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Efficacy and tolerability of a new chlorhexidine-based vaginal gel in vaginal infections.

OBJECTIVE: We evaluated the efficacy and tolerability of a new chlorhexidine-based bioadhesive vaginal gel (Clomirex) in women with vaginal infections. STUDY DESIGN AND SUBJECTS: A total of 90 nonpregnant women with vaginal infections of both bacterial (bacterial vaginosis: BV) or fungal (vaginal candidiasis VC) origin, were enrolled in the study: a randomised, controlled, 4-week, multicentre trial. Patients were randomly treated with either chlorhexidine 0.5% vaginal gel (CHX-VG), 2.5 g or with metronidazole vaginal tablets 500 mg (M) or clotrimazole (CL) vaginal cream, depending on aetiology of the infection, daily for 7 days (treatment phase) in a 2:1 ratio. A total of 45 women had a diagnosis of BV and 45 a diagnosis of VC. Sixty women were treated with CHX-VG, 15 with M and 15 with CL. All patients were followed for an additional 3 weeks without treatments (follow-up phase). For women with BV,clinical cure rate was defined as the disappearance of the following signs and symptoms: homogenous vaginal discharge; presence of >or= 2 or more clue cells at the wet mount microscopy; a vaginal pH > 4.7 and a positive whiff test. For women with VC, clinical cure rate was defined as a resolution of signs and symptoms plus absence of hyphae, pseudohyphae and blastospores on 10% KOH wet mount microscopy. Clinical cure rate was assessed at the end of the study (week 4) by an investigator unaware of the patient's treatment allocation. RESULTS: At week 4, in women with BV, 28 out of 30 (93%) women in the CHX-VG group were clinically cured in comparison with 11 out of 15 (74%) in the M group (p = 0.3). In women with VC, 26 out of 30 (86.6%) women in the CHX-VG group were clinically cured in comparison with 13 out of 15 (86%) in the CL group (p = 0.5). Tolerability was good and very good in 90% of the CHX-VG patients. Six women (10%) complained of a mild transient burning sensation after CHX-VG vaginal application. No serious adverse events were observed during the trial in all treated groups. No women presented with vaginal discharge after treatment.

Adult↗

Chlorhexidine for prophylaxis against oral infections and associated complications in patients receiving bone marrow transplants.

Intensive chemoradiotherapy damages the mucosal barrier of the mouth and throat and is often associated with severe oral inflammation and infection. This study examined the use of a 0.12% chlorhexidine gluconate mouthrinse for prophylaxis against oral complications in patients receiving bone marrow transplants. Use of chlorhexidine mouthrinse produced reductions in oral soft tissue disease and oral microbial burden, including a significant decrease in oral mucositis and Candida infections. The advantage for patients undergoing intensive antineoplastic therapy, and potentially for other immunocompromised patients susceptible to oral infections, was studied.

Adolescent↗

Reducing bacterial aerosol contamination with a chlorhexidine gluconate pre-rinse.

The authors compared the effects of chlorhexidine gluconate, an antiseptic mouthwash with essential oils and water on the bacterial aerosol contamination generated by an air polishing device. Patients rinsed with one of the three solutions before treatment. Bacterial counts collected during the treatment indicate that the chlorhexidine pretreatment rinse was significantly more effective than the other solutions in reducing bacterial aerosols.

Adult↗

Effectiveness of rotary and hand files in gutta-percha and sealer removal using chloroform or chlorhexidine gel.

The purpose of this study was to assess in vitro the efficacy of nickel-titanium K3 rotary files and hand files for removal of gutta-percha and sealer from obturated root canals using either chloroform or chlorhexidine as solvents. Sixty extracted single-rooted bovine teeth with straight, large canals were prepared, obtured and randomly assigned to 3 groups (n=20). The teeth were stored at 37 degrees C for 1 month and then the gutta-percha and sealer were removed using different techniques, as follows. Group I: size 3 Gates-Glidden drills plus size 30 hand K-files and Hedström files and chloroform; Group II: K3 NiTi rotary files and chloroform; and Group III: K3 NiTi rotary files and 2% chlorhexidine gel. Radiographs were taken and scanned and the images were digitized. The total area of the canal and the area with remaining obturation material were measured in millimeters using a computed image analysis system (ImageLab). Data were analyzed statistically by one-way ANOVA and Tukey test at 5% significance level. The groups differed statistically (p<0.05) with respect to the average percentage of remaining gutta-percha and sealer, presenting the following sequence of effectiveness (from most to least effective): Group I (15.48%), Group II (28.42%) and Group III (35.96%). The findings of this study showed that, despite the technique used for removal of filling material, none of the retreated canals were completely free of gutta-percha and sealer remnants. The use of stainless steel hand files resulted in a lesser amount of filling debris than the use of nickel-titanium rotary instruments.

