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2.
Trials ; 19(1): 679, 2018 Dec 12.
Article in English | MEDLINE | ID: mdl-30541606

ABSTRACT

BACKGROUND: Lozenges containing lidocaine and cetylpyridinium chloride (CPC) are commonly used for the treatment of sore throat. The lidocaine acts locally to provide pain relief and the CPC has an antiseptic effect. Mebucaine CL, a well-established fixed-combination sore throat lozenge, contains 1 mg lidocaine and 2 mg CPC. Single-agent lozenges containing 8 mg lidocaine have also been demonstrated to be significantly superior to placebo in confirmatory pain intensity assessments. This study compared a new lozenge formulation, containing 8 mg lidocaine and 2 mg CPC, with the currently marketed lozenge for the treatment and relief of sore throat symptoms in subjects diagnosed with a sore throat due to an upper respiratory tract infection (URTI). METHODS: In this double-blind parallel-group study, 250 adults with a sore throat due to an URTI were randomized to receive a single lozenge containing either 8 mg lidocaine + 2 mg CPC (n = 125) or 1 mg lidocaine + 2 mg CPC (n = 125). The primary efficacy endpoint of the study was the change in sore throat pain intensity (STPI) between baseline (immediately pre-treatment) and the 2-h post-dose assessment, measured on a 100 mm visual analog scale. STPI was measured at baseline and regular intervals up to 240 min after the lozenge was administered (evaluated in clinic). Any difficulty in swallowing and time to onset and duration of the analgesic effect were also assessed. RESULTS: No increase in efficacy was demonstrated with the higher dose of lidocaine. The difference in the 2-h post-dose change in STPI was not statistically significant between the treatments. There was only one statistically significant difference between the treatments in all of the efficacy outcomes assessed: pain relief scores at 4 h post-dose were higher with 1 mg lidocaine + 2 mg CPC than with 8 mg lidocaine + 2 mg CPC (P = 0.0461). The most commonly reported adverse event (AE) was a headache; the only other AE experienced by more than one subject was throat irritation. No severe adverse events were reported during the assessment period. CONCLUSIONS: The modest difference in the pattern of effectiveness between the two treatments observed in this study does not support use of the 8 mg lidocaine + 2 mg CPC lozenge. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01265446 . Registered on 20 December 2010.


Subject(s)
Anesthetics, Local/administration & dosage , Anti-Infective Agents, Local/administration & dosage , Cetylpyridinium/administration & dosage , Lidocaine/administration & dosage , Pharyngitis/drug therapy , Respiratory Tract Infections/complications , Administration, Oral , Adult , Anesthetics, Local/adverse effects , Anti-Infective Agents, Local/adverse effects , Cetylpyridinium/adverse effects , Double-Blind Method , Drug Administration Schedule , Drug Combinations , Female , Germany , Humans , Lidocaine/adverse effects , Male , Pain Measurement , Pharyngitis/diagnosis , Pharyngitis/etiology , Respiratory Tract Infections/diagnosis , Time Factors , Treatment Outcome , Young Adult
3.
Gen Dent ; 66(3): 75-79, 2018.
Article in English | MEDLINE | ID: mdl-29714705

ABSTRACT

This in vitro study measured the pH values, titratable acidity (TA), and erosive potential of commercially available mouthrinses. A pH analysis of 6 mouthrinses (Listerine Total Care, Listerine Ultraclean, Listerine Original, Crest Pro-Health, Scope Classic, and ACT Total Care) was performed using a calibrated pH meter, and the neutralizable acidity was measured by titrating the mouthwashes against 0.1 M of sodium hydroxide. A gravimetric analysis was performed by submerging human enamel and dentin specimens in 5 mL of each mouthrinse for a total of 2 weeks. Specimens were weighed on a calibrated analytical balance at baseline, 24 hours, 48 hours, 96 hours, 1 week, and 2 weeks, and finally the loss of mass was calculated. The differences in erosive potential among the 6 mouthrinses were verified using nonparametric tests (Kruskal-Wallis and Mann- Whitney). The level of significance was set at 0.05. The mouthrinses were found to have the following mean pH/ TA values: Crest Pro-Health, 7.05/0.00; ACT Total Care, 6.31/5.44; Scope Classic, 5.18/0.42; Listerine Original, 3.98/9.26; Listerine Total Care, 3.43/5.88; and Listerine Ultraclean, 3.87/10.36. A significant correlation between pH and TA was observed for this dataset (P > 0.0001). No statistically significant difference in enamel loss among the groups was observed (P = 0.0631). However, a significant difference in dentin loss was observed among the 6 mouthrinses (P = 0.0011). Within the limitations of this in vitro study, it can be concluded that some mouthrinses have a pH lower than the critical pH of enamel and dentin. There is a significant association between acidic pH values and higher TA. Some of the tested mouthrinses presented an erosive potential on dentin.


