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PubMed2002

Extrinsic stain prevention with a combination dentifrice containing calcium phosphate surface active builders compared to two marketed controls.

A six-week, randomized and controlled, examiner blind, parallel group clinical trial was conducted to evaluate the stain prevention efficacy of an experimental whitening dentifrice containing a combination of sodium hexametaphosphate and soluble pyrophosphate relative to a marketed high-abrasive dentifrice and a marketed control dentifrice. Following the collection of baseline stain scores and subsequent prophylaxis, healthy volunteers were randomized to one of three treatment regimens, balancing for stain levels and smoking status. Throughout the six-week treatment period, subjects brushed twice daily with the assigned dentifrice while following a rinse regimen of three times daily tea and once daily chlorhexidine. At baseline, three and six weeks, dental stain was measured on the facial and lingual surfaces of the eight anterior teeth using the Lobene Index. A total of 96 subjects completed the study. At three and six weeks, adjusted stain scores were highest in the control group and generally lowest in the sodium hexametaphosphate group for all Lobene parameters (intensity, area and composite). At three weeks, stain area and composite stain scores for the sodium hexametaphosphate dentifrice were statistically significantly (p < 0.05) lower relative to the control, representing reductions of 30% and 33%, respectively. Similar numerical trends were observed after six weeks, with the sodium hexametaphosphate group showing reductions of 21% (p = 0.068) in stain area and 26% (p = 0.055) in composite stain relative to the control. The high-abrasive dentifrice was directionally, though not statistically superior to the control at three and six weeks. All three test products were well-tolerated.

Adult↗
PubMed2002

Comparative intraoral tolerance of sodium hexametaphosphate and pyrophosphate antitartar dentifrices.

A randomized, controlled clinical trial was conducted to assess the relative acute oral tolerance of a novel, dual-phase, tartar control dentifrice containing 7.0% sodium hexametaphosphate (5% hexametaphosphate anion). In this 4-day study, 159 healthy adult volunteers were randomly assigned to the experimental sodium hexametaphosphate dentifrice or a marketed, single-phase, antitartar dentifrice control containing 5.0% ionic pyrophosphate. A detailed oral soft tissue examination and interview were conducted each day by blinded evaluators to elicit clinical signs and symptoms associated with ad libitum use of the assigned dentifrice. A total of 24 subjects (15% of the study population) had new symptoms/signs after baseline. By treatment, 9% of subjects in the sodium hexametaphosphate group had new findings, compared to 21% of subjects in the pyrophosphate group, and these groups differed statistically (p < 0.03, two-sided) with respect to occurrence. In addition, onset, severity, duration and clinical presentation were generally milder in the sodium hexametaphosphate group compared to the pyrophosphate control. Only one subject (in the pyrophosphate group) discontinued treatment early due to oral intolerance. In this study, the 7.0% sodium hexametaphosphate dentifrice was well-tolerated, with significantly fewer symptoms and superior overall tolerance compared to the marketed antitartar dentifrice control.

Adult↗
PubMed2002

In vitro studies of the anticalculus efficacy of a sodium hexametaphosphate whitening dentifrice.

Laboratory studies involving crystal growth inhibition and plaque biofilm calcification were conducted to confirm the anticalculus potential of a dual-action whitening dentifrice containing sodium hexametaphosphate, a novel, enamel-safe, antitartar agent. Calcium hydroxyapatite crystal growth was significantly inhibited following direct supernate treatments by hexametaphosphate in solution and when formulated into the dual-action whitening dentifrice. Similarly, plaque biofilm calcification was significantly inhibited by supernate treatments of the hexametaphosphate whitening dentifrice. The activity of hexametaphosphate dentifrice in plaque biofilm calcification protocols exceeded that produced by commercial dentifrices containing polycarboxylic acid, metal ion and pyrophosphate tartar control ingredients. Results predict excellent clinical activity for hexametaphosphate dentifrice for the prevention of supragingival calculus formation. Published double-blind, randomized clinical studies confirm the validity of these laboratory models for the screening of potentially improved tartar control ingredients.

Complex Mixtures↗
PubMed2002

Bacterial detachment from salivary conditioning films by dentifrice supernates.

