Plaque regrowth effects of a triclosan/pyrophosphate dentifrice in a 4-day non-brushing model.

Triclosan is a lipophilic antimicrobial agent which, when present in an aqueous dentifrice vehicle, is complexed by or in close contact with polymers and surface-active molecules, emulsifying agents, flavoring oils and other hydrophobic ingredients. Because of this, dentifrice products containing triclosan may not have triclosan in a bioavailable state and, hence, the products themselves can not be assumed to possess antimicrobial activity. In order to determine the antimicrobial effects on dental plaque of a triclosan/pyrophosphate dentifrice relative to a negative control (without triclosan or pyrophosphate), a crossover 4-day non-brushing study was conducted. Thirty-four subjects were enrolled in this randomized two-period, double-blind crossover investigation with thirty-three subjects completing all aspects. Following a baseline plaque examination and complete plaque removal at the start of the first 4-day treatment period, subjects initiated a twice-daily supervised dosing regimen, during which they rinsed with their first assigned dentifrice in slurry form while refraining from tooth-brushing and all other oral hygiene procedures. Evaluations to quantify test product effects on plaque were conducted on Day 5. After a week-long interim washout period, subjects repeated the twice daily rinsing regimen over Days 1-4 of Treatment Period 2 with their second assigned product, again with examinations on Day 5. Analysis of data demonstrated subjects had significantly (p = 0.0296) less plaque when rinsing with the triclosan/pyrophosphate dentifrice slurry as compared to the negative control dentifrice slurry; the relative treatment difference as determined by the primary examiner was 12.7%. A trainee examiner observed a 16.0% reduction on a subset of subjects (p = 0.0139). This efficacy result compares favorably with results from other studies of triclosan-containing products. The examinations for oral safety demonstrated no meaningful clinical differences between the triclosan/pyrophosphate dentifrice and control dentifrice.

Assessing the efficacy and safety of an electric interdental cleaning device.

BACKGROUND: Although routine interdental cleaning is important and recommended by dental professionals, compliance has been relatively low. To aid in improving compliance, an electrically powered device has been developed. METHODS: This six-month randomized, single-blinded, parallel-group study was conducted to compare the long-term efficacy and safety of a new interdental cleaning device (Braun Oral-B Interclean, model ID2) with those of an ADA-approved waxed dental floss in healthy adults. RESULTS: The authors found no statistically significant difference between the two products with respect to the gingival index or gingival bleeding index after three or six months of use. A one-time product use, at the six-month examination, confirmed the equivalency of the two methods with respect to removal of dental plaque. The oral soft-tissue status of both groups of subjects also remained comparable throughout the study. CONCLUSION: Use of the interdental cleaning device and dental floss resulted in comparable benefits with respect to gingival health and plaque removal. CLINICAL IMPLICATIONS: Although it was not shown to be an improvement over dental floss, the cleaning device was comparable in every respect. Since it can be used with one hand and does not require as much dexterity as floss, the device warrants consideration by those who lack the motivation or are unable to use dental floss.

A crossover clinical investigation of the safety and efficacy of a new oscillating/rotating electric toothbrush and a high frequency electric toothbrush.

PURPOSE: To compare the efficacy on plaque, gingivitis and calculus of an oscillating/rotating power toothbrush (Braun Oral-B Ultra Plaque Remover-D9) and a high frequency toothbrush (sonicare). MATERIALS AND METHODS: A 6-week, randomized crossover study was carried out. A total of 62 healthy adult subjects completed the study and were assessed for plaque control, gingival condition and calculus control. At the end of the study, subjects completed a questionnaire which assessed their preferences for the two devices. RESULTS: Both toothbrushes were found to be safe and effective, but a significantly lower gingival index (P = 0.002) and a lower calculus index (P = 0.022) was found in the D9 group. Assessment of patient preferences revealed that a significant majority of subjects in the study (65%) preferred the D9 to the high frequency toothbrush (27%). It is concluded that the D9 may offer greater potential for the maintenance of good gingival condition than the high frequency toothbrush, and that the greater preference for the D9 may be important with respect to long-term compliance. The implications of these findings are discussed.

The effect of chewing sugar-free gum after meals on clinical caries incidence.

