Lang N P, Hase J C, Grassi M, Hämmerle C H, Weigel C, Kelty E, Frutig F
Department of Periodontology and Fixed Prosthodontics, University of Berne, Switzerland.
Oral Dis. 1998 Jun;4(2):105-13. doi: 10.1111/j.1601-0825.1998.tb00266.x.
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.
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.
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.
对162例牙龈炎患者进行了一项为期6个月的双盲、随机、平行组设计的临床试验，将患者分为三个漱口组，以研究2mg/ml（0.2%w/v，地莫匹醇漱口水）加味溶液在一个漱口组中用于监督漱口的疗效和安全性，与第二漱口组中的2mg/ml葡萄糖酸洗必泰（0.2%w/v，洗必泰口腔液）以及第三组中的安慰剂进行比较。采用菌斑指数（PI）标准评估菌斑形成情况。用标准压力探诊牙周袋底部出血情况（BOP）作为牙龈炎的主要评估指标。还评估了龈上牙石和外源性牙齿染色的发生情况。此外，要求患者在每次就诊时报告不良事件。
在3个月和6个月检查时，地莫匹醇和洗必泰的平均PI和BOP百分比得分均低于安慰剂。此外，在这两个观察期内，两种活性溶液导致的牙齿染色程度均高于安慰剂。6个月后，用洗必泰漱口产生的牙石比安慰剂更多。与地莫匹醇相比，洗必泰在菌斑形成和牙龈炎发展方面得分较低，但龈上牙石（6个月后）和牙齿染色得分较高。患者报告两种活性溶液均会引起味觉改变和口腔黏膜短暂麻醉感，程度大致相同，但比安慰剂更频繁。然而，16%使用地莫匹醇的患者报告牙齿和舌头有主观染色，而6个月来用洗必泰漱口的患者中有86%报告有此情况。此外，洗必泰组24%的患者、地莫匹醇组9%的患者和安慰剂组4%的患者希望退出治疗。
该临床试验结果表明，作为正常机械口腔卫生程序的补充，每天两次用0.2%盐酸地莫匹醇或0.2%葡萄糖酸洗必泰监督漱口60秒，与用安慰剂漱口相比，可减少菌斑形成和牙龈炎。虽然在菌斑形成和牙龈炎方面洗必泰比地莫匹醇更有效，但患者认为其耐受性较差。
