三氯羟苯醚/共聚体牙膏与非共聚体牙膏对牙菌斑、牙龈炎的临床效果

目的 :比较市售三氯羟苯醚 /共聚体牙膏与非共聚体牙膏对减少成年人牙菌斑、牙龈炎的效果。方法 :采用双盲、分层、平行的临床研究 ,对 183名健康成年人 (试验组 89人、对照组 94人 )进行了为期 6个月的临床效果评价。按同一标准 (Quigley HeinPlI ,Loe SilnessGI)于试验前、试验后 3月、6月分 3次对受试对象的菌斑与牙龈炎状况进行了检查。试验对象每日使用分配的牙膏和软毛牙刷早晚刷牙各 1次。结果 :三氯羟苯醚共聚体与非共聚体牙膏均能有效地抑制菌斑与牙龈炎。试验 3月、6月 ,菌斑指数试验组与对照组比较差异无显著。牙龈炎指数三氯羟苯醚 /共聚体牙膏与非共聚体牙膏比较分别降低 13 .46% (P >0 .0 5 ) ,2 5 .86% (P <0 .0 5 )。结论 :每天两次使用三氯羟苯醚 /共聚体牙膏与不含共聚体的牙膏都能显著减少牙菌斑、改善牙龈健康。而含三氯羟苯醚 /共聚体牙膏在改善牙龈健康方面更优于不含共聚体的牙膏。     

Effects of triclosan/copolymer dentifrice on dental plaque and gingivitis in a 3-month randomized controlled clinical trial: influence of baseline gingivitis on observed efficacy

Triclosan is a broad-spectrum antimicrobial agent widely used in oral care products. In recent studies, a triclosan/pyrophosphate dentifrice has shown efficacy against dental plaque but not gingivitis. Further, experimental gingivitis studies on triclosan itself and in combination with other dentifrice ingredients demonstrate only moderate antimicrobial activity. In contrast, there are a number of other studies in the literature reporting the antigingivitis efficacy of triclosan/copolymer and triclosan/zinc citrate dentifrices. These dentifrices possess similar effects on dental plaque to triclosan/pyrophosphate, thus the lack of effect on gingivitis from triclosan/pyrophosphate was unexpected since comparable effects on dental plaque from similar formulations may infer similar antimicrobial activity and duration of action within the oral cavity. Therefore, the objective of this research was to understand the clinical variables important to observe the reported effects for triclosan dentifrice so this clinical model could in turn be used to test the effects of the triclosan/pyrophosphate dentifrice on gingivitis. To achieve this objective, it was determined that a suitable approach was to duplicate the methodology of previous successful clinical trials on triclosan/copolymer dentifrice in order to better understand the study design used to demonstrate the antigingivitis efficacy of triclosan-containing dentifrices. To this end, a prospective trial was conducted employing the same active product, clinical site, investigator and gingivitis/plaque examiner previously used. The study was a randomized, blinded, placebo-controlled, parallel group 3-month trial, which recruited subjects with L?e-Silness Gingival Index (GI) scores > or = 1.0 and Turesky Plaque Index (PI) scores of > or = 1.5. The study population consisted of 160 adults who brushed twice daily with either triclosan/copolymer or placebo control (containing copolymer) following a prophylaxis. Gingivitis and plaque were measured using the GI and PI, respectively, and scores were analyzed using a one-way analysis of covariance. There was no evidence that 3-month gingivitis or plaque scores (whole mouth or severity index) for the triclosan/copolymer group were different from the placebo group. Additional analyses were conducted on study population subgroups with increasing intervals of baseline GI bleeding sites to gauge the effect of baseline bleeding on the treatment effect. For subjects in the > or = 40 bleeding sites subset, triclosan/copolymer demonstrated a 4.2% GI and 15% gingivitis severity index reduction versus placebo at 3 months (0.10 < p < 0.20). These findings suggest that a study design which includes subjects with greater numbers of gingival bleeding sites at baseline may have the required sensitivity to demonstrate treatment benefits for triclosan/copolymer. However, additional experimental parameters remain to be fully articulated in order to replicate previously successful trials. The overall results of this trial are consistent with the experimental gingivitis results, and indicate that, even when formulated with the copolymer, triclosan as an oral antimicrobial agent possesses limited activity as an antigingivitis ingredient.     