Subject(s)
Dental Enamel/drug effects , Dentin/drug effects , Mouthwashes/adverse effects , Tooth Erosion/chemically induced , Cetylpyridinium/adverse effects , Drug Combinations , Humans , Hydrogen-Ion Concentration , In Vitro Techniques , Quaternary Ammonium Compounds/adverse effects , Salicylates/adverse effects , Terpenes/adverse effects
4.
Am J Dent ; 28 Spec No A: 4A-8A, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26591619

ABSTRACT

PURPOSE: To update the rationale for the use of mouthwashes and summarize data on the incorporation of an antibacterial, cetylpyridinium chloride (CPC), into a new mouthwash formulation. Data from various published articles are reviewed which demonstrate the value of mouthwashes. Also this Special Issue provides research supporting the efficacy of 0.075% cetylpyridinium chloride in a new, alcohol-free mouthwash formulation (Colgate Total). RESULTS: Benefits of mouthwashes include improving the reduction of plaque biofilm as an adjunct to oral hygiene, killing bacteria in areas difficult to reach by normal oral hygiene, killing bacteria on non-tooth oral surfaces, reaching bacteria subgingivally by placement in an irrigator, and supporting a positive effect on oral health by reducing bacteremia from oral micro-organisms. The benefits of including CPC in this new formulation are demonstrated by in vitro and clinical studies which demonstrate the efficacy of this formulation of CPC on biofilm as well as an effect on the reduction of plaque and gingivitis in three clinical studies.


Subject(s)
Anti-Bacterial Agents/pharmacology , Cetylpyridinium/pharmacology , Mouthwashes , Alcohols/analysis , Anti-Bacterial Agents/adverse effects , Biofilms , Cetylpyridinium/adverse effects , Dental Plaque , Humans , Mouth/microbiology
6.
Acta Odontol Scand ; 73(4): 267-73, 2015 May.
Article in English | MEDLINE | ID: mdl-25601200

ABSTRACT

OBJECTIVE: Polypharmacy is a common cause of xerostomia. This study aimed to investigate whether xerostomia could be an adverse drug event of mouthwashes, when they are used for longer than 2 weeks by patients taking polypharmacy. MATERIALS AND METHODS: This cross-sectional observational study included 120 hospitalized patients (60 middle-aged and 60 elderly patients), taking polypharmacy (≥4 drugs daily) and at risk of drug-induced xerostomia. Xerostomia was assessed by questioning participants. RESULTS: A total of 62.5% of patients complained of xerostomia. In the middle-aged group (mean age=44.0 (8.7) years; 35.0% women) xerostomia seemed independently associated to mouthwashes, at the limit of significance (OR=5.00, 95% CI=0.99-25.3, p=0.052). Active principles in mouthwashes were mainly quaternary ammonium compounds (91.9%). Mouthwashes may disturb the healthy balance of the biofilm moisturizing the oral mucosa. The biofilm contains mucins, salivary glycoproteins with oligosaccharides side chains able to sequester water and endogenous bacteria surrounded by a glycocalyx. Oral bacteria are fully susceptible to quaternary ammonium (chlorhexidine, hexetidine, cetylpyridinium chloride) and to other antiseptics used in mouthwashes, such as betain, resorcin, triclosan, essential oils and alcohol. However, caregivers currently recommend such dental plaque control products to patients suffering from xerostomia in order to reduce the risk of caries and periodontitis. CONCLUSION: This study is the first report that use of antiseptic mouthwashes for more than 2 weeks could worsen xerostomia in patients taking polypharmacy. Oral care protocols should avoid this iatrogenic practice, particularly when xerostomia alters the quality-of-life and worsens malnutrition.