Animals↗

Effect of a 0.5% chlorhexidine gel on dental plaque superinfecting microorganisms in mentally handicapped patients.

A randomized clinical trial was conducted to investigate the effect of a 0.5% chlorhexidine (CHX) gel on dental plaque superinfecting microorganisms in mentally handicapped patients. Thirty inmates from the institution "Casas André Luiz" were assigned to either test group (CHX gel, n = 15) or control group (placebo gel, n = 15). The gel was administered over a period of 8 weeks. Supragingival plaque samples were collected at baseline, after gel use (8 weeks) and 16 weeks after baseline. The presence of Gram-negative Enterobacteriaceae, Staphylococcus and yeasts was evaluated. No significant growth of any superinfecting microorganism was observed in the CHX group, when compared to the placebo group. The results indicated that the 0.5% chlorhexidine gel did not produce an undesirable shift in these bacterial populations.

Adolescent↗

Influence of a chlorhexidine and a zinc mouthrinse on gingivitis.

The end point methodology did not indicate a difference between the agents. The prophylaxis effect was only demonstrable through 8 weeks, although the analysis of variance indicated a prophylaxis effect on gingival index throughout the study. An agent effect was not demonstrable in the study. The "positive control," chlorhexidine, did not give the same results in this brushing study as in previous no-brushing studies reported by Loe and by our group. One might conclude that the effectiveness of brushing in reducing gingivitis is greater than the effect of chlorhexidine. Decreasing plaque and gingivitis scores are seen with increasing time, probably reflecting increased subject interest and involvement in the study. Mere involvement in the study apparently produced a beneficial effect on gingival health. This "placebo effect" also has been noted in an earlier study. A similar decrease in plaque scores in a placebo group attributable to a general improvement of oral hygiene was reported by Gjermo and Rolla. The subjects who began the study with no calculus (prophylaxis group) had consistently lower calculus scores than those not given a prophylaxis. This difference became less distinct at later exams, as the treated group developed calculus. The agents, although ineffective under the test regimen produced no adverse effects.

Biguanides↗

A chlorhexidine-containing methacrylic gel as a periodontal dressing.

The modification of a methacrylic gel for use as a periodontal dressing was attempted. The increased adhesion and rigidity of the resultant material appeared consistent with the clinical findings. Satisfactory retention of the dressing was found in 85% of those placed on a group of patients attending for periodontal surgery. The potential value of the methacrylic gel for carrying and releasing pharmacological agents useful in the management of lesions of the oral mucosa was assessed by incorporating chlorhexidine acetate into the dressing. In vitro and in vivo studies demonstrated effective release of the chlorhexidine from the dressing throughout the period of time a periodontal dressing is normally in situ. In conclusion the results suggested that the modified methacrylic gel fulfills the requirements of a periodontal dressing. Study to assess further the potential for this material to carry other pharmacological agents used in the topical treatment of lesions of the oral mucosa is indicated.

Acrylates↗

An in vivo comparison of chlorhexidine and picloxydine mouthrinses: a possible association between chemical structure and antiplaque activity.

A double blind clinical trial was conducted in which both the plaque-inhibiting ability and the in vivo effects on the oral flora of chlorhexidine and picloxydine mouthwashes was compared. While picloxydine in higher concentration suppressed the oral flora more effectively than chlorhexidine, the latter agent inhibited plaque development to a much greater extent. This lack of correlation between antibacterial and antiplaque activity can be related to structural differences between these two bis-biguanides.

Bacteria↗

Effect of chlorhexidine on the hamster cheek pouch. Microcirculation and penetration studies.

The application of chlorhexidine gluconate on the intact cheek pouch of hamsters led to an immediate increase of flow velocity determined in venules beneath the epithelium. The application of [14C]chlorhexidine on the intact cheek pouch led to accumulation of labeled material in the liver and kidneys. Both findings indicate that penetration of the drug occurred through the epithelium of the cheek pouch.

Absorption↗

Chlorhexidine. An adjunct to periodontal therapy.

Chlorhexidine is an effective antimicrobial agent. Its application can enhance periodontal therapy. The pharmacology of chlorhexidine and suggestions for its use are outlined. In addition, its potential for inducing cancer and bacterial resistance are discussed.

Absorption↗

Postoperative pain and discomfort with and without periodontal dressing in conjunction with 0.2% chlorhexidine mouthwash after apically positioned flap procedure.