Comparison between 3 triclosan dentifrices on plaque, gingivitis and salivary microflora

Abstract 3 triclosan-containing dentifrices were compared in a 6-month, un-supervised tooth brushing study. The effects on plaque, gingival bleeding and certain salivary micro-organisms (mutans streptococci, lactobacilli, total counts of streptococci and total counts of micro-organisms) were evaluated. 123 subjects were divided into 4 groups according to severity of gingival bleeding index. 112 subjects completed the study. Following a 4-week pre-experimental period, using a sodium monofluorophosphate dentifrice (placebo), the subjects were assigned to use one of 3 triclosan-containing dentifrices, available on the Swedish market: Colgate Paradent (a triclosan/copolymer dentifrice) (n=26); Pepsodent Gum Health (a triclosan/zinc citrate dentifrice) (n=31); Dentosal Friskt Tandkött (a triclosan/pyrophosphate dentifrice) (n=28); or to continue with the placebo (n=21). The results revealed that Colgate Paradent reduced baseline plaque values by 39% (Quigley and Hein) over the 6-month experimental period. The corresponding values for the other modalities were: a reduction of 6% for Pepsodent Gum Health, an increase of 5% for Dentosal Friskt Tandkött. and an increase of 2% for placebo. A significant difference in the plaque levels (p<0.05) was found between Colgate Paradent and Pepsodent Gum Health and between Colgate Paradent and placebo. The gingival bleeding index was improved in all 4 groups. A significant difference (p<0.05) was found with respect to bleeding between Colgate Paradent and placebo (p<0.05) at the 3-month registration. A statistically significant increase over time in total number of streptococci and total colony forming units were found for the Dentosal, Pepsodent and placebo groups, but not for Colgate. To conclude, this study seems to verify that a dentifrice containing a combination of triclosan and copolymer is effective in reducing supra-gingival plaque formation and gingival bleeding without causing major shifts in the salivary microflora.     

Triclosan/pyrophosphate dentifrice: dental plaque and gingivitis effects in a 6-month randomized controlled clinical study

A double-blind, parallel, randomized and controlled clinical trial was conducted on 186 subjects over six months to assess the effects of a 0.28% triclosan/5% pyrophosphate (with NaF/silica) dentifrice on dental plaque and gingivitis as compared to a NaF/silica negative control dentifrice. An initial examination was performed to assess the health of the oral soft and hard tissues and to measure plaque (by Turesky modified Quigley-Hein Plaque Index), gingivitis (by L?e-Silness Gingival and Ainamo and Bay Gingival Bleeding [GBI] indices). Only those subjects with a GBI score > or = 5 were accepted into the study. Each enrolled subject received an oral prophylaxis and was requested to brush and floss twice per day with the negative control NaF/silica dentifrice. After one month, the subjects were recalled and a baseline examination was performed for each of the previously described parameters. Following the baseline examination, the subjects received another oral prophylaxis. The subjects were then separated by gender and by baseline GBI scores of < or = 7 or > 7 and arrayed by the changes in GBI bleeding sites from initial to baseline. Within strata, subjects were randomly assigned to brush twice per day with either the triclosan/pyrophosphate dentifrice or the negative control dentifrice. The subjects were subsequently examined for all of the above-described parameters following use of the test dentifrices for five weeks, three and six months. The data generated in this trial were analyzed using an analysis of covariance on all indices for all subjects completing the examinations. The results from this study demonstrated that the use of the triclosan/pyrophosphate dentifrice resulted in statistically significant reductions of dental plaque compared to the control by 10% (p < 0.05), 15.4% (p < 0.01) and 13.9% (p < 0.01) at five weeks, three and six months, respectively. However, there were no statistically significant differences between the test dentifrices for any of the gingivitis or gingival bleeding evaluations throughout the study. Based on 1) the fact that subjects possessed plaque-induced gingivitis in this clinical study, 2) the similarity in the magnitude of the plaque reductions observed from the triclosan/pyrophosphate dentifrice relative to those reported for other triclosan-containing dentifrices, 3) the similarity in the dose of triclosan relative to other triclosan dentifrices, and 4) the reported magnitude of gingivitis reductions from other triclosan-containing dentifrices, these findings were unexpected. Possible explanations of these results are that the triclosan/pyrophosphate dentifrice may be uniquely different from other triclosan dentifrices relative to its effects on gingivitis, or alternatively, the clinical design utilized here may not be optimized for triclosan/pyrophosphate dentifrice.     