Subject(s)
Anti-Infective Agents, Local/adverse effects , Mouthwashes/adverse effects , Polypharmacy , Xerostomia/chemically induced , Adult , Aged , Aged, 80 and over , Betaine/adverse effects , Biofilms/drug effects , Cetylpyridinium/adverse effects , Chlorhexidine/adverse effects , Cross-Sectional Studies , Dental Caries/prevention & control , Drug Interactions , Ethanol/adverse effects , Female , Hexetidine/adverse effects , Humans , Male , Middle Aged , Mouth/microbiology , Oils, Volatile/adverse effects , Periodontitis/prevention & control , Resorcinols/adverse effects , Triclosan/adverse effects
7.
Article in English | MEDLINE | ID: mdl-25482548

ABSTRACT

OBJECTIVE: To compare measures of dry mouth following extended use of an alcohol-based mouthrinse (LISTERINE Antiseptic [LA]) and a non-alcohol-based mouthrinse (Crest Pro-Health Rinse [CPH]) on healthy adults with "normal" salivary flow. METHODS: This single-site, randomized, observer-blinded, parallel study compared unstimulated whole salivary flow and perceived dryness following daily use at weeks 4 and 12 versus baseline. Noninferiority, between-treatment flow comparisons (0.15 mL/min margin), and between-treatment comparisons of the mean Bluestone Mouthfeel Questionnaire (BMQ) visual analog scale scores were made using analysis of covariance. RESULTS: Measures of dry mouth were comparable between mouthrinses, as demonstrated by both noninferiority of LA versus CPH flow (P < .001) and no significant differences between groups in the BMQ measures at 4 or 12 weeks. CONCLUSIONS: Extended use of an alcohol-based mouthrinse is no more likely to cause reduction in salivary flow or perceived dryness in individuals with normal salivary flow compared with a non-alcohol-based mouthrinse (CPH).


Subject(s)
Cetylpyridinium/adverse effects , Mouthwashes/adverse effects , Salicylates/adverse effects , Salivation/drug effects , Terpenes/adverse effects , Xerostomia/chemically induced , Adult , Drug Combinations , Female , Humans , Male , Surveys and Questionnaires
8.
Am J Dent ; 27(3): 119-26, 2014 Jun.
Article in English | MEDLINE | ID: mdl-25208357

ABSTRACT

PURPOSE: This randomized, single center, examiner-blind, controlled, parallel-group, 6-month clinical study compared the antiplaque/antigingivitis potential of an essential oil (EO) versus a 0.07% cetylpyridinium chloride (CPC)-containing mouthrinse. A 5% hydroalcohol solution was included as a control group. METHODS: 354 healthy volunteers (18-71 years of age) were enrolled in this clinical trial; 338 subjects completed the study. At baseline, 1-, 3-, and 6-month visits, subjects received an oral examination, gingivitis (MGI), gingival bleeding (BI) and plaque assessments (PI). Following randomization, subjects received a prophylaxis and began brushing twice daily with the provided fluoride toothpaste and rinsing twice daily with 20 mL of the assigned mouthrinse for 30 seconds. RESULTS: All rinses were well tolerated by the subjects, with the exception of extrinsic tooth stain complaints in 13 subjects in the CPC group between the 3- and 6-month exams. Statistically significant reductions in gingivitis, bleeding and plaque were observed for both EO and CPC at all post-baseline time-points when compared to the negative control. At 6 months MGI and PI were reduced by 42.6% and 42.0% for EO and by 17.1% and 13.9% respectively, for CPC vs. control. When compared to CPC, EO was statistically significantly superior at all post-baseline time-points. EO showed increasing reductions in MGI of 10.5%, 20.3% and 30.7% as well as reductions in PI of 12.7%, 23.7% and 32.6% at 1, 3 and 6 months, respectively. When analyzing the number of healthy sites (MGI scores of 0 or 1), the beneficial effect of the EO-containing mouthrinse is 45.8% greater than using a CPC-containing mouthrinse and 59.8% greater than placebo.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Cetylpyridinium/therapeutic use , Gingivitis/prevention & control , Mouthwashes/therapeutic use , Oils, Volatile/therapeutic use , Adolescent , Adult , Aged , Anti-Infective Agents, Local/adverse effects , Cetylpyridinium/adverse effects , Dental Plaque/prevention & control , Dental Plaque Index , Drug Combinations , Female , Follow-Up Studies , Gingival Hemorrhage/prevention & control , Humans , Male , Middle Aged , Mouthwashes/adverse effects , Periodontal Index , Placebos , Salicylates/therapeutic use , Single-Blind Method , Terpenes/therapeutic use , Tooth Discoloration/chemically induced , Young Adult
9.
J Clin Dent ; 24(1): 5-11, 2013.
Article in English | MEDLINE | ID: mdl-23547488

