plaque, and oral soft tissue assessments were repeated after three months, and again after six months of product use. RESULTS: One-hundred fourteen (114) subjects complied with the protocol and completed the six-month examinations. Statistical analyses showed similar results for both whole-mouth and interproximal scoring sites after six months of product use. Although not statistically significant, subjects using Colgate Total Toothpaste accompanied by the use of dental floss had numerically lower six-month scores for gingivitis and supragingival plaque formation when compared to the scores of subjects using Colgate Total Toothpaste without the use of dental floss. Relative to the sodium fluoride toothpaste accompanied by the use of dental floss, subjects using Colgate Total Toothpaste, both with and without the use of dental floss, exhibited statistically significant reductions in gingivitis and supragingival plaque formation after six months of product use. CONCLUSION: The results of this clinical study support the conclusion that the use of Colgate Total Toothpaste, both with and without the use of dental floss, provided statistically significant improvements over the sodium fluoride toothpaste plus flossing regimen with respect to the control of gingivitis and supragingival plaque formation. Although not statistically significant, numerically lower six-month scores for gingivitis and supragingival plaque were associated with Colgate Total Toothpaste accompanied by the use of dental floss, when compared with Colgate Total Toothpaste without the use of dental floss.

Anticalculus efficacy and safety of a stabilized stannous fluoride/sodium hexametaphosphate dentifrice.

The purpose of this study was to assess the anticalculus efficacy and long-term safety of a new stannous fluoride dentifrice containing sodium hexametaphosphate. This trial was a randomized, double-blind, parallel-group, 6-month study where, after a prophylaxis, subjects brushed twice daily with either a stabilized 0.454% stannous fluoride/13% sodium hexametaphosphate dentifrice (Crest Pro-Health) or a marketed multibenefit triclosan/copolymer control dentifrice. Study subjects were known to form supragingival calculus and had previously demonstrated the ability to form at least 1.5 mm using the Volpe-Manhold Calculus Index over a 2-month pretest period. Comparisons between treatments for anticalculus efficacy were performed using analysis of covariance. Eighty subjects were randomized into one of two treatment groups after stratification on gender and baseline calculus scores and then monitored for calculus formation, soft tissue tolerance, and extrinsic stain. The mean calculus score for the stannous fluoride/sodium hexametaphosphate group was statistically significantly lower than that of the triclosan/copolymer group at both months 3 and 6 (P < .01). At month 3, the stannous fluoride/sodium hexametaphosphate group had an adjusted mean 54% lower than that of the triclosan/copolymer group. At month 6, the stannous fluoride/sodium hexametaphosphate group had an adjusted mean 56% lower than that of the triclosan/copolymer group. Both dentifrices were well tolerated and neither dentifrice group developed appreciable extrinsic stain over the 6-month trial period. Overall, the stannous fluoride/sodium hexametaphosphate dentifrice had superior anticalculus efficacy relative to the marketed triclosan/copolymer control and a comparable soft tissue safety and extrinsic stain profile.

Desensitizing effect of a stabilized stannous fluoride/Sodium hexametaphosphate dentifrice.

Stannous fluoride (0.4%) has been incorporated into oral hygiene products to reduce dentinal hypersensitivity since the 1960s. The present study was designed to assess the desensitizing efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice compared to a sodium fluoride control dentifrice. This was a double-blind, parallel-group, randomized clinical trial conducted according to the American Dental Association Guidelines for the Acceptance of Products for the Treatment of Dentinal Hypersensitivity. Seventy-seven subjects who met the entrance criteria were stratified based on age, gender, and air-sensitivity scores and randomly assigned to either the stabilized stannous fluoride/sodium hexametaphosphate dentifrice or the sodium fluoride control dentifrice. Subjects were instructed to brush twice daily for 8 weeks. Oral soft tissue examination and efficacy assessments including tactile (Yeaple probe) and thermal (Schiff Air Index) sensitivity were made at baseline, week 4, and week 8. The mean sensitivity score based on the Schiff Air Index for the experimental group was statistically significantly lower than that of the sodium fluoride control group, at both weeks 4 and 8 (P < .0001). The mean sensitivity score based on the Yeaple Probe Index for the stannous fluoride/sodium hexametaphosphate group was statistically significantly higher, indicating a reduction in sensitivity, than that of the sodium fluoride control group, at both weeks 4 and 8 (P < .0001). The results demonstrate that the stabilized stannous fluoride/sodium hexametaphosphate dentifrice provides clinically and statistically significant reductions in dentinal hypersensitivity when compared to the sodium fluoride control dentifrice.

An in vivo evaluation of the diagnostic quality ultra-speed versus insight intraoral dental film.

Twelve sets of FMS (full mouth survey) radiographs were taken by California licensed radiology technicians. Ten of the sets of FMS radiographs were taken using Ultra-Speed "D" film on the left side of the patient and Insight "F" speed film on the right side of the patient. The remaining two sets of films were taken using Insight Film on both sides of the patient to act as a control. Ten faculty members of the Diagnostic Department were asked to evaluate the twelve sets of FMS radiographs and report whether they had a preference for the right side, left side, or no preference. Criteria for preference were diagnostic ability and clarity of the films. The results of the study showed a preference for the right side (65.7%), which was imaged with Insight Film, compared to the left side (34.3%), which was imaged with Ultra-Speed Film.

Efficacy of a dentifrice containing 5 per cent potassium nitrate and 1500 PPM sodium monofluorophosphate in a precipitated calcium carbonate base on dentinal hypersensitivity / Eficácia do dentifrício contendo 5 por cento de nitrato de potássio e 1500 ppm de monofluorofosfato de sódio na base do carbonato de cálcio na hipersensibilidade dentinária

The effect on dentinal hypersensitivity from the use of a dentifrice containing 5.0 per cent potassium nitrate, 1500 ppm sodium monofluorophosphate in a precipitated calcium carbonate (PCC) base over an eight-week period was compared to a placebo dentifrice without potassium nitrate. A total of forty-eight subjects were entered into the study and stratified into two balanced groups according to their baseline mean thermal (air blast) and tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the potassium nitrate/PCC dentifrice or a placebo dentifrice without potassium nitrate. The two groups were well balanced with regard to their mean baseline thermal tactile sensitivity scores, sex and age...