This study compared the detachment by supernates of nine different dentifrices of four oral bacterial strains adhering to a salivary pellicle in a parallel plate flow chamber. Ultra-thin bovine enamel slabs were coated for 1.5 h with human whole saliva. Following buffer rinsing, a bacterial suspension of Streptococcus oralis, Streptococcus sanguis, Streptococcus mutans or Actinomyces naeslundii was perfused through the flow chamber at a shear rate of 30 s-1 for four hours, and the number of adhering bacteria n4h was enumerated by image analysis after buffer rinsing at the same shear rate. Then, a 25 wt%-dentifrice/water supernate was perfused through the flow chamber for four minutes, followed by eight minutes of buffer rinsing and another enumeration of the number of bacteria that had remained adhering nad. Finally, an air-bubble was passed through the flow chamber to mimic the occasionally high detachment forces occurring in the oral cavity, and the adhering bacteria nab were counted again. On average, S. sanguis was the easiest to detach (73% averaged over all dentifrice supernates), while A. naeslundii was the most difficult (22% on average). The combined detachment of bacteria by dentifrice supernates and air-bubble ranged from a low of 16% to a high of 80%. Dentifrices containing pyrophosphate and polymeric polyphosphate (hexametaphosphate) surface active ingredients appeared to produce the most consistent and strongest desorption effects on plaque bacteria. Factors apparently important to bacterial detachment from pellicle-covered tooth surfaces by dentifrice formulations include the nature of adhesion of bacterial strains and chemical composition of the dentifrice formulations, including pH, surfactant system and the effect of added ingredients (dispersants, metal ions, peroxides, baking soda).

Actinomyces↗
PubMed2002

Removal of extrinsic stain using a 7.0% sodium hexametaphosphate dentifrice: a randomized clinical trial.

A nine-week, randomized and controlled clinical trial was conducted to compare the stain removal efficacy of a 0.243% sodium fluoride dentifrice containing 7% sodium hexametaphosphate (5% hexametaphosphate anion) to that of a 0.243% sodium fluoride control dentifrice. Following prophylaxis and a three-week pre-treatment period to induce extrinsic stain, healthy adult volunteers with tooth stain were randomized to the sodium hexametaphosphate dentifrice or the control. Stain area and intensity were assessed at baseline, three and six weeks. At both three and six weeks, the sodium hexametaphosphate dentifrice was statistically significantly superior to the control for all overall stain measures (p < 0.04). After six weeks of product usage, the sodium hexametaphosphate dentifrice demonstrated reductions of 29% in composite stain, 24% in stain intensity, and 25% in stain area relative to the control. Significant reductions in composite stain were seen on both gingival and body regions for the sodium hexametaphosphate dentifrice versus the control at three and six weeks. Both products demonstrated favorable safety profiles, as determined by oral soft tissue evaluations and recording of subject-reported adverse events.

Adolescent↗
PubMed1996

A microbiological and clinical study of the safety and efficacy of baking-soda dentifrices.

This article reports the results of a study that examined the clinical and microbiological changes associated with regular use of baking-soda dentifrices. Two dentifrice formulations were examined in a 6-month longitudinal study of 101 adult subjects with assessments for plaque, gingival inflammation, and stain at baseline and 3 and 6 months during the active phase of the study, and at 3 months after cessation of product use. One dentifrice contained 52% baking soda and 3% sodium percarbonate (Arm & Hammer PeroxiCare) while the other dentifrice contained 65% baking soda (Arm & Hammer Dental Care). Both dentifrices resulted in statistically significant reductions in dental plaque, gingival inflammation, and stain at all time periods compared to baseline. Dental plaque and buccal soft-tissue samples were obtained for microbiological analysis from a 50-subject subset. Microbiological assays, including bacterial culture, phase-contrast microscopy, and immunofluorescence microscopy, confirmed the safety of both formulations. Beneficial alterations in dental plaque bacteria were noted, including significant reductions in the levels of Actinomyces species. The data from this study indicate that dentifrices containing high levels of baking soda are clinically effective and microbiologically safe.