ABSTRACT

OBJECTIVES: The objectives of this clinical trial were to determine the tooth staining potential as measured by the Macpherson Modification of the Lobene Stain Index, and degree of taste alteration of four currently marketed mouthrinses when used over a 12-week period. METHODS: This investigation consisted of a 12-week, observer-blind, single-center, randomized comparison of five parallel groups of subjects. One-hundred and seventy-one subjects granting their informed consent completed the trial. Subjects were randomized to one of four currently marketed mouthrinses Crest PRO-HEALTH Rinse (CPH), Cepacol (C), Scope (S), Viadent ADVANCED CARE (V), or brushing alone (BA) with a currently marketed fluoride toothpaste. Upon randomization, subjects received a baseline stain score and then a prophylaxis to remove all extrinsic stain. Clinical assessments were repeated after six weeks and three months of product use, and subjects were asked to complete a questionnaire after the first use, at day 4, day 14, at six weeks, and 12 weeks to assess potential taste alteration. RESULTS: CPH and C demonstrated significantly (p < 0.001) more extrinsic stain after six weeks of use, and CPH, C (p < 0.001), and S (p = 0.01) after 12 weeks of use versus brushing alone with fluoride toothpaste. V was not significantly different from brushing alone at either time point. After six weeks of using the product as directed, up to 53% of subjects using CPH experienced taste interference for up to three hours post-rinse. CONCLUSIONS: The results of this study demonstrated that regular use of CPH and C mouthrinses resulted in extrinsic stain accumulation after six weeks, with increased accumulation after 12 weeks versus brushing alone.


Subject(s)
Anti-Infective Agents, Local/adverse effects , Cetylpyridinium/adverse effects , Mouthwashes/adverse effects , Tooth Discoloration/chemically induced , Adult , Benzophenanthridines/adverse effects , Cariostatic Agents/therapeutic use , Drug Combinations , Fluorides/therapeutic use , Follow-Up Studies , Humans , Isoquinolines/adverse effects , Quaternary Ammonium Compounds/adverse effects , Single-Blind Method , Taste/drug effects , Taste Disorders/chemically induced , Time Factors , Toothbrushing
10.
Contact Dermatitis ; 68(2): 103-10, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23206313

ABSTRACT

BACKGROUND: An increased frequency of occupational contact hand dermatitis among surgical operating theatre personnel has been noticed. OBJECTIVES: To evaluate patients with occupational contact dermatitis caused by their rubber gloves, and to describe a method for analysing the content of the allergens in the gloves. MATERIALS AND METHODS: Patch tests were performed with the baseline series, a rubber chemical series, and the patients' own gloves. A method for analysing 1,3-diphenylguanidine (DPG) and cetylpyridinium chloride in the gloves was developed. RESULTS: Contact allergy to thiuram mix was found in 8 of 16 patients, whereas 12 of 16 patients reacted to DPG. In 7 of 8 patients, contact allergy to cetylpyridinium chloride was found. In the patients' gloves, cetylpyridinium chloride and DPG were detected at higher concentrations on the inside of the gloves than on the outside. Most patients had worked for decades in their present occupations, but their hand dermatitis had only been present for months. CONCLUSION: Contact allergy to DPG in gloves has been disputed, but, in this study, we were able to confirm the presence of DPG and cetylpyridinium chloride in the causative gloves by using a modified method for the analysis. The presence of these chemicals in gloves caused an increase in occupational contact dermatitis in surgical operating theatre personnel.


Subject(s)
Anti-Infective Agents, Local/adverse effects , Cetylpyridinium/adverse effects , Gloves, Surgical/adverse effects , Guanidines/adverse effects , Thiram/adverse effects , Adult , Chromatography, High Pressure Liquid , Dermatitis, Allergic Contact/diagnosis , Dermatitis, Allergic Contact/etiology , Dermatitis, Occupational/diagnosis , Dermatitis, Occupational/etiology , Female , Hand Dermatoses/diagnosis , Hand Dermatoses/etiology , Humans , Male , Middle Aged , Patch Tests
12.
Clin Ther ; 31(11): 2540-8, 2009 Nov.
Article in English | MEDLINE | ID: mdl-20109998