Effect of triclosan dentifrices on mouth volatile sulphur compounds and dental plaque trypsin-like activity during experimental gingivitis development

BACKGROUND: The objective of this study was to evaluate the effect of three commercial anti-plaque dentifrices containing 0.3% triclosan + 2% pvm/ma (Colgate Total), 0.3% triclosan + 0.75% Zn (Signal Global) and 0.3% triclosan + 5% PPi (Crest Complete) in comparison with an experimental dentifrice (0.3% triclosan + 2% pvm/ma + 0.75% Zn + 4% PPi) and a control dentifrice without anti-plaque agents on trypsin-like activity in dental plaque (detected by the hydrolysis of [Na-Benzoyl-DL-Anginine p-Nitroanilide (BAPNA)] and volatile sulphur compounds (VSCs) in mouth air during experimental gingivitis development. METHOD: A 5-step double blind, crossover experimental gingivitis study was conducted on 19 volunteers during a 21-day period. The volunteers refrained from brushing an experimental quadrant of teeth. The dentifrices were applied to those teeth via toothshield three times per day; simultaneously they brushed the other teeth with the same dentifrice. After each period, VSCs in mouth air and BAPNA hydrolysis by dental plaque accumulated in the experimental quadrant were determined. RESULTS: There was an increase (p < 0.05) in VSCs in mouth air when experimental gingivitis was induced in only one quadrant of teeth. None of the dentifrices was able to avoid the increase of VSCs during the experimental gingivitis development. The majority of the antiplaque dentifrices evaluated reduced the increase of VSC formation in comparison with the control (p < 0.05). There was no relationship between the ability of the dentifrices in reducing VSC formation and the inhibition of trypsin-like activity in dental plaque. CONCLUSIONS: Anti-plaque dentifrices reduce the increase of VSCs that occurs during the development of experimental gingivitis.     

A clinical methods study of the effects of triclosan dentifrices on gingivitis over six months

The basic design for human clinical trials which examine prevention of gingivitis recurrence is well known. However, the anti-gingivitis efficacy of triclosan-containing dentifrices has not been routinely demonstrated using this design, regardless of formulation. In an effort to better understand the subtleties of design which show triclosan efficacy, a study was undertaken to prospectively test how subjects with a range of baseline disease levels (which encompassed the range of gingivitis severity documented in the triclosan literature) benefit from a triclosan dentifrice. This trial was a randomized, double-blind, parallel group, six-month study where subjects brushed twice daily with either triclosan/pyrophosphate, triclosan/copolymer, triclosan placebo or sodium fluoride control (NaF) dentifrice following a prophylaxis. Both gingivitis and bleeding were measured using the L?e-Silness Gingival Index (GI) and plaque was measured using the Turesky Plaque Index. Comparisons between treatments were performed using an analysis of covariance. At month 3, the triclosan/pyrophosphate group had a relative mean plaque benefit of 14.4% versus the triclosan placebo group (with an associated p-value of 0.004), and subjects using triclosan/copolymer had a mean reduction in GI bleeding sites of 16.2% relative to those brushing with the NaF control (with an associated p-value of 0.031). The overall results did not demonstrate a treatment effect for gingivitis or plaque for either triclosan-containing dentifrice at month 6. There was evidence of modest anti-gingivitis efficacy in the triclosan placebo. In an effort to better understand how baseline disease severity may have impacted the trial outcome, additional analyses were performed to investigate whether the magnitude of a triclosan effect was related to baseline gingivitis levels. An analysis of covariance model incorporating a baseline group interaction effect indicated that the magnitude of the treatment differences depended on the baseline scores The effect was most pronounced for GI bleeding sites. Further analysis showed that differences between triclosan dentifrices and the NaF control dentifrice were only present for subjects with more than 33 to 63 bleeding sites, depending on the specific comparison. These findings were illustrated through a series of subset analyses on subjects with > or = 20 (entire study population), > or = 31, > or = 40 and > or = 45 baseline GI bleeding sites. The magnitude of the treatment effect for both GI and GI bleeding sites increased with each succeeding subset. Unlike that required for other antimicrobial agents used in oral care products, these findings suggest that a study design which includes subjects with more severe gingivitis at baseline has the required sensitivity to demonstrate treatment benefits for triclosan dentifrices.     