Actinomyces↗
PubMed2002

A study to assess the tooth whitening efficacy of a new dentifrice formulation variant containing a special grade of silica: a six-week study on adults.

The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a formulation variant of a commercially available dentifrice (Colgate Total Plus Whitening Toothpaste) obtained by the addition of high cleaning silica, relative to that of its currently marketed formulation (Colgate Total Toothpaste). Following a baseline examination, qualifying adult male and female subjects were randomized into two treatment groups which were balanced for age, gender and level of extrinsic tooth stain. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. After one, and again after two weeks' use of the assigned dentifrices, a randomly selected panel of subjects was examined for soft tissue findings. Examinations for extrinsic tooth stain were repeated for all subjects after six weeks' use of the study dentifrices. Ninety-seven (97) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the new dentifrice formulation group exhibited statistically significantly (p < 0.05) lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Colgate Total Toothpaste group. Thus, the results of this double-blind clinical study support the conclusion that the new dentifrice formulation variant is efficacious for the removal of extrinsic tooth stain.

Adult↗
PubMed2002

The clinical efficacy of a new tooth whitening dentifrice formulation: a six-month study in adults.

The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a formulation variant of a commercially available dentifrice (Colgate Total Plus Whitening Toothpaste) obtained by the addition of high-cleaning silica, relative to that of its currently marketed formulation (Colgate Total Toothpaste). Following a baseline examination for extrinsic tooth stain, qualifying adult male and female subjects from New Jersey and Florida were randomized into two treatment groups which were balanced for gender, age, and level of extrinsic tooth stain. 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 extrinsic tooth stain were repeated after six-weeks', three-months' and six-months' use of the study dentifrices. Eighty-six (86) subjects complied with the protocol and completed the entire study. At the six-month examination, subjects assigned to the new dentifrice formulation group exhibited statistically significantly lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Colgate Total Toothpaste group. Thus, the results of this double-blind clinical study support the conclusion that the new dentifrice formulation variant is efficacious, compared to the control dentifrice, for the removal of extrinsic tooth stain.

Adult↗
PubMed2000

Anticalculus effect of two zinc citrate/essential oil-containing dentifrices.

PURPOSE: To assess the feasibility of incorporating zinc citrate, a known anticalculus ingredient, into a dentifrice formulation containing a fixed combination of essential oils, a known antiplaque/antigingivitis agent. MATERIALS AND METHODS: This randomized, parallel, double-blind study evaluated the potential of two essential oil dentifrice formulations containing different levels of zinc citrate (1.0% and 2.0% ZCT) to reduce supragingival calculus formation compared to a marketed control dentifrice, Crest Regular. Following a 3-month pre-test phase, subjects received a dental prophylaxis, were stratified into three balanced groups on the basis of Volpe-Manhold calculus scores and brushed twice daily with their assigned dentifrice for 3 months. RESULTS: One hundred ninety-six evaluable subjects completed all phases of the study. ANCOVA revealed that the 1.0% ZCT and 2.0% ZCT essential oil dentifrice formulations provided significant reductions in calculus formation of 26.4% and 29.0% (P< 0.001), respectively, compared to the control dentifrice, Crest Regular. The magnitude of calculus reductions is similar to those levels obtained by other zinc salt formulations.

Adolescent↗
PubMed2000

Clinical effectiveness of essential oil-containing dentifrices in controlling oral malodor.

PURPOSE: To assess the efficacy of two essential oil-containing dentifrices in the reduction of human intrinsic oral malodor ("morning bad breath"). MATERIALS AND METHODS: Two clinical trials were conducted which used observer-blind, negative control, parallel designs. To insure a homogeneous test population with similar oral odor characteristics, subjects followed instructions that included toothbrushing with a standard ADA-accepted fluoride dentifrice the night before. On odor evaluation days, subjects refrained from all oral hygiene procedures and from eating or drinking any food or beverage or smoking prior to and during the odor evaluations. Eighty healthy adult subjects in the first trial and 90 in the second trial with qualifying baseline levels of oral malodor participated. Odor ratings of each subject's breath were made by 4-5 trained judges using a nine point hedonic scale, i.e., 1 = most pleasant, 5 = neutral, 9 = most unpleasant. Qualifying subjects were randomly assigned one of two essential oil dentifrices or a negative control dentifrice. Subjects brushed with their assigned dentifrice for 60 s, rinsed with 20 ml of water for 10 s, and received post-treatment hedonic odor ratings at 30, 60, 90, 120, 180, and 240 min. Data were analyzed using an ANCOVA to adjust for baseline scores. RESULTS: The essential oil dentifrices were significantly more effective (P < or = 0.033) than the control in reducing intrinsic oral malodor from 90 to 120 min.