ABSTRACT

BACKGROUND: Studies with cetylpyridinium chloride (CPC) mouth rinses that range from 1 use to 6 months of use have documented the clinical efficacy of these formulations on supragingival plaque and gingivitis. OBJECTIVE: The objective of the present study was to compare the effects of a commercially available mouth rinse containing 0.05% CPC versus a fluoride mouth rinse on the anaerobic bacteria found in dental plaque. Antimicrobial effects on the organisms of the supragingival plaque, a natural biofilm, were determined after 1 use and after 14 days of use of each mouth rinse. METHODS: After enrollment, adult subjects from China completed a 1-week washout period and provided baseline samples of supragingival plaque for analysis of anaerobic bacteria. Subjects were randomly assigned to receive a commercially available mouth rinse formulated with 0.05% CPC or a fluoride mouth rinse. Subjects were assigned to each group according to a computer-generated randomization sequence. They were instructed to rinse with 20 mL of either the CPC or the fluoride mouth rinse for 30 seconds. Microbiologic analyses of dental plaque samples were conducted 12 hours after the first use of assigned mouth rinse. Subjects were instructed to continue twice-daily rinsing with their assigned mouth rinse for the next 14 days in addition to brushing their teeth with a commercial fluoride toothpaste. Dental plaque samples for microbiologic analyses were collected on day 15; this was done 12 hours after the final use of the assigned mouth rinses. A dentist conducted oral examinations before each sample collection to evaluate hard and soft tissue health over the course of the study. RESULTS: The study included 117 adults (62 females, mean age, 28.70 years; 55 males, mean age, 30.41 years). Subjects rinsing with the CPC mouthwash (n = 58; mean age, 29.41 years) reported significant reductions in anaerobic bacteria versus those issued the fluoride rinse (n = 59; mean age, 29.61 years) 12 hours after 1 use and 12 hours after 14 days of use (P < 0.001). The mean percent reduction in anaerobic bacteria between the CPC mouth rinse and the fluoride mouth rinse was 29.98% after 1 use and 57.90% after 14 days of use. All enrolled subjects completed the study without any adverse events. CONCLUSION: Use of the CPC mouth rinse was associated with significant reductions in the anaerobic bacteria of supragingival plaque compared with fluoride mouth rinse use in these adult subjects.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Cariostatic Agents/therapeutic use , Cetylpyridinium/therapeutic use , Dental Plaque/drug therapy , Dental Plaque/microbiology , Mouthwashes , Adolescent , Adult , Aged, 80 and over , Anti-Infective Agents, Local/administration & dosage , Anti-Infective Agents, Local/adverse effects , Bacteria, Anaerobic/drug effects , Cariostatic Agents/administration & dosage , Cariostatic Agents/adverse effects , Cetylpyridinium/administration & dosage , Cetylpyridinium/adverse effects , Colony Count, Microbial , Double-Blind Method , Female , Fluorides/administration & dosage , Fluorides/therapeutic use , Gingiva/microbiology , Humans , Male , Middle Aged , Young Adult
13.
J Periodontol ; 77(2): 248-56, 2006 Feb.
Article in English | MEDLINE | ID: mdl-16460251

ABSTRACT

BACKGROUND: Due to the side effects of chlorhexidine digluconate (CHX) mouthrinsing, a spray has been proposed as an alternative method of CHX delivery to the oral cavity. The aim of this study was to investigate the plaque inhibitory effects of CHX, cetylpyridinium chloride (CPC), and triclosan (TRN) delivered by sprays and mouthrinses. METHODS: The study was an observer-masked, randomized cross-over design balanced for carryover effects, involving 15 healthy volunteers in a 4-day plaque regrowth model. Products being tested (0.2% CHX, 0.12% CHX, 0.05% CPC, and 0.03% TRN) were used both as sprays and mouthrinses. A saline solution served as a negative control. On day 1, subjects received professional prophylaxis, suspended oral hygiene measures, and commenced using their allocated products. On day 5, subjects were scored for disclosed plaque. RESULTS: CHX sprays (P<0.01) were the most effective sprays in preventing plaque regrowth, without significant differences between the two concentrations tested (P>0.05). TRN spray showed a significant inhibition of plaque regrowth in comparison to the negative control (P<0.05). CPC spray did not differ from saline spray (P>0.05). A similar trend of efficacy was detected for rinses. Although the effect on plaque regrowth observed with CHX rinses was superior to that of CHX sprays (P<0.0003), the latter did not cause side effects (P>0.2). CONCLUSIONS: These findings, together with those from clinical trials, suggest that the CHX-containing sprays may represent an effective alternative to CHX rinses when mechanical oral hygiene has to be avoided in restricted areas. On the contrary, the TRN and CPC sprays showed little or no plaque inhibitory effects.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Cetylpyridinium/administration & dosage , Chlorhexidine/analogs & derivatives , Dental Plaque/prevention & control , Mouthwashes/administration & dosage , Triclosan/administration & dosage , Adult , Aerosols , Anti-Infective Agents, Local/adverse effects , Cetylpyridinium/adverse effects , Chlorhexidine/administration & dosage , Chlorhexidine/adverse effects , Coloring Agents , Cross-Over Studies , Dental Plaque/pathology , Dental Prophylaxis , Female , Humans , Male , Mouthwashes/adverse effects , Observer Variation , Oral Hygiene , Reproducibility of Results , Single-Blind Method , Sodium Chloride , Triclosan/adverse effects
14.
Am J Dent ; 18 Spec No: 29A-34A, 2005 Jul.
Article in English | MEDLINE | ID: mdl-16178134

