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Systemic corticosteroid therapy of oral vesiculoerosive diseases (OVED). An open trial.

BACKGROUND: We report the preliminary findings from our open study on how to optimize the doses and the response times to systemic corticosteroid therapy for three forms of oral vesiculoerosive diseases (OVED). METHODS: All twenty-one patients enrolled in the study were affected with OVED (10 OLP, 6 MMP, 5 EM) and received different doses of prednisone in relation to the type of disease and its severity. Daily mouthwashes with 0.12% chlorhexidine and application of miconazole gel were added to the therapy; its response time to treatment varied individually, the doses were reduced only after 75% of lesions had cleared. RESULTS: The average response time to treatment was 28 days. Clinical assessment showed that 95% of the patients had improved, whereas 71% had complete remission of oral signs and 48% experienced side effects. The degree of clinical resolution was: 70% complete remission after 26 days of therapy in patients with OLP, 33% complete remission after 38 days in patients with MMP, and 100% complete remission after ten days in patients with EM. CONCLUSIONS: Although a preliminary study, initial results showed different types and times of response to systemic corticosteroid treatment for the three diseases. Our findings strongly suggest that a unified therapeutic protocol for different OVED is not advisable, nor can systemic treatment be considered the first therapeutic approach.

Adolescent↗

GLOSSODYNIA.

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Anesthetics↗

Salivary gland cancer. A case-control investigation of risk factors.

Unlike most upper aerodigestive tract cancers, salivary gland cancers are relatively infrequent, are characterized by a diversity of histologic subtypes, and have never been etiologically associated with tobacco exposure. We present the results of a case-control study of risk factors for these cancers, with risk estimates derived from self-administered comprehensive risk-factor questionnaires distributed to patients at The University of Texas M. D. Anderson Cancer Center, Houston. Cases were 64 patients with histologically confirmed salivary gland cancer. Control subjects, randomly selected from the same patient population excluding patients with cancer of the head and neck or nonmelanoma skin cancer, were frequency-matched to the cases by age, sex, and ethnicity to achieve a 2:1 control subjects/cases ratio. On multivariate analysis, prior radiotherapy was a significant risk factor for both men (odds ratio [OR] = 2.1) and women (OR = 2.3). Among women, higher educational attainment (OR = 2.4), alcohol use (OR = 2.0), and hairdye use (OR = 2.5) were also significantly associated with risk. There were no significant differences between cases and control subjects with respect to tobacco exposure or specific occupational or leisure-time exposures. There is biological plausibility for associations with hairdye use and alcohol exposure.

Alcohol Drinking↗

Prevention of nosocomial infection in cardiac surgery by decontamination of the nasopharynx and oropharynx with chlorhexidine gluconate: a randomized controlled trial.

CONTEXT: Nosocomial infections are an important cause of morbidity and mortality after cardiac surgery. Decolonization of endogenous potential pathogenic microorganisms is important in the prevention of nosocomial infections. OBJECTIVE: To determine the efficacy of perioperative decontamination of the nasopharynx and oropharynx with 0.12% chlorhexidine gluconate for reduction of nosocomial infection after cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: A prospective, randomized, double-blind, placebo-controlled clinical trial conducted at the Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands, between August 1, 2003, and September 1, 2005. Of 991 patients older than 18 years undergoing elective cardiothoracic surgery during the study interval, 954 were eligible for analysis. INTERVENTION: Oropharyngeal rinse and nasal ointment containing either chlorhexidine gluconate or placebo. MAIN OUTCOME MEASURES: Incidence of nosocomial infection, in addition to the rate of Staphylococcus aureus nasal carriage and duration of hospital stay. RESULTS: The incidence of nosocomial infection in the chlorhexidine gluconate group and placebo group was 19.8% and 26.2%, respectively (absolute risk reduction [ARR], 6.4%; 95% confidence interval [CI], 1.1%-11.7%; P = .002). In particular, lower respiratory tract infections and deep surgical site infections were less common in the chlorhexidine gluconate group than in the placebo group (ARR, 6.5%; 95% CI, 2.3%-10.7%; P = .002; and 3.2%; 95% CI, 0.9%-5.5%; P = .002, respectively). For the prevention of 1 nosocomial infection, 16 patients needed to be treated with chlorhexidine gluconate. A significant reduction of 57.5% in S aureus nasal carriage was found in the chlorhexidine gluconate group compared with a reduction of 18.1% in the placebo group (P<.001). Total hospital stay for patients treated with chlorhexidine gluconate was 9.5 days compared with 10.3 days in the placebo group (ARR, 0.8 days; 95% CI, 0.24-1.88; P = .04). CONCLUSION: Decontamination of the nasopharynx and oropharynx with chlorhexidine gluconate appears to be an effective method to reduce nosocomial infection after cardiac surgery. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00272675.