Adult↗
PubMed1997

A microbiological and clinical study of the safety and efficacy of baking-soda dentifrices.

This article reports the results of a study that examined the clinical and microbiological changes associated with regular use of baking-soda dentifrices. Two dentifrice formulations were examined in a 6-month longitudinal study of 101 adult subjects with assessments for plaque, gingival inflammation, and stain at baseline and 3 and 6 months during the active phase of the study, and at 3 months after cessation of product use. One dentifrice contained 52% baking soda and 3% sodium percarbonate (Arm & Hammer PeroxiCare) while the other dentifrice contained 65% baking soda (Arm & Hammer Dental Care). Both dentifrices resulted in statistically significant reductions in dental plaque, gingival inflammation, and stain at all time periods compared to baseline. Dental plaque and buccal soft-tissue samples were obtained for microbiological analysis from a 50-subject subset. Microbiological assays, including bacterial culture, phase-contrast microscopy, and immunofluorescence microscopy, confirmed the safety of both formulations. Beneficial alterations in dental plaque bacteria were noted, including significant reductions in the levels of Actinomyces species. The data from this study indicate that dentifrices containing high levels of baking soda are clinically effective and microbiologically safe.

Adolescent↗
PubMed2002

Caries prevention in Chinese children with sodium fluoride dentifrice delivered through a kindergarten-based oral health program in China.

Caries in China appears to be a significant problem, especially among preschool children. The effect of caries prevention in the primary teeth of preschool children through the use of fluoridated dentifrices and prevention programs has not been widely addressed. The purpose of this study was to examine the caries preventive effects of an 1100 ppm sodium fluoride dentifrice used in the context of a kindergarten-based oral health program compared to a matched placebo dentifrice in the absence of a kindergarten-based oral health program. This was a randomized, placebo-controlled, examiner-blind, two-year caries study. A population of 1,334 preschool school children, three years of age, was recruited from 24 school kindergartens in Huairoi and Miyun counties, located approximately 60 kilometers northeast of Beijing, China. Classrooms were stratified based on mean baseline dmfs scores derived from the visual-tactile baseline examination, and randomly assigned to one of the two dentifrice treatment groups: 0.243% sodium fluoride (1100 ppm fluoride ion) or placebo (0 ppm fluoride ion). Children attending the schools participating in the program brushed twice a day (morning and afternoon) at school under the supervision of classroom teachers during the school week. The children randomized to schools receiving the placebo dentifrice were supplied with toothbrushes and dentifrice for ad libitum use at home and did not participate in the school program or supervised classroom brushing. For the primary examiner, the two-year caries increment data demonstrated evidence of anticaries efficacy for the sodium fluoride dentifrice/school program group as compared to the placebo/no school program group. In the evaluable subset, the 1100 ppm fluoride treatment group had a 20.7% reduction in dmfs compared to the placebo treatment group, that was statistically significant (p = 0.004). The secondary examiner observed a similar overall treatment effect, as the 1100 ppm fluoride treatment group had an 22.1% reduction in dmfs compared to the placebo treatment group that was statistically significant (p = 0.014). In contrast to the primary examiner, there was a county-by-treatment interaction for the secondary examiner's results necessitating that the counties be examined independently. In Miyun county, the sodium fluoride/school program group had a 39.9% reduction in caries compared to the placebo/no program group that was statistically significant (p = 0.001). In Huairou county, the sodium fluoride/school program group had a 6.8% reduction in caries compared to the placebo/no program group that was not statistically significant (p > 0.05). These results demonstrate that fluoride in conjunction with increased dental awareness can deliver important reductions in caries in preschool children.