ABSTRACT

PURPOSE: Behavioral research was conducted to ascertain the relevance of an alcohol-free, 0.07% cetylpyridinium chloride (CPC) therapeutic mouthrinse to contemporary dental practice over a 6-month usage period. METHODS: A randomized, single-blind study was conducted to assess practice-relevant compliance, acceptability and side effects associated with two mouthrinses. The target population was healthy adult mouthrinse users with a history of routine dental prophylaxis and maintenance care. Subjects were randomly assigned to a therapeutic mouthrinse with 0.07% CPC (Crest Pro-Health Rinse) or a cosmetic rinse control (Scope). Other oral hygiene was not standardized. Subjects completed a questionnaire and were examined by dental hygienists at baseline, and again after 3 and 6 months rinsing. At study completion, a dental prophylaxis was administered. RESULTS: Compliance was generally favorable, with 273 subjects (89%) completing the 6-month rinsing study. Rinsing time generally stayed the same or increased relative to baseline. Groups differed among the subset who historically used an essential oils rinse (N=137), where those assigned to the alcohol-free therapeutic rinse exhibited significantly (P= 0.02) longer rinsing times compared to subjects using the alcohol-containing cosmetic rinse. Subject evaluations were generally positive with respect to both rinses. Side effects were minimal, with no between-group differences in hygienist-rated calculus or stain accumulation, or prophylaxis time. CLINICAL SIGNIFICANCE: In a 6-month study, a high bioavailable 0.07% CPC therapeutic mouthrinse showed generally high compliance and favorable user acceptability, with similar side effects to those seen with a cosmetic mouthrinse. These findings suggest that the 0.07% CPC mouthrinse may be readily incorporated within the contemporary recall dental practice.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Cetylpyridinium/therapeutic use , Mouthwashes/therapeutic use , Patient Compliance , Adolescent , Adult , Aged , Anti-Infective Agents, Local/adverse effects , Cetylpyridinium/adverse effects , Dental Calculus/classification , Dental Prophylaxis , Drug Combinations , Follow-Up Studies , Humans , Middle Aged , Mouthwashes/adverse effects , Oral Hygiene , Patient Satisfaction , Quaternary Ammonium Compounds/therapeutic use , Time Factors , Tooth Discoloration/classification
15.
J Clin Periodontol ; 32(6): 595-603, 2005 Jun.
Article in English | MEDLINE | ID: mdl-15882217