Effect of aloe vera mouthwash on dental plaque and gingivitis indices in children: A randomized controlled clinical trial

BackgroundThere is a tendency nowadays to encourage the use of natural substances in dentistry. Aloe vera is one of these substances, which has recently gained great importance in clinical research.ObjectivesTo evaluate the effectiveness of Aloe vera mouthwash in improving plaque, gingival and gingival bleeding indices in children.Materials and methodsThe study sample consisted of (17) children [age: (8) to (12) years]. The crossover design was applied, which means that the three types of mouthwashes (experimental “Aloe vera”, positive control “chlorhexidine”, and negative control “placebo”) would be used for all participants, with a washout period of (12) days. A special plaque guard was fabricated to facilitate localized plaque accumulation for (3) days. After that period, the mouthwashes were applied for (5) days. Plaque, gingival and gingival bleeding indices were studied before plaque accumulation (T0), after plaque accumulation (T1), and after applying the mouthwashes (T2). The values of plaque index (PI), gingival index (GI) and gingival bleeding index (GBI) were measured at each studied time point (T0, T1, and T2). Then, the differences between the values at the beginning of the use of each type of the mouthwashes and at the end of the period of there use were compared.ResultsThe results showed the efficacy of Aloe vera mouthwash in improving plaque, gingival and gingival bleeding indices, which was similar to chlorhexidine mouthwash effectiveness when both compared to the placebo mouthwash.ConclusionsThe use of Aloe vera mouthwash is effective in improving oral health and preventing gingivitis.     

The effect of a triclosan-containing dentifrice on established plaque and gingivitis

Abstract The aim of the present clinical trial was to study the effect on existing plaque and gingivitis of an oral hygiene regimen which utilized a dentifrice which contained triclosan. 120 subjects were recruited for the trial. They were examined for plaque and gingivitis using the criteria of (i) the Turesky modification of the Quigley & Hein plaque index and (ii) the Löe & Silness gingival index. Plaque and gingivitis were assessed in all parts of the dentition and at 6 location points around each tooth. Following a baseline examination, the subjects were stratified in 2 balanced groups based on age, plaque and gingivitis scores. The subjects were randomly assigned to the following treatment: 1 test group used a dentifrice containing triclosan/copolymer/fluoride and 1 control group used a traditional fluoride containing dentifrice. The participants were given the assigned dentifrice and a soft-bristled toothbrush for home use. They were instructed to brush their teeth in the morning and in the evening for one minute each time. They were re-examined 6 weeks, 3 and 6 months after the baseline examination. The findings from the re-examinations revealed that an oral hygiene regimen which utilized a dentifrice which contained triclosan/copolymer significantly reduced pre-existing plaque and gingivitis above what was accomplished by a traditional fluoride containing dentifrice. The improvement of the gingival conditions occurred in all parts of the dentition and at all tooth surfaces and units. In addition, the present data support the hypothesis that triclosan may induce alterations in the quality of existing plaque.     

Design and analysis of plaque and gingivitis clinical trials

It is most important that the proper design of a clinical trial be developed prior to the start of the study. Such a design is one that will not tend to find a treatment to be effective when it really is ineffective, and will not tend to miss a good treatment when it really is effective. The questions to be answered by a clinical trial must be decided in advance and will help determine the design. Trials should take into consideration how the agent is to be used: carefully controlled, ordinary use, subject or professionally applied, etc. The double-blind parallel randomized trial is preferred to the double blind cross-over design, except possibly for a professionally applied treatment which does not leach into the saliva or affect the oral microflora. Blocking or stratification tends to increase the efficiency of a clinical trial, and also may produce more information on the agent's effectiveness. Stratification is preferred to blocking, particularly when subjects enter the trial serially over time. Subjects should be stratified by age, sex and baseline level of plaque or gingivitis. Stratification permits a check on whether the effect of treatment is atypically strong or weak for certain types of patients. Where possible, the same examiner should examine the same patients throughout the study. Examiners should be self-calibrated to reduce intra-examiner error. Plaque and gingivitis trials should be at least of 6 months duration and may be preventive or therapeutic in nature. The preferred statistical analysis when 2 treatments are being compared is a comparison of mean changes in plaque or gingivitis scores by the independent sample t-test. An analysis of covariance using the baseline scores as the covariate may improve power somewhat. When pairwise t-tests are performed in comparing several treatments, multiple comparison criteria are indicated. Parametric rather than nonparametric tests are preferred since they usually have more power. The square root of whole mouth means in gingivitis clinical trials is the preferred transformation to obtain greater power and to produce approximately normal distributions.     

