A double-blind, randomised, 6-month clinical trial with parallel group design in 149 patients with gingivitis was conducted to study the efficacy and safety of delmopinol hydrochloride 2 mg/ml (0.2% w/v, Decapinol Mouthwash) used for partly supervised mouthrinsing in comparison with chlorhexidine digluconate 2 mg/ml (0.2% w/v, Hibitane Dental, ICI Pharmaceuticals, UK) and placebo as an addition to normal oral hygiene. Assessments of efficacy were performed using the plaque index and bleeding on probing (BOP). Delmopinol showed 22% lower plaque index scores than placebo after 3 months (p<0.01) and 13% lower scores after 6 months. The corresponding figures for chlorhexidine were 38% (p<0.001) and 38% (p<0.001) after 3 and 6 months, respectively. Bleeding on probing was reduced for delmopinol in comparison with placebo by 11% after 3 months and by 18% (p<0.05) after 6 months. For chlorhexidine the corresponding figures were 18% (p<0.01) and 22% (p<0.01) after 3 and 6 months, respectively. While chlorhexidine showed greater plaque reduction than delmopinol (p<0.01 at 6 months), no statistically significant difference was reached between these two solutions regarding BOP. Both active solutions showed an increased amount of dental calculus in comparison with placebo. A transient anaesthetic sensation in the oral mucosa and taste affection were commonly reported adverse events in both the delmopinol and the chlorhexidine groups. The number of patients withdrawn from treatment due to adverse events or lack of cooperation was 7 in the chlorhexidine group, 4 in the placebo group and 1 in the delmopinol group. The results showed that rinsing with either 0.2% delmopinol hydrochloride or 0.2% chlorhexidine digluconate twice daily for 60 secs for 6 months results in less plaque formation and gingivitis than rinsing with placebo. Mouthrinsing with the 0.2% delmopinol hydrochloride solution was well accepted in this study.
This double-blind, randomised, 6-month clinical trial with parallel group design in 68 subjects with gingivitis was conducted to study the effects on the oral flora of delmopinol hydrochloride 2 mg/ml (0.2% w/v, Decapinol Mouthwash), when used for partly supervised mouthrinsing in comparison with placebo and chlorhexidine digluconate 2 mg/ml (0.2% w/v, Hibitane Dental, ICI Pharmaceuticals, UK). Apart from estimating the total cultivable microbial dental plaque flora and salivary flora, analyses were focused on bacterial groups associated with gingivitis/periodontitis and dental caries. Furthermore, the presence of staphylococci, gram-negative enteric bacteria and yeasts in saliva were evaluated. The minimal inhibitory concentration (MIC) was determined for isolates belonging to the predominating micro-organisms in samples of both dental plaque and saliva. In relation to the findings in the placebo group, the use of delmopinol during the rinsing period did not produce an undesirable shift in the bacterial populations considered to be related to dental caries or periodontal diseases. These groups remained virtually unchanged during the study. In relation to the observations in the placebo group, slight reductions in the total cultivable plaque and salivary flora were observed during the study and no change was found in the ratio total anaerobically/aerobically cultivable microbial flora. Furthermore, no increased growth in staphylococci, enteric bacteria or yeasts was observed in the saliva samples. The pattern of changes taking place in the composition of the plaque and salivary microbial flora in samples from the participants rinsing with chlorhexidine were in most aspects similar to that observed in the delmopinol group. In the delmopinol group, no microbiologically significant changes were observed over time in the MIC-values for the isolates, neither in the plaque nor in the saliva samples, which indicates that no adaptation to delmopinol had taken place during the rinsing period. Similar observations were made for the plaque isolates in samples from the participants in the chlorhexidine group. On the other hand, when gram-positive and catalase-negative cocci from the saliva samples of the latter group were tested against chlorhexidine, 4-6 times higher MIC-values were obtained at 3 and 6 months both when compared to baseline and in comparison with the other two rinsing groups (p<0.01 or p<0.05). Neither delmopinol nor chlorhexidine showed any residual effect on the studied microbial groups in the plaque and the saliva samples 3 months after the end of treatment. In conclusion, delmopinol was accompanied by a composition of the plaque and salivary flora associated with healthy conditions in the oral cavity.
The aim of this short‐term study was to compare the effect of delmopinol HCl 0.2% and chlorhexidine digluconate 0.2% rinses on the development of dental plaque, the healing of experimental gingivitis, and the salivary microbiology. As part of a larger study protocol, 45 healthy males enrolled in an oral hygiene program to upgrade their oral health. For this portion of the study, participants had their teeth professionally cleaned on day 0. The participants then abstained from standard mechanical oral hygiene procedures, but applied a placebo solution twice daily for 2 weeks. At the end of this period the subjects received a second professional cleaning and were then assigned to 2 treatment groups: Group 1 rinsed with 10 ml of delmopinol HCl 0.2% and Group 2 rinsed with 10 ml of chlorhexidine digluconate 0.2% for 1 minute twice daily for the next 2 weeks and continued to refrain from mechanical oral hygiene procedures. At the end of the placebo and active treatment periods 1) saliva samples were taken and cultivated on a series of media; 2) the degree of gingivitis was assessed with gingival crevicular fluid (GCF) and gingivitis index (GI); and 3) the plaque index was assessed and the stainable buccal plaque extension was analyzed planimetrically. No changes in the salivary microbiological counts were detected for the subjects rinsing with delmopinol. Subjects rinsing with chlorhexidine showed significant reductions of anaerobes, aerobes, and S. mutans in saliva. The amounts of GCF and GI were reduced largely to the same extent in both treatment groups. Mean plaque extension was reduced by 52% after delmopinol and 88% after chlorhexidine rinsing. The results show that rinsing with delmopinol for a period of 14 days 1) does not give rise to detectable changes in the cultivable salivary microflora; 2) reduces plaque regrowth less effectively than chlorhexidine; and 3) promotes the healing of an experimentally induced gingivitis largely to the same extent as chlorhexidine. J Periodontol 1992; 63:618–625.
The aim of the present investigation was to study oral sugar clearance of various types of foodstuffs in children of different ages in comparison with adults. Thirty children and 20 adults were selected constituting five groups, each containing 10 individuals: 3-, 7-, 15-year-olds and adults, all with normal salivary secretion rate, and adults with low salivary secretion rate (dry mouth patients). Oral sugar clearance was studied using three glucose-containing products: solution, tablet and biscuit. Repeated saliva samples were collected every other minute, between 1 and 11 min after the intake, with a convenient method suitable for very young children. For that purpose, a small circular paper disc, absorbing approximately 20 μl of saliva, was placed under the tongue for 10 s. The glucose concentration of the samples was then analyzed enzymatically. The results showed that, in children, the oral sugar clearance became faster with increasing age. The adults and the 15-year-olds had similar patterns of clearance, while the dry mouth patients had the slowest oral clearance of all groups. The 3- and 7-year-olds showed the greatest variation in oral clearance between the various foodstuffs; the solution had faster clearance than both the biscuit and the tablet. The main conclusion from this study is that young children (3- and 7-year-olds) have both slower salivary sugar clearance and larger variation in clearance among various foodstuffs than older children and adults.
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