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.