To determine the effect of chewing sugar-free gum on caries incidence, the authors conducted a randomized clinical study. A total of 1,402 children in Puerto Rico, in grades 5 through 7 at baseline, completed the study. They were randomized by classroom into a control group or chewing gum group; those in the gum group were instructed to chew sugar-free gum for 20 minutes after each of three meals a day. Clinical and radiographic evaluations were performed at baseline and after two and three years. The results show that all subjects and high-risk subjects, respectively, in the gum group developed 7.9 percent and 11.0 percent fewer decayed, missing or filled surfaces than subjects in the control group. Based on these findings, the authors concluded that chewing sorbitol-based sugar-free gum after eating significantly reduces the incidence of dental caries.

An in vitro comparison between laser fluorescence and visual examination for detection of demineralization in occlusal pits and fissures.

It has been demonstrated that when excited by laser light carious enamel appears dark compared to luminescent sound enamel. The aim of this study was to compare the sensitivity and specificity of visual exams (V), laser fluorescence (LF) and dye-enhanced LF (DELF) for detecting demineralization in occlusal pits and fissures. The actual presence of lesions was determined by subsequent confocal laser microscopy (CM), which was compared to histology (H). Independent clinical examiners visually graded three sites on occlusal surfaces of extracted, human premolars as sound or carious and also rated the color of each graded site as: 0 = same as surrounding enamel; 1 = white; 2 = light brown, or 3 = brown/dark brown. An argon laser was used to illuminate the teeth for LF and DELF; the images were captured with a CCD camera and then analyzed. DELF images were captured after the teeth had been exposed to 0.075% sodium fluorescein. Sections were then cut from each specimen and analyzed by CM and H for the presence or absence of caries. Results showed that DELF (0.72) was significantly more sensitive (p<0.05) than LF (0.49) and V (0.03) for detecting caries, but there were no significant differences among the methods in specificity (V 1.00; LF 0.67; DELF 0.60). When color was used as an indication of caries in V (VC, sensitivity 0.47; specificity 0.70), V exams were not different from LF. The area under the ROC curve, using H as the gold standard and CM as the test, was 0.78. Results indicated that DELF was the best diagnostic tool and that VC and LF were equally effective as diagnostic methods, when color of fissures was included as an indication of demineralization in the visual exam.

A comparison of stabilized stannous fluoride dentifrice and triclosan/copolymer dentifrice for efficacy in the reduction of gingivitis and gingival bleeding: six-month clinical results.

This parallel-group, double-blind, placebo-controlled clinical trial directly compared the efficacy of two antimicrobial dentifrice formulations for the control of plaque, gingivitis and gingival bleeding during six months of use following a pre-test randomization period. Test antimicrobial dentifrices for the study included: a stabilized stannous fluoride formulation (Crest Plus Gum Care-currently marketed in U.S.) comprised of 0.454% SnF2 in a stabilized silica abrasive base; and a formulation containing triclosan (Colgate Total, currently marketed outside the U.S. in numerous countries) comprised of 0.30% triclosan. 2.0% Gantrez co-polymer and 0.243% NaF in a silica abrasive base. The control dentifrice was a conventional fluoride dentifrice comprised of 0.243% NaF in a silica abrasive base. Clinical evaluations included Turesky et al. plaque, Löe-Silness gingivitis and gingival bleeding, and Meckel stain. The stabilized stannous fluoride dentifrice exhibited significant efficacy in the reduction of both gingivitis (20.5%) and gingival bleeding (33.4%) after six months relative to the placebo control (p < 0.05). In direct comparison, the stabilized stannous fluoride dentifrice reduced gingivitis and gingival bleeding significantly relative to the triclosan/copolymer dentifrice (p < 0.05). These results establish: 1) the superior clinical efficacy of a stabilized stannous fluoride dentifrice relative to a triclosan/copolymer dentifrice in the chemotherapeutic control of gingivitis and gingival bleeding; 2) the important contribution of clinical test design/sensitivity in assessing the therapeutic efficacy of antimicrobial agents; and 3) the value of head-to-head comparative studies in establishing the therapeutic relevance of clinical effects of formulations for the reduction of gingivitis.

The comparative efficacy of stabilized stannous fluoride dentifrice, peroxide/baking soda dentifrice and essential oil mouthrinse for the prevention of gingivitis.