Administration, Intranasal↗

Examination of the physical state of chlorhexidine within viscoelastic, bioadhesive semisolids using raman spectroscopy.

This study examined the effects of polymeric components on the physical state of chlorhexidine within bioadhesive, semisolid formulations using Raman spectroscopy. Semisolid formulations were prepared in which chlorhexidine base (CHX, 5%w/w, particle size <63 microm) was dispersed in aqueous (phosphate-buffered saline, pH 6.8) polymer matrices consisting of one or more polymeric components, namely HEC (3%w/w), PVP (3%), and PC (PC, 3%). Raman spectra were recorded using 785-nm excitation and were typically accumulated for 360 s. The Raman spectra were dominated by the presence of CHX. The spectra of CHX in HEC and in HEC/PVP gels were indistinguishable from that for solid CHX as a result of the insolubility of CHX in these formulations. However, in systems containing PC and CHX, there was a shift in the strongest band from 1564 cm(-1) to 1608 cm(-1), which may be accredited to protonation of the basic CHX by the numerous carboxylic acidic groups on PC. Identical shifts in the band positions were observed when this protonation was modeled using ethanoic acid, supporting the view that there was a simple acid base reaction between PC and CHX. However, there were notable differences in the relative intensities of the peaks from these samples, with the spectrum of CHX in the PC matrix displaying properties intermediate between those of CHX dissolved in ethanoic acid and solid CHX diacetate. This may be accredited to the limited solubility of the CHX-PC ion pair. In matrices containing HEC and PC, no peak was observed at 1564 cm(-1), whereas the intensity of the peak at 1608 cm(-1) was increased. Therefore, in these formulations CHX was completely converted to the di-cation as a result of the synergistic effects of PC (which protonated CHX) and HEC (which solubilized the di-cation). In the absence of either HEC or PC, complete protonation was not achieved. It is suggested that this enhancement of solubility of H(2)CHX(2+) may be due to hydrogen bonding, given the hydroxylated nature of HEC. In conclusion, this study has shown the applicability of Raman spectroscopy for both the analysis of opaque, semisolid formulations and, additionally, for the examination of the state of therapeutic agents within such matrices. In particular, using Raman spectroscopy, it was uniquely possible to identify the roles of various polymeric components on both the ionization and solubilization of CHX within aqueous semisolid systems.

Chemistry, Pharmaceutical↗

Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: Benzydamine was evaluated in patients with head and neck carcinoma for treatment of radiation-induced oral mucositis, a frequent complication of radiation therapy (RT) for which there is no predictable therapy or preventive treatment currently available. METHODS: The safety and efficacy of 0.15% benzydamine oral rinse in preventing or decreasing erythema, ulceration, and pain associated with oral mucositis during RT were evaluated in a randomized, placebo-controlled trial conducted in patients with head and neck carcinoma. Subjects were to rinse with 15 mL for 2 minutes, 4-8 times daily before and during RT, and for 2 weeks after completion of RT; study evaluations were conducted before RT and routinely thereafter up to 3 weeks after RT. RESULTS: During conventional RT, regimens up to cumulative doses of 5000 centigrays (cGy) benzydamine (n = 69) significantly (P = 0.006) reduced erythema and ulceration by approximately 30% compared with the placebo (n = 76); greater than 33% of benzydamine subjects remained ulcer free compared with 18% of placebo subjects (P = 0.037), and benzydamine significantly delayed the use of systemic analgesics compared with placebo (P < 0.05). Benzydamine was not effective in subjects (n = 20) receiving accelerated RT doses (> or = 220 cGy/day). The incidence of adverse events between treatment groups was comparable without significant differences. Early discontinuation because of adverse events occurred in 6% of benzydamine subjects and 5% of placebo subjects, and there was 1 death (related to the primary diagnosis) in a placebo subject. CONCLUSIONS: Benzydamine oral rinse was effective, safe, and well tolerated for prophylactic treatment of radiation-induced oral mucositis.

