6-month use of 0.2% delmopinol hydrochloride in comparison with 0.2% chlorhexidine digluconate and placebo (II). Effect on plaque and salivary microflora.

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.

6-month use of 0.2% delmopinol hydrochloride in comparison with 0.2% chlorhexidine digluconate and placebo. (I). Effect on plaque formation and gingivitis.

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.

Plaque formation and gingivitis after supervised mouthrinsing with 0.2% delmopinol hydrochloride, 0.2% chlorhexidine digluconate and placebo for 6 months.

OBJECTIVES AND METHODS: A double-blind, randomized, 6-month clinical trial with parallel group design in 162 patients with gingivitis divided into three rinsing groups was conducted in order to study the efficacy and safety of a flavoured solution of delmopinol hydrochloride 2 mg ml-1 (0.2% w/v, Decapinol Mouthwash) used for supervised mouthrinsing in one rinsing group, in comparison with chlorhexidine digluconate 2 mg ml-1 (0.2% w/v, Hibitane Dental) in a second rinsing group, and placebo in the third group. The criteria of the Plaque Index (PI) were used to assess plaque formation. Bleeding on probing (BOP) to the bottom of the pocket with a standard pressure was used as the primary gingivitis assessment. The occurrence of supragingival dental calculus and extrinsic tooth staining were also assessed. In addition, patients were asked to report adverse events at each visit. RESULTS: Delmopinol and chlorhexidine exhibited lower scores of the mean PI and the BOP percentage than placebo, both at the 3-month and 6-month examinations. Furthermore, both active solutions showed a higher extent of staining of the teeth than placebo during these two observation periods. Rinsing with chlorhexidine resulted in more dental calculus than placebo after 6 months. Chlorhexidine showed lower scores for plaque formation and gingivitis development but higher scores of supragingival dental calculus (after 6 months) and tooth staining than did delmopinol. Both active solutions were reported by the patients--approximately to the same extent but more frequently than placebo--to induce taste alterations and a transient anaesthetic sensation of the oral mucosa. However, subjective staining of the teeth and tongue was reported by 16% of the delmopinol patients, but by 86% of the patients rinsing with chlorhexidine for 6 months. Furthermore, 24% of the patients in the chlorhexidine group, 9% in the delmopinol group and 4% in the placebo group wished to withdraw from treatment. CONCLUSIONS: The results from this clinical trial indicate that supervised rinsing with 0.2% delmopinol hydrochloride or with 0.2% chlorhexidine digluconate twice daily for 60 s as a supplement to normal mechanical oral hygiene procedures resulted in less plaque formation and gingivitis than rinsing with placebo. Although chlorhexidine was more effective than delmopinol regarding plaque formation and gingivitis, it was considered by the patients as less tolerable.

Plaque formation and gingivitis after mouthrinsing with 0.2% delmopinol hydrochloride, 0.2% chlorhexidine digluconate and placebo for 4 weeks, following an initial professional tooth cleaning.

A double-blind, randomised, 4-week clinical trial with parallel group design in 57 patients with gingivitis was conducted for studying the antibacterial efficacy and safety of a delmopinol HCl aqueous solution 2 mg/ml (0.2% w/v), which was used for unsupervised mouth-rinsing and compared with placebo and chlorhexidine digluconate 2 mg/ml (0.2% w/v, Hibitane Dental, ICI Pharmaceuticals, UK). The plaque index and plaque wet weight were used to measure plaque formation, and gingival fluid flow and bleeding on probing to measure gingivitis. According to the reduction from baseline, chlorhexidine showed a significantly better effect on plaque formation than the placebo after 4 weeks treatment for both plaque measurements. Delmopinol exhibited significantly lower plaque index scores than placebo. The difference between chlorhexidine and delmopinol was not statistically significant for any of the plaque measurements. For gingivitis, no statistically significant differences were obtained between the effects of delmopinol, chlorhexidine and placebo. A transient anaesthetic sensation in the oral mucosa was experienced more clearly by the patients in the delmopinol group than by those using chlorhexidine or placebo rinses. Rinsing with chlorhexidine resulted in more staining of the teeth and tongue than did delmopinol and placebo. The placebo solution tasted better than the 2 active solutions. The results showed that rinsing with either delmopinol HCl aqueous solution 2 mg/ml or chlorhexidine digluconate 2 mg/ml 2x daily for 60 as a supplement to normal oral hygiene, following an initial professional tooth cleaning, leads to a lower plaque formation than rinsing with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

Development of plaque and gingivitis after mouthrinsing with 0.2% delmopinol hydrochloride.