This double-blind parallel-design clinical study compared the efficacy of a stabilized stannous fluoride dentifrice (Crest Plus Gum Care), baking soda and peroxide (NaF) dentifrice (Mentadent), and essential oil mouthrinse (Listerine) to a conventional NaF dentifrice (Crest) for the control of plaque, gingivitis and gingival bleeding over six months. Following an initial baseline examination and stratification, subjects received a complete oral prophylaxis and were distributed assigned test products. Following three and six months, subjects re-visited the clinic for examinations. Evaluations at baseline and at 3 and 6 months included soft tissue status. Löe-Silness gingivitis/gingival bleeding, Silness-Löe plaque and dental stain. Results subsequent to six months of product use were as follows: At six months, the stabilized stannous fluoride dentifrice was observed to produce statistically significant 17.5% reductions in gingivitis and 27.5% reductions in gingival bleeding relative to the NaF dentifrice. The combination of sodium fluoride dentifrice and essential oil mouthrinse produced statistically significant reductions of 7.4% in gingivitis and 10.8% in plaque as compared with the NaF dentifrice. The stabilized stannous fluoride dentifrice produced statistically significant reductions in both gingivitis (10.8%) and gingival bleeding (23.0%) relative to the combination of sodium fluoride dentifrice and essential oil mouthrinse. The baking soda and peroxide (NaF) dentifrice did not provide reductions in gingivitis, plaque or gingival bleeding as compared with the conventional NaF dentifrice. The stabilized stannous fluoride dentifrice provided statistically significant reductions in gingivitis as compared with the baking soda and peroxide dentifrice following six months of use, and both the essential oil mouthrinse and stabilized stannous fluoride dentifrice provided statistically significant reductions in gingivitis as compared with the baking soda and peroxide dentifrice following three months of use. These results support: 1) the efficacy of stabilized stannous fluoride dentifrice and the combination of sodium fluoride dentifrice and essential oil mouthrinse for the prevention of gingivitis; 2) the superior activity of stabilized stannous fluoride dentifrice as compared with a combination of sodium fluoride dentifrice and essential oil mouthrinse for the control of gingivitis and gingival bleeding; and 3) the lack of efficacy for baking soda and peroxide dentifrice for the control of plaque, gingivitis and gingival bleeding as compared with conventional fluoridated dentifrice.

Quanticalc assessment of the clinical scaling benefits provided by pyrophosphate dentifrices with and without triclosan.

The Quanticalc (QC) dental scaler permits a quantitative assessment of the work used by professionals in calculus removal through the measurement of force dynamics and scaling strokes applied in calculus debridement. The purpose of this study was to use the QC to compare the clinical effects of two 5% pyrophosphate dentifrices on dental calculus in subjects following six-months' product use. Three-hundred forty-six subjects participated in a six-month, double-blind tartar control clinical trial involving traditional Volpe-Manhold Index (VMI) evaluations. Following the six-month VMI examinations, the subjects had a QC prophylaxis (scaling force measurements). The three dentifrice treatment groups included a control dentifrice (NaF only, Crest); NaF dentifrice containing 5.0% pyrophosphate (Crest Tartar Control); and NaF dentifrice containing 5.0% pyrophosphate plus 0.28% triclosan (antimicrobial). Subjects were balanced by baseline (pretest) VMI scores at the start of the trial. QC examinations revealed statistically significant reductions in total force and stroke number used by the therapist to scale the six anterior VMI teeth for subjects using the pyrophosphate tartar control dentifrices as compared to control dentifrice. The reduction in scaling effort amounted to almost 3 kg per scaling for subjects. QC results paralleled VMI reductions of calculus on the teeth and demonstrated that the use of 5% pyrophosphate dentifrices, with or without triclosan antimicrobial, results in significant reductions in the total (developed) force and strokes required by therapists in regular calculus debridement at a six-month interval. The clinical benefits of tartar control toothpastes may not only include reductions in cosmetically objectionable supragingival calculus, but in reducing professional effort in calculus debridement during regular prophylaxis.

A Quanticalc clinical comparison of professional efficiency in manual supragingival calculus debridement.