ABSTRACT

OBJECTIVE: To evaluate the effect of a mouth-rinse formulation combining benzydamine hydrochloride and cetylpyridinium chloride (BNZ+CPC) in preventing de novo plaque formation, in comparison with CPC and placebo mouth rinses. PATIENTS AND METHODS: This was a controlled, observer-blind, cross-over study. In this model of plaque re-growth, subjects received a session of oral prophylaxis and were directed to withdraw oral hygiene measures for the next 4 days, using only the mouth rinse assigned. The outcome parameters were the plaque index (PlI) and gingival index (GI). In addition, microbiological evaluation of the subgingival microflora, by means of culture, was performed, as well as patient-based variables. Data analysis was carried out using anova for Latin-square design. RESULTS: The analysis of variance showed a significant statistical difference between the BNZ+CPC association and placebo (p<0.0001). No differences between CPC and placebo were detected considering multiple comparisons between treatments. The 90% confidence interval of the differences between BNZ+CPC and CPC showed no equivalence between treatments, being the PlI lower in the BNZ+CPC group. No significant difference between groups in GI was observed. Mean anaerobic colony-forming units (CFU) demonstrated a significant increase between visits in all groups (p<0.001) and differences among groups were not significant. Subjects treated with BNZ+CPC frequently reported "tingling mouth" and "numbness mouth". CONCLUSION: Within the limitations of the study model, the BNZ+CPC combination showed a statistically significant plaque-inhibitory capacity, as compared with the placebo mouth rinse, and an additive effect as compared with CPC. No relevant clinical or microbiological adverse effects were detected.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Anti-Inflammatory Agents/therapeutic use , Benzydamine/therapeutic use , Cetylpyridinium/therapeutic use , Dental Plaque/drug therapy , Mouthwashes/therapeutic use , Adolescent , Adult , Analysis of Variance , Anti-Infective Agents, Local/adverse effects , Anti-Inflammatory Agents/adverse effects , Benzydamine/adverse effects , Cetylpyridinium/adverse effects , Cross-Over Studies , Dental Plaque/microbiology , Dental Plaque/prevention & control , Dental Plaque Index , Drug Combinations , Female , Humans , Male , Mouthwashes/adverse effects , Periodontal Index
16.
J Clin Periodontol ; 32(4): 390-400, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15811057

ABSTRACT

BACKGROUND: Chlorhexidine (CHX) mouth rinse/spray can still be considered the gold standard in the chemical prevention of plaque formation and development of gingivitis. The product unfortunately has some side effects, such as extrinsic tooth staining, poor taste, taste disturbance, sensitivity changes in tongue, pain and irritation because of the alcohol content. These side effects led to the search of new formulations. METHODS: In this double-blind, randomized, long-term, parallel study, 48 moderate periodontitis patients rinsed for 6 months (starting immediately after a "one-stage, full-mouth" disinfection) with one of the following products: CHX 0.2%+alcohol (Corsodyl), CHX 0.05%+ cetyl pyridinium chloride (CPC) 0.05% and no alcohol (Perio-Aid Maintenance, a new formulation), or the placebo of the latter. After 1, 3 and 6 months a series of clinical and microbiological parameters were recorded for the supra- and subgingival area as well as for saliva. RESULTS: Although there was a significant treatment impact (mechanical debridement) in all groups, both CHX solutions further decreased both plaque and gingivitis indices (p<0.001 and p<0.05, respectively), when compared with placebo. This was also reflected by additional reductions in the number of CFU/ml of aerobic and especially anaerobic species and by a suppression of Streptococcus mutans (versus an overgrowth for the placebo), in all niches. Differences between both CHX solutions were never encountered. The subjective ratings were slightly in favour of the new CHX-CPC formulation when compared with the other CHX-alcohol formulation, especially for taste of the product (p<0.05), but less impressive for the staining of teeth and tongue. CONCLUSIONS: The results of this study demonstrated the potential of a new CHX 0.05%+CPC 0.05% non-alcoholic formulation as an effective antiplaque agent for long-term use with reduced subjective side effects.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Cetylpyridinium/administration & dosage , Chlorhexidine/administration & dosage , Dental Prophylaxis/methods , Mouthwashes/administration & dosage , Periodontitis/prevention & control , Bacteria, Anaerobic/drug effects , Cetylpyridinium/adverse effects , Chlorhexidine/adverse effects , Dental Plaque/prevention & control , Dental Plaque Index , Double-Blind Method , Drug Combinations , Female , Humans , Male , Middle Aged , Periodontal Index , Taste , Tooth Discoloration/chemically induced
17.
Shanghai Kou Qiang Yi Xue ; 12(6): 414-8, 2003 Dec.
Article in Chinese | MEDLINE | ID: mdl-14966578

ABSTRACT

OBJECTIVE: To investigate the clinical effect of a 0.1% cetylpyridinium chloride(CPC) rinse on the treatment of gingivitis and periodontitis. METHODS: A multicenter, randomized, parallel group trial was conducted. The eligible patients were divided randomly into two groups. Subjects were assessed at the beginning and the end of a two-week period during which they rinsed with 0.1% CPC or complex hibitane in addition to their usual oral hygiene procedures. The variation of PLI, SBI, GI, PD, pain, halitosis and adverse effects were observed before and after investigation. RESULTS: After 14 days of treatment, in the CPC group, the decreasing rate of PLI was 63.0%, the effective rate for gingivitis and periodontitis were 83.3%, 36.7% respectively, while those periodontal indices of control group were 49.5%, 50% and 16.7%. After statistical analysis, the CPC group had significantly higher effective rates on gingivitis than the hibitane group (P < 0.01), at the same time, the effective rate was significantly different between two groups on periodontitis (P < 0.05). CONCLUSION: The use of 0.1% CPC rinse is effective in treating periodontal diseases.


