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

Abstract

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.

6‐month use of 0.2% delmopinol hydrochloride in comparison with 0.2% chlorhexidine digluconate and placebo

“….Although delmopinol reduces the quantity of dental plaque, it has been shown that chlorhexidine is even more effective (Collaert et al 1992a, Moran et al 1992, Collaert et al 1992b). However, in the referred studies, as in the present one, no statistically significant differences were found between rinsing with 2 mg/ml solutions of delmopinol and chlorhexidine on gingival bleeding (Collaert et al, 1992a, b, Hase et al 1995b. One possible explanation for this lack of difference might be the varying modes of action of delmopinol and chlorhexidine.…”

“…chlorhexidine and placebo. These findings might be explained by the short duration of the study, the small number of patients and the Hawthorne effect (Hase et al 1995b). The influence of the Hawthorne effect was further shown in a 6 month study in which two concentrations of a flavoured delmopinol solution and a placebo solution were compared as an addition to normal oral hygiene (Claydon et al 1996).…”

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

“…The present study was the first delmopinol study to include patients with preexisting gingivitis. Only experimental plaque and gingivitis studies have been performed, including healthy volunteers without gingivitis (Moran et al, 1992, Hase et al 1995, or healthy volunteers with experimentally-induced gingivitis (Collaert et al I992ab, Collaert et al 1993a), This study should thus be regarded as a pilot study, performed not with the objective of drawing any conclusions regarding the efficacy of the drug compared with placebo, but to generate questions for future investigation. Also, all /i-values given in the study should be interpreted with caution due to comparisons of multiple related symptoms.…”

“…1992). The most common treatment-related symptom reported for delmopinol was a transient anaesthetic sensation of the tip ofthe tongue (Collaert et al 1992a, b, 1993a, c, Moran et al 1992, Hase et al 1995. The overall severity of this symptom was mild.…”

“…When 10 ml of an aqueous solution of delmopinol hydrochloride (henceforth called delmopinol) 0.5 mg'ml, 1 mg/ml and 2 mg; ml was used as an unsupervised mouthrinse for 60 s 2x daily for 2 weeks, delmopinol showed a statistically significant dose-response effect regarding both the inhibition of plaque formation and decreasing the experimentally induced gingivitis {Collaert et al 1992a). In two supervised studies, one 4-day (Moran et al 1992) and one 14-day (Hase et al 1995), rinsing 2x daily for 60 s with 10 ml of an aqueous solution of delmopinol 2 mg/ml resulted in significantly less plaque formation than placebo.…”