The purpose of this study was to evaluate patient postoperative pain experience and discomfort with and without the use of a periodontal dressing in combination with a 0.2% chlorhexidine mouthwash after internal bevelled, full thickness, apically positioned flap procedure. Twenty-four patients requiring comparable bilateral flap procedures were selected. Using a split-mouth design, one site received a periodontal dressing while the other site did not. A 0.2% chlorhexidine mouthwash (10 ml for 1 minute twice daily) was prescribed postoperatively for all patients. Pain assessment was made according to a structured, categorized scale (0 = no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain). Analgesic drug consumption was recorded during the first postoperative week. After at least a one-month period, the second flap procedure was performed using the alternate postoperative treatment. At the conclusion of the trial, a self-administered questionnaire on postoperative experience was administered. Results indicated a similar trend for mean pain scores as assessed by patients for both dressed and undressed sides during the 7-day postoperative period. Statistical analysis revealed no significant differences between treatment groups with respect to frequency distribution of patients who did or did not take analgesics or the daily and total consumption of analgesic drops. Although patients with dressing frequently experienced eating difficulty, most stated a psychological feeling of protection and well-being with its use.

Adult↗

Comparison of 2 commercially available chlorhexidine mouthrinses.

BACKGROUND: It has been shown that lowering the concentration of chlorhexidine (CHX) in mouthrinses from 0.2% to 0.12% does not adversely affect inhibition of plaque accumulation. The aim of this study was to evaluate the inhibition of plaque growth by 2 commercially available mouthrinses used according to the manufacturers' instructions, one with a 30-second and one with a 60-second rinsing time. METHODS: The clinical investigation was a single-blind, randomized study involving 80 volunteers (40 female, 40 male; mean age 25.7 years). At the start of the trial, all participants received a dental prophylaxis to remove all plaque deposits. Subjects refrained from all mechanical oral hygiene procedures, but rinsed twice a day with the allocated CHX mouthrinse over a period of 72 hours. The chlorhexidine preparations compared were a 0.12% concentration used at a 15 ml dose for a rinsing time of 30 seconds and a 0.2% concentration used at a dose of 10 ml for 60 seconds. After 72 hours, the plaque index (PI) from all volunteers was recorded at 6 sites per tooth. All participants received a questionnaire to evaluate their perception of the mouthrinses. RESULTS: After 72 hours, the 15 ml/30 second/0.12% CHX group had a mean whole mouth PI of 1.65 (SD 0.31) compared with a mean PI of 1.60 (SD 0.40) for the 10 ml/60 second/0.2% CHX group. The difference in plaque scores between the groups was not statistically significant. Results from the questionnaire showed no significant difference between the groups for taste perception, duration of taste, alteration in taste, or perceived plaque reduction; however, the panelists preferred the shorter rinsing time of 30 seconds and, for this parameter, the difference was statistically significant (P = 0.048). CONCLUSIONS: The results of this short-term study showed that there was no statistically significant difference between both commercially available CHX mouthrinses with respect to plaque inhibition, although both differed in concentration and rinsing time. The subject preference phase of the study indicated that the shorter rinsing time of 30 seconds was favored.

Adult↗

Efficacy of controlled-release subgingival chlorhexidine to enhance periodontal regeneration.

BACKGROUND: Periodontal regeneration success may be limited by placing bone grafts and membranes in infected sites. The objective of this study was to test the hypothesis that adjunctive subgingival administration of chlorhexidine gelatin bioresorbable chips enhances bone gain when used in conjunction with guided tissue regeneration. METHODS: This was a single center, blinded, 2-arm parallel design study of 44 subjects with one or more sites with probing depth and clinical attachment loss > or = 5 mm following initial therapy and radiographic evidence of bone loss. The patients were randomly assigned to receive either chlorhexidine (CHX) chip or sham chip placement one week prior to regenerative therapy that included graft placement and site coverage with guided tissue membranes. Patients also received CHX or sham chip placement, per their randomization, adjunctively to scaling and root planing or maintenance procedures. Periodontal examinations were completed at baseline (8 weeks prior to surgery); 1 week prior to surgery; and at 3, 6, and 9 months postsurgery. The major outcomes for the study were changes in bone height and bone mass as measured from standardized radiographs used for quantitative digital subtraction radiography over the 11-month study period. RESULTS: Subjects receiving sham chip placement gained a mean bone height of 1.49 +/- 0.22 mm, while patients receiving the CHX chips gained significantly more bone height (3.54 +/- 0.45 mm; P<0.001). Similarly, subjects receiving CHX chips as an adjunct gained significantly more bone mass (5.57 +/- 0.69 mg; P<0.001) than the standard therapy (2.59 +/- 0.34 mg). CONCLUSIONS: These pilot results indicate that locally delivered, controlled-release antimicrobial treatment may improve the amount of bone gain during guided tissue regeneration procedures. These data support the evidence that infection control is an important variable in successful regeneration.

Adult↗

Basic properties of an alginate impression material supplemented with chlorhexidine. I. Disinfectant effects on oral microbes.