Subject(s)
Cetylpyridinium/administration & dosage , Gingivitis/drug therapy , Mouthwashes , Periodontitis/drug therapy , Adolescent , Adult , Aged , Cetylpyridinium/adverse effects , Dental Plaque/prevention & control , Female , Humans , Male , Middle Aged
19.
Boll Chim Farm ; 136(7): 543-8, 1997.
Article in English | MEDLINE | ID: mdl-9432193

ABSTRACT

A buccoadhesive slow-release system constituted by a monolayer tablet was developed for the administration of cetylpyridinium chloride (CPC). Tablet composition was based on a mixture of a bioadhesive polymer with conventional excipients. Three different polymers (Methocel K4M, Noveon AA1, Carbopol 974P) in three different concentrations (10%, 20%, 30%) were used. The release profile and the adhesion properties of nine formulations were evaluated in vitro. Based on these results three formulations containing 10% w/w of the tested polymers were chosen to assess, with preliminary in vivo studies, the compliance and the residence time in the month of the systems. Tablets containing Noveon AA1 showed the best performances.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Cetylpyridinium/administration & dosage , Adult , Anti-Infective Agents, Local/adverse effects , Anti-Infective Agents, Local/pharmacokinetics , Cetylpyridinium/adverse effects , Cetylpyridinium/pharmacokinetics , Female , Humans , Male , Middle Aged , Tablets , Tissue Adhesions
20.
J Clin Periodontol ; 22(11): 824-9, 1995 Nov.
Article in English | MEDLINE | ID: mdl-8550857

ABSTRACT

To evaluate the relative efficacy of a non-degradable osmotic slow-release dosage form containing 6.6 mg cetylpyridinium chloride (MOTS [Mucosal Oral Therapeutic System] CPC) to inhibit new plaque formation and gingivitis, a single-blind, randomised, parallel group pilot study was set up. 52 healthy volunteers were assigned to receive one of the following treatments for 18 days of non-brushing: holding 1 MOTS CPC 2 x daily for 2 h intra-orally, or rinsing 30 s with 15 ml Peridex 2 x daily, or dissolve Cepacol (each 1.6 mg CPC) lozenges 2 x daily unsupervised. Before the test period, the subjects received a thorough tooth cleaning followed by tooth polishing 1 x a week for 3 weeks to achieve clinical gingival health. After the start of therapy, the subjects were examined at day 4, 7 (+/- 2), 14 (+/- 2) and 18 (2 +/-). Relative efficacy was assessed by the modified Navy plaque index, the Quigley and Hein index, the planimetric plaque index, as well as the papillary marginal gingival index. There was an increase in both plaque formation and gingivitis over the 18 +/- 2 day period of nonbrushing for all subjects in the study. Peridex was the most effective in inhibiting plaque and gingivitis formation over that period of time. There was no difference between MOTS CPC and Cepacol at any time point in plaque accumulation and gingivitis intensity. Peridex was considered more convenient than MOTS CPC. Cepacol resulted in more staining at 18 days than MOTS CPC and Peridex.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Cetylpyridinium/therapeutic use , Dental Plaque/prevention & control , Adolescent , Adult , Anti-Infective Agents, Local/administration & dosage , Anti-Infective Agents, Local/adverse effects , Cetylpyridinium/administration & dosage , Cetylpyridinium/adverse effects , Chlorhexidine/administration & dosage , Chlorhexidine/adverse effects , Chlorhexidine/analogs & derivatives , Chlorhexidine/therapeutic use , Delayed-Action Preparations , Dental Plaque/microbiology , Dental Plaque Index , Dental Prophylaxis , Drug Tolerance , Female , Gingivitis/prevention & control , Humans , Male , Mouthwashes , Periodontal Index , Pilot Projects , Single-Blind Method , Tablets
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