The Quanticalc (QC) dental scaler permits the assessment of work effort expended by professionals in removing supragingival calculus from the teeth. The purpose of this study was to compare the efficiency of two professionals in scaling calculus under controlled clinical conditions in like populations. One-hundred and thirty-one subjects were randomly assigned to two professionals, A and B, for QC scaling of their six Volpe-Manhold Index (VMI) teeth. VMI assessments were carried out by a separate examiner prior to QC cleaning. The QC was used to record total developed force, total strokes and force/stroke used in calculus debridement. Results demonstrated significant differences in scaling efficiency between the two professionals. These results further demonstrate the potential utility of the QC and like devices in assisting in the instruction of professionals toward the development of more efficient manual scaling procedures.

The clinical effect of a stabilized stannous fluoride dentifrice on plaque formation, gingivitis and gingival bleeding: a six-month study.

The effects of a stabilized 0.454% stannous fluoride dentifrice, currently marketed as Crest Gum Care, on supragingival plaque, gingivitis, gingival bleeding and oral soft tissue condition were studied in 328 adult male and female subjects who completed a six-month, double blind clinical study. Following initial examinations, subjects presenting with a minimum of five gingival bleeding sites received a thorough dental prophylaxis and were instructed to brush at least twice a day for three months with a commercially available fluoride dentifrice, packaged in such a way as to blind its identity to the study subjects. This constituted the three-month pre-test period. At the end of this period, subjects were again examined, given a second oral prophylaxis, and randomly assigned to brush with one of the following dentifrices: 1) stabilized 0.454% stannous fluoride, 2) 0.243% sodium fluoride control, or 3) one of three experimental dentifrices. Subjects were instructed to brush their teeth as they normally would, at least twice a day for one minute per brushing. Follow-up examinations after three and six months of dentifrice use evaluated supragingival plaque, gingivitis, gingival bleeding, extrinsic tooth stain and oral soft tissue status. After six months, the stabilized stannous fluoride dentifrice significantly reduced gingivitis and gingival bleeding by 20.5% and 33.4% compared to the sodium fluoride control group. However, the stabilized stannous fluoride dentifrice group was not significantly different from the control dentifrice group with respect to supragingival plaque scores. As expected, accumulation of extrinsic tooth stain was greater in the stabilized stannous fluoride group than the control group. No unexpected nor clinically significant oral soft tissue health effects were associated with the use of the test dentifrices. The results from this clinical study demonstrate that over a six-month period, twice-daily use of a dentifrice containing 0.454% stabilized stannous fluoride significantly reduced gingivitis and gingival bleeding, relative to a 0.243% sodium fluoride control dentifrice.

The clinical effect of dentifrices containing stabilized stannous fluoride on plaque formation and gingivitis--a six-month study with ad libitum brushing.

The effects of stabilized 0.454% stannous fluoride dentifrices on supragingival plaque, gingival inflammation and gingival bleeding were studied in 549 adult male and female subjects who completed a six-month, double blind clinical study. Following an oral prophylaxis, subjects were randomly assigned to brush with one of the following dentifrices: 1) 0.454% SnF2 stabilized with 2.08% sodium gluconate, 2) 0.454% SnF2 stabilized with 4.16% sodium gluconate, 3) an experimental dentifrice, or 4) 0.243% NaF control dentifrice. Follow-up examinations were conducted at 3 and 6 months. Compared to the control dentifrice at 6 months, stannous fluoride dentifrices stabilized with 2.08% or 4.16% sodium gluconate significantly reduced gingivitis by 18.8% and 18.0%, respectively. There were no statistically significant differences between the two stabilized SnF2 groups with respect to their beneficial effects on gingival health. Gingival bleeding was also reduced, relative to the control dentifrice, for both stabilized SnF2 dentifrices. However, these differences were not statistically significant at p=0.05. The stabilized SnF2 dentifrices were not significantly different from the control dentifrice in their effects on supragingival plaque. No significant differences in adverse oral soft tissue effects were observed between the test and control groups. As expected, accumulation of extrinsic tooth stain increased in the stabilized SnF2 groups. However, the difficulty in removing accumulated dental stain was similar between the control and stabilized SnF2 dentifrices. Since use of SnF2 dentifrices has been reported to produce tooth stain, gingivitis examinations were done with and without custom-made tooth covers to evaluate the potential for examiner bias. Comparable gingivitis and gingival bleeding benefits were observed when the evaluations were conducted with or without the tooth covers. Results from this study support that 0.454% stabilized stannous fluoride dentifrices can provide an important adjunct to the prevention and control of gingivitis when used in combination with regular personal oral hygiene procedures and professional care.