Adult↗

Fluoride mouthrinses for preventing dental caries in children and adolescents.

BACKGROUND: Fluoride mouthrinses have been used extensively as a caries-preventive intervention in school-based programmes and individually at home. OBJECTIVES: To determine the effectiveness and safety of fluoride mouthrinses in the prevention of dental caries in children and to examine factors potentially modifying their effect. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register (May 2000), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials with blind outcome assessment, comparing fluoride mouthrinse with placebo or no treatment in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). DATA COLLECTION AND ANALYSIS: Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in mean caries increments between the treatment and control groups expressed as a percentage of the mean increment in the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects metaregression analyses. MAIN RESULTS: Thirty-six studies were included. For the 34 that contributed data for meta-analysis (involving 14,600 children) the D(M)FS pooled PF was 26% (95% confidence interval (CI), 23% to 30%; p < 0.0001). Heterogeneity was not substantial, but confirmed statistically (p = 0.008). No significant association between estimates of D(M)FS prevented fractions and baseline caries severity, background exposure to fluorides, rinsing frequency and fluoride concentration was found in metaregression analyses. A funnel plot of the 34 studies indicated no relationship between prevented fraction and study precision. There is little information concerning possible adverse effects or acceptability of treatment in the included trials. REVIEWER'S CONCLUSIONS: This review suggests that the supervised regular use of fluoride mouthrinse at two main strengths and rinsing frequencies is associated with a clear reduction in caries increment in children. In populations with caries increment of 0.25 D(M)FS per year, 16 children will need to use a fluoride mouthrinse (rather than a non-fluoride rinse) to avoid one D(M)FS; in populations with a caries increment of 2.14 D(M)FS per year, 2 children will need to rinse to avoid one D(M)FS. There is a need for complete reporting of side effects and acceptability data in fluoride mouthrinse trials.

Adolescent↗

One topical fluoride (toothpastes, or mouthrinses, or gels, or varnishes) versus another for preventing dental caries in children and adolescents.

BACKGROUND: Topical fluorides in the form of toothpaste, mouthrinse, varnish and gel are effective caries preventive measures. However, there is uncertainty about the relative value of these interventions. OBJECTIVES: To compare the effectiveness of one form of topical fluoride intervention with another when used for the prevention of dental caries in children. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register (May 2000), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste with each other in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). DATA COLLECTION AND ANALYSIS: Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in mean caries increments between the 'experimental' and 'control' groups expressed as a percentage of the mean increment in the control group. Random effects meta-analyses were performed where data could be pooled. MAIN RESULTS: There were 17 studies included, and 15 contributed data for the meta-analyses. Fluoride toothpaste was not significantly different from mouthrinse (pooled DMFS PF 0%; 95% CI, -18% to 19%; p = 0.94), or gel (pooled DMFS PF 0%; 95% CI, -21% to 21%; p = 1), or both gel and mouthrinse (pooled DMFS PF 1%; 95% CI, -13% to 14%; p = 0.94); heterogeneity was substantial. Results from the single trial comparing toothpaste with varnish (in deciduous teeth) were inconclusive (dfs PF 5%; CI not obtainable). The pooled results from the comparisons of fluoride varnish with mouthrinse was a non-significant difference favouring varnish (DMFS PF 10%; 95% CI, -12% to 32%; p = 0.40), but this result was not robust to sensitivity analysis performed, and heterogeneity was considerable. Results from the single trial comparing varnish with gel (14%, 95% CI, -12% to 40%; p = 0.30) and the single trial comparing gel with mouthrinse (-14% DMFS PF; 95% CI, -40% to 12%; p = 0.30) were inconclusive (favoured varnish and mouthrinse respectively). REVIEWER'S CONCLUSIONS: Fluoride toothpastes in comparison to mouthrinses or gels appear to have a similar degree of effectiveness for the prevention of dental caries in children. There is no clear suggestion that fluoride varnish is more effective than mouthrinses and the evidence for the comparative effectiveness of fluoride varnishes and gels, and mouthrinses and gels is inconclusive. No conclusions about adverse effects could be reached, because no data were reported on in the trials. Acceptance is likely to be greater for fluoride toothpaste.

Adolescent↗