Cariostatic Agents↗
PubMed2002

Clinical comparison of the stain-removal efficacy of a novel liquid whitening gel containing 18% carbamide peroxide and a commercially available whitening dentifrice.

The objective of this examiner-blind clinical study was to compare the extrinsic tooth-stain removal efficacy of a novel, nontray, "paint-on" liquid whitening gel containing 18% carbamide peroxide (Colgate Simply White Clear Whitening Gel) with a commercially available whitening dentifrice. After a baseline examination for extrinsic tooth stain, qualifying adult men and women from Canada were randomized into two treatment groups balanced for age, gender, and level of extrinsic tooth stain. Subjects were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice (Group 1: nonwhitening dentifrice; Group 2: whitening dentifrice). The subjects in Group 1 also were instructed to use the paint-on whitening gel for 30 minutes twice daily. Examinations for extrinsic tooth stain were repeated after 2 and 3 weeks. Ninety-seven subjects complied with the protocol and completed the entire study. At both the 2- and 3-week examinations, subjects assigned to the liquid whitening gel-treatment group exhibited statistically significant reductions in extrinsic tooth stain (P < .05) with respect to stain area (22.7% reduction at 3 weeks), stain intensity (26.3% reduction at 3 weeks), and overall stain removal (32% reduction at 3 weeks) compared with the commercially available whitening dentifrice group. Thus, the results of the examiner-blind clinical study support the conclusion that Colgate Simply White Clear Whitening Gel provides a significantly greater level of extrinsic tooth-stain removal efficacy than a commercially available whitening dentifrice.

Adolescent↗
PubMedDate not supplied

Clinical effect of a triclosan-containing dentifrice on plaque and gingivitis: a six-month study.

A total of 294 adult male and female subjects completed a 6-month, double-blind clinical trial designed to evaluate the effects of a dentifrice which contained 0.3% triclosan in conjunction with 2% of a methoxyethylene/maleic acid copolymer in a 0.243% sodium fluoride/silica base, relative to a control dentifrice, on supragingival plaque accumulation and gingivitis. Plaque and gingivitis were scored after 3 and 6-month use of the assigned dentifrice. At the end of the study, the triclosan group showed an average reduction, relative to the control group, of 12% in plaque accumulation and 20% in gingivitis. Both were statistically significant at p < or = 0.0001. The effect of the triclosan dentifrice was most pronounced on the more severe manifestations of plaque and gingivitis. The improvement in the gingival parameters at 6-months relative to the control dentifrice was statistically significant at p < or = 0.0001. It was concluded that the twice-daily use of the triclosan-containing dentifrice resulted in significant reduction in supragingival plaque formation and a significant improvement in gingival health without the presence of any extrinsic staining or objectionable taste.

Adolescent↗
PubMedDate not supplied

A pilot study of preschoolers' use of regular-flavored dentifrices and those flavored for children.

Ingestion of fluoride dentifrice by preschool children recently has been implicated as a risk factor for dental fluorosis. The availability of dentifrices flavored for children could increase fluoride ingestion by young children at risk for dental fluorosis. This article reports results of a pilot study of use of regular-flavored dentifrice and those flavored for children among 29 preschool children. Using a crossover design, larger quantities of fluoride dentifrice specially flavored for children were used compared with the quantities of regular-flavored dentifrice. Pediatric dentists and other health care providers should advise parents to supervise preschoolers' toothbrushing. Preschoolers should use only small, pea-sized quantities of dentifrice to avoid increased risks of dental fluorosis.

Child, Preschool↗
PubMed1992

Clinical effectiveness of a dentifrice containing potassium chloride as a desensitizing agent.