Sample size considerations in designing studies with intra-oral models.

Especially during recent years, the use of pre-clinical models for predicting the efficacy of fluoride systems has assumed greater importance within the scientific community. Originally utilized primarily to screen experimental fluoride delivery systems, preclinical models are now being considered as predictors of clinical efficacy in lieu of controlled clinical caries trials. Of the various preclinical models presently available, human intra-oral models have the greatest potential for reflecting intended usage conditions and therefore may be the most meaningful models for predicting clinical efficacy. However, only with the proper consideration of numerous critical variables can studies using intra-oral models be appropriately designed to achieve the desired objectives. Clearly, these models must provide relevant information in a manner which reflects clinically established cariostatic activity and be capable of detecting established differences in the amount of cariostatic activity, i.e., dose-response effects. Three sources of variation must be considered before an appropriate study design and sample size can be chosen. Based on fluoride uptake data from an intra-oral model with proximally-located enamel specimens, estimates of variation among subjects, within subjects, and among specimens within subjects were obtained. Multiple specimens per panelist do not affect the first two sources of variation. Thus, the number of panelists, and not the number of specimens, is of primary importance when pre-test data are used to choose the appropriate study design and calculate the required sample size.

Clinical effects of a 0.12% chlorhexidine rinse as an adjunct to scaling and root planing.

This trial tested the adjunctive effects of a 0.12% chlorhexidine rinse (Peridex) upon gingival healing following scaling and root planing. Assessments were made on reduction in plaque (Pl), gingivitis (GI), pocket depth and gingival bleeding as measures of treatment benefit. All subjects had Class II, III or IV periodontal conditions. Following baseline examinations, subjects received a gross supragingival scaling and polishing. Subjects were separated by sex and periodontal classification, arrayed by GI scores, and randomly assigned to either the chlorhexidine rinse or a placebo rinse. Subjects were instructed to rinse with 1/2 ounce of their assigned products for 30 seconds twice daily. Following two weeks of product use, the clinical examinations were repeated and two randomly selected, opposing contralateral quadrants were scaled and root planed. After two more weeks of product use (week 4), clinical examinations were repeated and the remaining quadrants were scaled and root planed. At week 6, final clinical examinations were conducted. Since half-mouths were treated at different times and exposed to the treatment rinses for different periods, the data were analyzed for the half-mouths independently 2 and 4 weeks after gross scaling, and 2 and 4 weeks after root planing. A total of 94 subjects (47 in each treatment group) completed all phases of the trial. Gingival healing following scaling and root planing in subjects using a chlorhexidine rinse (0.12%) was significantly better than subjects using the placebo rinse as evidenced by less gingivitis (29%), fewer GI bleeding sites (48%) and less plaque (54%).

Mouthwash and oral cancer.

Recently, a small but significant relationship has been identified between the use of over-the-counter mouthwash preparations containing greater than 25 percent alcohol and the development of oral cancer. This paper reviews the medical and dental literature, discusses the implications of long-term, excessive mouthwash use and makes recommendations regarding the use of mouthwash with a high alcohol content.

The clinical effects of a mouthrinse containing 0.1% octenidine.

The purpose of this three-month clinical trial was to evaluate the effects of a 0.1% octenidine mouthrinse on plaque, gingivitis, extrinsic dental stain, and the oral soft tissues. A total of 451 adult volunteer subjects was initiated into the study and given baseline dental examinations. The subjects were stratified into two balanced groups according to gender, plaque, and gingivitis scores. The subjects then received a dental prophylaxis and were provided with dentifrice, toothbrushes, and either a mouthrinse containing 0.1% octenidine dihydrochloride as the active ingredient or a similar placebo mouthrinse. Subjects were instructed to rinse with their assigned product for 30 s twice each day. Examinations were repeated at six weeks (soft-tissue assessment, gingivitis) and three months (soft tissues, plaque, gingivitis, dental stain). The results showed that the group rinsing with 0.1% octenidine had significantly less plaque (39%), gingivitis (50%), and bleeding sites (60%) than the group using the control product, but had significantly higher stain formation and experienced longer prophylaxis times to remove the stain. The oral soft-tissue examinations revealed no differences in the groups in either the numbers or types of lesions noted.