Comparison of the effects of cetylpyridinium chloride with an essential oil mouth rinse on dental plaque and gingivitis - a six-month randomized controlled clinical trial

Objective: To compare the effects of an experimental mouth rinse containing 0.07% cetylpyridinium chloride (CPC) (Crest Pro‐Health^®) with those provided by a commercially available mouth rinse containing essential oils (EOs) (Listerine^®) on dental plaque accumulation and prevention of gingivitis in an unsupervised 6‐month randomized clinical trial. Material and Methods: This double‐blind, 6‐month, parallel group, positively controlled study involved 151 subjects balanced and randomly assigned to either positive control (EO) or experimental (CPC) mouth rinse treatment groups. At baseline, subjects received a dental prophylaxis procedure and began unsupervised rinsing twice a day with 20 ml of their assigned mouthwash for 30 s after brushing their teeth for 1 min. Subjects were assessed for gingivitis and gingival bleeding by the Gingival index (GI) of Löe & Silness (1963) and plaque by the Silness & Löe (1964) Plaque index at baseline and after 3 and 6 months of rinsing. At 3 and 6 months, oral soft tissue health was assessed. Microbiological samples were also taken for community profiling by the DNA checkerboard method. Results: Results show that after 3 and 6 months of rinsing, there were no significant differences (p=0.05) between the experimental (CPC) and the positive control mouth rinse treatment groups for overall gingivitis status, gingival bleeding, and plaque accumulation. At 6 months, the covariant (baseline) adjusted mean GI and bleeding sites percentages for the CPC and the EO rinses were 0.52 and 0.53 and 8.7 and 9.3, respectively. Both mouth rinses were well tolerated by the subjects. Microbiological community profiles were similar for the two treatment groups. Statistically, a significant greater reduction in bleeding sites was observed for the CPC rinse versus the EO rinse. Conclusion: The essential findings of this study indicated that there was no statistically significant difference in the anti‐plaque and anti‐gingivitis benefits between the experimental CPC mouth rinse and the positive control EO mouth rinse over a 6‐month period.     

Effect of two antibacterial mouth sprays and dentifrices on dental plaque and gingivitis in beagle dogs.

Plaque inhibition by dilute mouth sprays and dentrifrices containing benzethonium chloride and chlorhexidine gluconate was compared in beagle dogs. Agents with chlorhexidine gluconate produced less plaque than their benzethonium chloride or placebo counterparts, but the differences were not significant when compared to mean control scores registered during interexperimental recovery periods.     

Effectiveness of a triclosan/copolymer dentifrice on dental plaque and gingivitis in Brazilian individuais with cerebral palsy

This randomized clinicai trial investigated the effect of a dentifrice containing triclosan on the reduction of dental plaque and gingivitis in institutionalized individuais with cerebral palsy. Fifty-seven residents were randomly allocated to a test group (n=28, dentifrice with triclosan) and a control group (n=29. conventional dentifrice). A single calibrated investigator performed examinations at baseline and after three months. The amount of dental plaque was assessed, and gingivitis was meas-ured. The caretakers performed brushing with dentifrice. After three months, there was a significant reduction in the plaque index in both groups, but there was no difference between the two groups. There was a significant reduction in gingivitis only in the test group, and the difference between groups was significant after three months. The authors concluded that the dentifrice with triclosan reduced interdental bleeding in the studied population.     