Sensodyne F, a dentifrice currently marketed in the United Kingdom, containing potassium chloride (KCl) and sodium monofluorophosphate (MFP) was compared to a placebo dentifrice for effectiveness in alleviating dentinal hypersensitivity. This randomized, double-blind, parallel clinical study covered 12 weeks of product use by 41 subjects. Hypersensitivity levels of the affected teeth were assessed by tactile stimulation, cold air stimulation and overall subjective patient response. The results from these three methods of assessment demonstrated that the KCl/MFP dentifrice was significantly more effective than the placebo dentifrice in reducing dentinal hypersensitivity. The therapeutic response to the KCl/MFP dentifrice as measured by air sensitivity and overall subjective evaluation was statistically significant when compared to the placebo dentifrice within 4 weeks of use. Significant improvement was observed for all parameters at the conclusion of the 12-week clinical study period. Plaque reduction was significantly reduced at week 8 and continued to improve by week 12. The results indicate that KCl with sodium MFP significantly reduced dentinal hypersensitivity and improved overall patient comfort.

Adolescent↗
PubMed2004

Clinical response of three whitening products having different peroxide delivery: comparison of tray, paint-on gel, and dentifrice.

OBJECTIVE: Comparative clinical research was conducted to evaluate the efficacy and safety of three peroxide-containing tooth whitening products having different peroxide delivery. METHODOLOGY: A total of 43 healthy adults who met entrance criteria were randomly assigned to either a dual-phase, anticavity, 1% hydrogen peroxide dentifrice with a manganese gluconate activator, an 18% carbamide peroxide paint-on gel, or a 5% carbamide peroxide professional custom tray system. Following manufacturer's instructions, the activated dentifrice was used at least twice daily for two minutes, while the paint-on gel was applied twice daily. The custom tray, a barrier system and the experimental control for this study, was worn continuously for six to eight hours daily. Tooth color (L*a*b*) was measured on the maxillary anterior teeth from standard digital images, while safety was assessed from examination and subject report. RESULTS: At Day 15, the custom tray group had a significant (p < 0.002) reduction in yellowness and increased lightness, with adjusted mean (SE) deltab* of -1.83 (0.210) and deltaL* of 1.45 (0.292). The custom tray group experienced on average greater color improvement compared to either the paint-on gel or activated peroxide whitening dentifrice, differing significantly (p < 0.01) from either of the barrier-free systems with respect to deltab*, deltaL*, deltaE*, and deltaW*. In comparison, 14-days' use of the paint-on gel and activated dentifrice did not result in significant (p > 0.10) color improvements from baseline for deltab*, deltaL*, or deltaW*, with these two barrier-free systems not differing significantly (p > 0.26) with respect to any individual or composite color parameters. Tooth sensitivity and oral irritation were the most common safety findings in the tray and dentifrice groups (there were no adverse events in the paint-on group), and no subject discontinued treatment early because of a treatment-related adverse event. CONCLUSION: In head-to-head 14-day testing, a low concentration (5% carbamide peroxide) barrier-based tray system yielded superior tooth color improvement compared to two barrier-free delivery systems-an 18% carbamide peroxide paint-on gel and a 1% hydrogen peroxide dentifrice with a metal activator.

Adolescent↗
PubMed1991

[Inhibiting effect of a pyrophosphate-dentifrice on calculus formation].

Anticalculus dentifrices containing pyrophosphate salts have been shown to reduce calculus formation. The purpose of this double-blind, cross-over study was to compare the effects of a pyrophosphate dentifrice with a placebo on supragingival calculus formation in highly calculus-prone subjects. 60 volunteers completed a compliance period during which meticulous full-mouth scaling was performed. Subjects were randomly assigned either to placebo (F-Antibelag Gel) or to the test group (F-Antibelag Gel + K4P2O7/Na4P2O7). Participants were told to brush twice daily with their assigned dentifrice, use only the brushes provided and to abstain from any other oral hygiene procedures. After a three month period a second full-mouth scaling was performed, and according to the cross-over design of this study the participants used the alternative placebo or, respectively, dentifrice for another three months. Baseline scores and control scores after 1, 2 and 3 months were obtained using the Volpe-Manhold-Index and the Marginal-Line-Calculus-Index. A micromorphological SEM Calculus Index was introduced using replicas from interdental areas of mandibular incisors (score 0-3). Both test groups showed significantly less accumulation of supragingival calculus of 25.5% (VMI) and 19.5% (MLCI) and significantly less SEM detectable calculus (24%) with the pyrophosphate dentifrice than with the placebo. It is concluded that the test dentifrice inhibits the formation of calculus.

Adult↗