The relative plaque removal effect of a prebrushing mouthrinse.

A total of 51 adult subjects participated in a three-period crossover trial to test plaque-removal effectiveness of a prebrushing mouthrinse. Subjects refrained from brushing to allow plaque to accumulate for 24 hours before the test. The accumulated plaque was graded using Turesky's method. The subjects then used one of three treatment regimens, were retested for accumulated plaque and regraded. The three treatments tested were a commercial prebrushing mouthrinse and no toothbrushing; a commercial prebrushing mouthrinse and brushing with a dentifrice for 30 seconds; a prebrushing water rinse and brushing with a dentifrice for 30 seconds. The analysis of the data found that both groups that brushed removed significantly more plaque than the group that did not brush. However, both the prebrushing rinse group and the water rinse group achieved the same amount of plaque removal through 30 seconds of toothbrushing with a dentifrice.

The comparative clinical cariostatic efficacy of sodium fluoride and sodium monofluorophosphate dentifrices: a review of trials.

This report reviews the methods and findings of published clinical studies comparing dentifrices containing sodium fluoride (NaF) and sodium monofluorophosphate (Na2PO3F) for the purpose of determining whether sodium fluoride formulations have superior cariostatic effects. Nine of ten reported trials found a numerical advantage for sodium fluoride dentifrices with highly compatible abrasive systems and the hypothesis that these two fluoride agents have equivalent cariostatic effects is rejected (p = 0.011). Therefore, the collective clinical evidence demonstrates that dentifrices containing NaF have greater cariostatic effectiveness than dentifrices containing Na2PO3F.

A clinical evaluation of the relative cariostatic effect of dentifrices containing sodium fluoride or sodium monofluorophosphate.

A three-year clinical trial was conducted to determine whether a sodium fluoride (NaF) dentifrice had greater cariostatic effects than a sodium monofluorophosphate (Na2PO3F) dentifrice. Both dentifrices contained 1100 ppm fluoride and silica abrasive systems. A panel of 3,290 children, age 6-16, received one of the two dentifrices for ad libitum home use. The subjects were examined for caries at the baseline and after 2 and 3 years. Results were analyzed both for all children and for those children age 11 years or older at the baseline. The older children were found to have about 50 percent higher new caries increments than did the entire panel of children. In the older, caries- prone children, the subjects using the NaF product experienced significantly (15 percent and 12 percent) fewer new lesions than did the subjects using the Na2PO3F product after 2 and 3 years respectively. In the panel of all children, subjects using the NaF product had numerically, but not significantly, fewer new lesions. The results for this study, showing significantly greater cariostatic benefits in caries-prone children for a sodium fluoride dentifrice with a highly compatible system, are consistent with findings of other investigators.

Effects of nicotine chewing gum on complete dentures and their soft-tissue-bearing areas.

One hundred six edentulous subjects were given nicotine-containing chewing gum to evaluate the ability to chew the gum, to observe the adherence of the gum to denture-base materials, and to evaluate the effect of gum chewing on denture-bearing tissues. Prior to the 13-week study, the denture-bearing ridges and the tissue and polished surfaces of the denture were evaluated clinically and photographed. Questionnaires were used to elicit personal habits of the subjects. Of the 59 subjects completing the study, most could manipulate and chew the gum effectively, three-fourths reported that gum adherence was not a problem, and no adverse reaction to oral tissues was observed.

Clinical effect of a sanguinaria dentifrice on plaque and gingivitis in adults.

A clinical trial was conducted to evaluate the effects of a sanguinaria-zinc chloride dentifrice on the prevention of plaque formation and gingivitis. A total of 59 young adults, 18 to 30 years of age, either performed supervised brushing with a 0.075% sanguinaria-0.05% zinc chloride dentifrice, a 0.24% sodium fluoride dentifrice, or rinsed daily with a 0.05% NaF solution. Clinical evaluations for plaque and gingivitis were performed after 7, 14, and 21 days of the test regimen. After 21 days, all subjects resumed twice daily supervised brushing and flossing and post-test evaluations were conducted after two weeks. The results showed that after 7, 14, and 21 days both groups using dentifrices had significantly less plaque and gingivitis than the group using the rinse, and there were no significant differences between the two groups using either the sanguinaria-ZnCl2 or the NaF dentifrices.