A double-blind, randomized, 2-wk experimental gingivitis clinical trial with cross-over design in 14 dental students was conducted in order to study the efficacy and safety of delmopinol hydrochloride solution (2 mg/ml), used with no other oral hygiene procedures, in comparison with placebo. Plaque formation was measured by the Quigley & Hein Plaque Index and gingivitis was assessed by bleeding on probing according to Mühlemann & Son. Rinsing with delmopinol resulted in lower plaque scores compared to placebo. The development of gingivitis was weak during the 2-wk test periods, and thus no conclusive results were obtained. As in previous studies, the most frequent adverse event when rinsing with delmopinol was a transient anaesthetic sensation in the oral mucosa. The results showed that rinsing with delmopinol hydrochloride solution (2 mg/ml) for 60 s twice daily with no other oral hygiene procedures led to less plaque formation than rinsing with placebo. This study also showed good tolerance and acceptability of mouthrinsing with delmopinol.

Oral retention of glucose at pharmacologically reduced salivary flow in man.

The aim was to study the influence of mouthrinses with glucose, at concentrations ranging from 1 to 50%, on oral retention at two different locations in the oral cavity. Salivary secretion was reduced in 10 subjects by injection of methylscopolamine nitrate submucosally. The volunteers were randomly assigned to rinse with 10 ml of either 1%, 10%, or 50% glucose solution for 30 s, after which measurements of glucose concentration and parotid salivary secretion rate were performed during a 10-min period. The results showed higher salivary glucose levels vestibularly than sublingually. The difference in glucose retention between the two locations increased when the salivary flow rate recovered. The relationship between secretion rate and area under the curve for glucose measured sublingually, but not in the vestibule, was bilinear.

Short-term effect of topical application of delmopinol on salivary microbiology, plaque, and gingivitis.

The aim of this study was to test a possible dose-response effect of topical application of delmopinol HCl on the salivary microbiology, the healing of a pre-established experimental gingivitis, plaque development, and supragingival plaque composition. Forty-eight healthy subjects were enrolled in an oral hygiene program for 2 wk to upgrade their oral health. After professional tooth cleaning, they abstained from all oral hygiene, but applied 2 ml of a placebo with a soft paintbrush onto their teeth twice daily for 2 wk. At the end of this period, the subjects received tooth cleaning and were then assigned to three treatment groups of 16 individuals each. They applied 2 ml of 0.1%, 0.5%, and 1% delmopinol HCl, respectively, twice daily for the next 2 wk and refrained from all other oral hygiene procedures. At the end of the placebo and delmopinol HCl treatment periods, (1) saliva samples were obtained and cultivated on a series of media, (2) the degree of gingivitis was measured with gingival crevicular fluid (GCF) and gingivitis index (GI), (3) the stainable buccal plaque extension was analyzed planimetrically, and (4) the bacterial morphotypes of plaque adjacent to the gingival margin were analyzed. No changes in the salivary microbiologic counts were detected. The amounts of GCF and GI were reduced in all delmopinol groups, as compared with placebo. Mean plaque extension was reduced by 16% for the 0.1%, 56% for the 0.5%, and 58% for the 1% delmopinol group. Cocci appeared to predominate in bacterial dental plaque when 0.5% and 1% delmopinol were used.(ABSTRACT TRUNCATED AT 250 WORDS)

Scanning electron microscopic observations of early plaque formation in vivo on enamel specimens treated with delmopinol.

The aim of this double blind, cross-over, scanning electron microscopic (SEM) study was to compare the effect of topical application of 0.5% delmopinol HCl (aqueous solution) with placebo on early supragingival plaque formation on enamel specimens attached to a maxillary premolar. 3 subjects underwent 2x (placebo and delmopinol treatment, respectively) 7 treatment periods (1/2, 1, 2, 8, 24 hours; 3, 7 days) of undisturbed dental plaque accumulation, during which 2 ml of placebo and delmopinol HCl 0.5%, respectively, were applied topically to all teeth 2x daily. At the end of each period, the specimen was retrieved and processed for SEM. For the specimens obtained after 24 h or less, the number of visible micro-organisms was estimated. For the 3- and 7-day specimens, the area covered by plaque was calculated planimetrically. Large inter-individual differences were observed in the number of bacteria attaching during the first 24 h, with apparently no major differences between delmopinol and placebo. 1 subject showed a bacterial colonization predominated by curved rods throughout the first 8 h. Compared to placebo, the area of the specimens covered by plaque was reduced after 3 and 7 days of delmopinol use, with coccoid cells as the predominant morphotype. Plaque maturity, characterized by the appearance of corncob formations and high numbers of different morphotypes, was not observed on the delmopinol specimens, in contrast to the placebo specimens. The study shows that topical application of 0.5% delmopinol HCl delays and interferes with dental plaque maturation.