To examine the disinfectant effects on oral microbes of an alginate impression material supplemented with 1% chlorhexidine as the aseptic ingredient (Coe Hydrophilic Gel, CHG), several cell suspensions of oral microbes (3 Gram-positives, 2 Gram-negatives and 1 yeast) were exposed to the surface of cast CHG or that of a control impression material for 5 or 30 min. They were then transferred to the surfaces of agar plates. Colony formation was estimated after culture for several incubation periods. No growth of bacteria on the plates was observed when the suspensions had been exposed to CHG even for 5 min, whereas for the control material, all the bacteria formed colonies. The yeast showed colony formation irrespective of the kind of impression material and the duration of exposure. Thus, it appears that use of an impression material supplemented with 1% chlorhexidine such as CHG may protect clinical staff and dental technicians from possible bacterial infections associated with the impression procedures.

Alginates↗

Effect of a Ca(OH)2 solution and a chlorhexidine based detergent on the microbial activity of human carious teeth.

Occlusar carious lesions from human molars, preserved in continuous humidity after extraction, were removed using conventional clinical techniques. Bacteriological samples were taken after rinsing the cavity with water only, after experimentally infecting the cavity and after treating uninfected cavities either with a saturated Ca(OH)2 solution or with a chlorhexidine based detergent. The samples were cultivated on blood agar plates aerobically and anaerobically. Cavities rinsed with water only showed very sparce bacterial growth. After experimental infection the growth was significant, but decreased radically after treatment with the test materials. In order to describe the effect of the two test materials on the microbial enzyme activity in infected dentin, cryostat sections of 10 micrometer were prepared from undermineralized carious dentin fragments excavated from freshly extracted human teeth. Conventional histochemical techniques were applied to demonstrate the aminopeptidase activity in the sections using N-L-leucyl-2-naphthylamide as a substrate. The aminopeptidase activity of carious dentin was inhibited totally with the Ca(OH)2 solution, whereas the chlorhexidine based detergent had no effect on the enzyme activity.

Aminopeptidases↗

Effects of polyhexamethylene biguanide and chlorhexidine on four species of Acanthamoeba in vitro.

We determined the relative minimal inhibitory and minimal amoebicidal concentrations of chlorhexidine digluconate and polyhexamethylene biguanide for four species of Acanthamoeba. The amoebae were grown in peptone-glucose-yeast extract broth for 72 h in tissue culture flasks. Either washed trophozoites (approximately 10(5)) or cysts (approximately 10(5)) were incubated in the enrichment broth in 96 well microtiter trays. Antimicrobial concentrations of the biguanides were determined from microscopic examinations of methylene blue uptake and from subcultures. In general, killing was time dependent. Minimal amoebicidal concentrations at 24 h ranged from 50 to 100 mg/ml and to as low as 25 mg/ml by 72 h. Trophozoites were killed more rapidly than cysts. Both biguanides had similar levels of activity. A synergistic combination of chlorhexidine and polyhexamethylene biguanide (total concentration 25 mg/ml) was most evident for A. castellanii and A. polyphaga. Cysts of A. culbertsoni and A. hatchetti stained more rapidly after exposure to the combination of biguanides than to the single biguanides, but there were no statistically significant differences in the final numbers of dead or stained cysts after exposure to the combination or to the single biguanides.

Acanthamoeba↗

Toxicity of chlorhexidine irrigation in chronic postpneumonectomy empyema.

Three patients with chronic Staphylococcus aureus empyema following pneumonectomy were treated with continuous chlorhexidine (0.02%) irrigation of the cavity. The empyema became sterile, but after a few days symptoms of cerebral intoxication appeared in all three patients. The symptoms resolved when the treatment was discontinued. Use of continuous chlorhexidine irrigation treatment of large wounds and cavities is therefore to be discouraged.

Chlorhexidine↗

Efficacies of teat germicides containing 0.5% chlorhexidine and 1% iodine during experimental challenge with Staphylococcus aureus and Streptococcus agalactiae.

Two germicides, one containing 0.5% chlorhexidine and one containing 1% iodine, were tested for efficacy against new intramammary infections (IMI) caused by Staphylococcus aureus and Streptococcus agalactiae. The model for the experimental challenge in the trials that were designed to test the efficacy of the two postmilking teat dips was recommended by the National Mastitis Council. The 0.5% chlorhexidine product reduced the number of new IMI caused by Staph. aureus by 73.2% and reduced the number of new IMI caused by Strep. agalactiae by 53.9%. The 1% iodine product reduced the number of new IMI caused by Staph. aureus by 75.6% and reduced the number of new IMI caused by Strep. agalactiae by 53.5%. In both trials, the incidence of clinical mastitis was also reduced in dipped quarters compared with control quarters. Use of the two teat dips over the trial periods had no effect on the condition of teat skin or teat ends.

Administration, Topical↗