6-MONTH USE OF 0.2-PERCENT DELMOPINOL HYDROCHLORIDE IN COMPARISON WITH 0.2-PERCENT CHLORHEXIDINE DIGLUCONATE AND PLACEBO - (II) - EFFECT ONPLAQUE AND SALIVARY MICROFLORA

This double-blind, randomised, 6-month clinical trial with parallel gr oup design in 68 subjects with gingivitis was conducted to study the e ffects on the oral flora of delmopinol hydrochloride 2 mg/ml (0.2% w/v , Decapinol Mouthwash), when used for partly supervised mouthrinsing i n 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 staphylo cocci, Gram-negative enteric bacteria and yeasts in saliva were evalua ted. The minimal inhibitory concentration (MIC) was determined for iso lates belonging to the predominating micro-organisms in samples of bot h dental plaque and saliva. In relation to the findings in the placebo group, the use of delmopinol during the rinsing period did not produc e an undesirable shift in the bacterial populations considered to be r elated 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 plaqu e and salivary flora were observed during the study and no change was found in the ratio total anaerobically/aerobically cultivable microbia l flora. Furthermore, no increased growth in staphylococci, enteric ba cteria or yeasts was observed in the saliva samples. The pattern of ch anges taking place in the composition of the plaque and salivary micro bial 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 we re observed over time in the MIG-values for the isolates, neither in t he plaque nor in the saliva samples, which indicates that no adaptatio n to delmopinol had taken place during the rinsing period. Similar obs ervations were made for the plaque isolates in samples from the partic ipants in the chlorhexidine group. On the other hand, when Gram-positi ve and catalase-negative cocci from the saliva samples of the latter g roup were tested against chlorhexidine, 4-6 times higher MIG-values we re obtained at 3 and 6 months both when compared to baseline and in co mparison with the other two rinsing groups (p<0.01 or p<0.05). Neither delmopinol nor chlorhexidine showed any residual effect on the studie d 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 c onditions in the oral cavity.