Microbiology of early supragingival plaque development after delmopinol treatment.

The aim of this double blind, cross-over, microbiological study was to compare the effect of topical application of the plaque control agent 0.5% delmopinol HCl with placebo on early supragingival plaque formation. Six subjects underwent 7 periods (0.5, 1, 2, 8 and 24 h and 3 and 7 days) of placebo and delmopinol application, respectively. At the start of each study period the teeth were professionally cleaned and 2 ml of placebo and delmopinol 0.5%, respectively, were applied on all teeth (twice daily for periods lasting 24 h or more). At the end of each period, supragingival plaque samples of one upper and one lower buccal tooth surface were collected separately and cultured on anaerobically incubated Brucella blood agar, on aerobically incubated blood agar and on selective media for the enumeration of Streptococcus spp., Haemophilus spp., Actinomyces spp., Veillonella spp., Neisseria spp. and Fusobacterium spp. The total anaerobic cultivable microflora after delmopinol use was 10-100 times lower than after placebo use. Compared with placebo, the proportion of cultivable aerobes (61.3%), Streptococcus spp. (104.8%) and Haemophilus spp. (82.3%) increased and the proportion of Actinomyces spp. (86.1%), Veillonella spp. (60.5%), Neisseria spp. (96.9%) and Fusobacterium spp. (60.6%) decreased after 7 days. Short-term application of 0.5% delmopinol HCl on supragingival dental plaque regrowth resulted in a reduction of the number of cultivable microorganisms in the plaque and produced a shift in the cultivable plaque composition.

Influence of age and salivary secretion rate on oral sugar clearance.

The influence of age and salivary flow on oral sugar clearance was studied. Saliva was sampled with small circular paper discs, absorbing a certain amount of saliva. Glucose concentration was analysed enzymatically. Salivary glucose clearance was estimated in: (i) children of various ages and adults, (ii) hospitalised elderly patients, elderly people living at home and middle-aged adults, and (iii) elderly individuals with various types of prosthodontic reconstructions. Furthermore, an experimental model with pharmacologically reduced salivary flow was used to evaluate the relationship between salivary glucose clearance and salivary flow, also taking into consideration pH changes in dental plaque and the sugar intake concentration. In addition, an attempt to speed up prolonged oral sugar clearance in a group of hospitalised elderly patients was made with an individual programme. The main findings were that 3-year-olds exhibited higher salivary glucose concentration levels and greater variations in glucose clearance between different food products than older children and adults. Elderly people, especially hospitalised patients, cleared sugar from the oral cavity less effectively than young and middle-aged adults. Removable dentures, particularly complete dentures, contributed to higher salivary sugar concentration in elderly people. Higher glucose levels in saliva and more pronounced pH drops in dental plaque were obtained at low than at normal salivary flow. There was a bi-linear relationship between salivary glucose clearance sublingually and salivary secretion rate. Small changes in salivary flow below the border line values--which correspond to the intersection between the two phases--resulted in relatively large differences in clearance. It was possible to speed up prolonged oral sugar clearance in hospitalised elderly patients by using an individual training programme. To conclude, oral sugar clearance was comparatively slow in young children and in hospitalised elderly patients. A low salivary secretion rate was found to affect oral sugar clearance negatively.

Rinsing with delmopinol 0.2% and chlorhexidine 0.2%: short-term effect on salivary microbiology, plaque, and gingivitis.

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.(ABSTRACT TRUNCATED AT 250 WORDS)

An individual training programme for speeding up prolonged oral sugar clearance in hospitalized elderly patients. A pilot study.

The aim of this pilot study was to evaluate an individual programme for speeding up prolonged oral sugar clearance in hospitalised elderly patients. Six patients at a university hospital for geriatric medicine, aged 67-85 years, completed a 6-week study. Every second week one of the authors gave: 1) information on the importance of oral sugar clearance for oral health, 2) instruction in oral hygiene, and 3) professional tooth cleaning. Moreover, the staff responsible for each patient provided 1) massage and training of the lips, cheeks and tongue shortly before each main meal, 3 times daily, 2) supervision of chewing on a sugar-free chewing gum for at least 20 min, 4 times daily, and 3) support and encouragement of the patients throughout the day. Salivary glucose clearance was measured both sublingually and vestibularly in the lower jaw after chewing a glucose tablet and after a mouth rinse with 10% glucose solution. There was a clear tendency that the oral sugar clearance was reduced after the 6-week period and some of the reductions in the clearance variables were statistically significant. All patients, especially those suffering from cerebral haemorrhage, reported an improved ability to chew while proceeding with the programme, which was also confirmed by the staff. The main conclusion from this pilot study is therefore that it might be possible to speed up prolonged oral sugar clearance in elderly hospitalised patients using an individual training programme.