Effect of triclosan/copolymer-containing toothpaste on the association between plaque and gingival bleeding: a randomized controlled clinical trial

AIM: To study longitudinal associations between plaque and gingival bleeding and multilevel variance/covariance structures after introducing triclosan-containing toothpaste. MATERIAL AND METHODS: A 10-week, randomized, two-arm, double-masked, controlled clinical trial was conducted in 34 healthy, non-smoking females with plaque-induced gingivitis. Clinical periodontal examinations were repeated every other week. At week 4, test toothpaste containing 0.24% sodium monofluorophosphate, 0.3% triclosan, and 2% polyvinyl-methyl ether maleic acid; or control toothpaste containing 0.76% sodium monofluorophosphate and 0.1% sodium fluoride, were randomly distributed. RESULTS: Multivariate multilevel models indicated that, after introducing experimental toothpastes, subject random error was reduced from 0.6 to below 0.2. The odds ratio (OR) of bleeding on probing (BOP) was about 30% less in the test than in the control group (p<0.01). At the end of the experiment, ORs for BOP and plaque index scores 1-3 (reference 0) were 2.1-2.4 in the control group, but 1.1-1.9 in the test group (p<0.05). No effects on plaque levels and calculus were observed. CONCLUSIONS: Multivariate multilevel modelling allows the study of fixed and random effects of experimental toothpastes on gingival inflammation in small sample. Triclosan appears to attenuate the causal association between supragingival plaque and gingival bleeding in gingivitis.     

Ingredients in dentifrices and their effect on plaque, gingivitis and mutans streptococci

Objective: The aim of this study was to investigate attitudes and opinions of old, independently living people about their oral health and how it has affected them through life. Material and methods: A random selection of 12 individuals was made in a group of 79 individuals who earlier participated in a study about self‐reported oral health. The average age was 78.4 years. An interview guide was used as support to focus on oral health. The respondents themselves decided what was important within the topics. The respondents were encouraged to speak freely about their childhood, family, social relations, memories from early dental care, general health situation, experience from health care, life and their future. The interviews were recorded and extended from 60 to 90 min. All of them were transcribed and analysed with phenomenological method inspired by Giogi. The analysis was made by two researchers independently. After 11 interviews, no new information was found; similar opinions, answers and stories recurred. Results: Seven of 11 respondents were born and grown up in the countryside and had moved to Stockholm in the forties. Awareness about dental care was generally low. Many of them have terrible memories from early dental visits, and the dentist was authoritarian and rough. Many had no memories of brushing their teeth as a child. Most of the respondents went to dentists as adults and when they could afford to pay by themselves. After retirement, all have continuous dental care and have visited a dental hygienist during the last 20 years. Nine of 11 have regular contact with a dental hygienist. Most of them are satisfied with their oral health and want to continue being clean and healthy in the mouth. Conclusions: Most of the respondents experienced an improved oral health, information and instructions from the dental hygienist have affected their self‐care. Many tell that they have become more aware and carry out the oral hygiene more carefully after retirement. All of them experience that oral health affects the quality of life.     

Effect of 3 dentifrices containing triclosan and various additives. An experimental gingivitis study

BACKGROUND: The antiplaque and antigingivitis effect of 3 dentifrices was evaluated using the 21-day partial-mouth experimental model of gingivitis. METHOD: 25 volunteers took part in this cross-over, double-blind study, carried out in 4 phases of 21 days each. For each phase of the study, a toothshield of the IV quadrant was constructed for each volunteer. 2 antiplaque dentifrices from the market, one containing triclosan + pvm/ma and the other triclosan + Zn, were compared with an experimental formulation and its placebo. The experimental dentifrice contained triclosan + pvm/ma + Zn + PPi and the placebo (control) did not contain these substances. The subjects were stratified according to their whole-mouth baseline plaque (PI), gingivitis (GI) and bleeding (BI) index scores, and then randomly assigned to 1 of 4 dentifrices. During each phase, while the volunteers brushed their teeth with one of the dentifrices, the IV quadrant was protected by the toothshield filled with the dentifrice used. After each phase, dental plaque, gingivitis and bleeding indices were determined. RESULTS: The results showed that only the formulation containing triclosan + pvm/ma + Zn + PPi was able to reduce PI (28.8%), GI (35.9%) and BI (30.4%) in comparison with controls (p<0.05). CONCLUSIONS: The data suggest that a dentifrice containing the combination of triclosan + pvm/ma + Zn + PPi should be formulated for dental plaque control.