Oral sugar clearance in elderly people with prosthodontic reconstructions.

The aim was to study oral sugar clearance in elderly individuals, around 70 yr of age, with various types of prosthodontic reconstructions. Salivary glucose concentration was measured under the tongue after chewing a glucose tablet in four groups of individuals with: 1) complete dentures (CD) (n = 19), 2) removable partial dentures (RPD) (n = 22), 3) fixed partial dentures (FPD) (n = 24), and 4) no dentures (controls) (n = 23). Salivary glucose clearance was also studied after a mouthrinse with 10% glucose in 18 of the 19 individuals with CD and in 13 of the 22 with RPD both with and without the dentures. Saliva samples for glucose analysis were taken, in this part of the experiment, at two separate locations: under the tongue and in the labial vestibule near the mandibular right first molar. After the tablet intake, the group with CD showed the highest initial salivary glucose concentration, the longest oral sugar clearance time and the largest area under the curve, followed by the group with RPD. FPD did not seem to influence the oral sugar clearance. After the glucose rinse, higher values for the various clearance variables were obtained in the vestibule than under the tongue and, to some extent, when the experiments were carried out with than without the dentures. Thus, the results from this study indicate that removable dentures, especially CD, contribute to less effective oral sugar clearance in elderly people and that the oral clearance seems to be more dependent on the site than on the presence or absence of removable dentures in the oral cavity.

Oral sugar clearance in children compared with adults.

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-years-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 microliters 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.

Effect on approximal caries in teenagers of interrupting a school-based weekly NaF mouthrinse program for 3 years.

The aim of the present investigation was to follow the caries incidence in 126 13-yr-old children who experienced a 3-yr interruption of a supervised weekly mouthrinse program with 0.2% NaF solution (interrupted rinsing-, IR-group). 143 children, 13 yr old, who continuously participated in the NaF mouthrinse program, served as a comparison group (continuous rinsing-, CR-group). Dental caries and restorations were diagnosed on bitewing radiographs; thus only approximal tooth surfaces were considered. The caries incidence over the 3-yr period was 1.84 DFS in the IR- and 1.77 in the CR-group. The corresponding FS-values were 0.67 and 0.25, respectively. Two years later, i.e. when the children were 18-yr-old and the IR-group had had 2 yr back on the school-based mouthrinse program, they were examined again. The difference in caries incidence between 16 and 18 yr of age was still small, 1.32 DFS in the IR- and 1.22 in the CR-group. The corresponding FS-values were 0.63 and 0.49, respectively. Thus, this study showed that the 3-yr interruption of the NaF mouthrinse program resulted in a small, statistically non-significant increase in caries, mostly as regards the number of fillings, on approximal tooth surfaces.

Salivary glucose clearance, dry mouth and pH changes in dental plaque in man.

The aim was to study the effect of different salivary secretion rates on glucose clearance in saliva and on pH changes in dental plaque in man. Eighteen dental students, 21-33 yr old, participated. Dry mouth was induced by injecting methylscopolamine-nitrate submucosally in the labial sulcus. When dry mouth was established, two variables were measured at 1 h intervals, while the salivary flow was recovering: (1) secretion rate of resting and paraffin wax-stimulated whole saliva, and (2) glucose clearance in saliva after ingestion of a glucose tablet. pH changes in dental plaque were studied in 9 of the 18 subjects after a mouth rinse with 10% glucose at two separate occasions, once before and once after an injection of methylscopolamine-nitrate. Higher glucose concentration levels in saliva were found at low than at normal salivary secretion rate. After logarithmic transformation of the salivary glucose concentration values, a biphasic elimination pattern could be seen, with a steeper initial phase followed by a slower one. A critical value for the secretion rate with respect to the salivary glucose clearance time was found to be 0.14 ml/min for resting and 0.62 ml/min for stimulated whole saliva (mean values). The pH changes in dental plaque after the mouth rinse with glucose at extremely low secretion rate were significantly more pronounced than at normal flow rate. Thus, salivary secretion rate affects both the glucose clearance in saliva and the pH changes in dental plaque in man.