Jeffcoat M K, Bray K S, Ciancio S G, Dentino A R, Fine D H, Gordon J M, Gunsolley J C, Killoy W J, Lowenguth R A, Magnusson N I, Offenbacher S, Palcanis K G, Proskin H M, Finkelman R D, Flashner M
Department of Periodontics, University of Alabama, Birmingham 35294-0007, USA.
J Periodontol. 1998 Sep;69(9):989-97. doi: 10.1902/jop.1998.69.9.989.
The present studies evaluated the efficacy of a controlled-release biodegradable chlorhexidine (CHX) (2.5 mg) chip when used as an adjunct to scaling and root planing on reducing probing depth (PD) and improving clinical attachment level (CAL) in adult periodontitis. Two double-blind, randomized, placebo-controlled multi-center clinical trials (5 centers each) were conducted; pooled data are reported from all 10 centers (447 patients). At baseline, following 1 hour of scaling and root planing (SRP) in patients free of supragingival calculus, the chip was placed in target sites with PD 5 to 8 mm which bled on probing. Chip placement was repeated at 3 and/or 6 months if PD remained > or = 5 mm. Study sites in active chip subjects received either CHX chip plus SRP or SRP alone (to maintain study blind). Sites in placebo chip subjects received either placebo chip plus SRP or SRP alone. Examinations were performed at baseline; 7 days; 6 weeks; and 3, 6, and 9 months. At 9 months significant reductions from baseline favoring the chlorhexidine chip compared with both control treatments were observed with respect to PD (chlorhexidine chip plus SRP, 0.95 +/- 0.05 mm; SRP alone, 0.65 +/- 0.05 mm, P < 0.001; placebo chip plus SRP, 0.69 +/- 0.05 mm, P < 0.001) and CAL (chlorhexidine chip plus SRP, 0.75 +/- 0.06 mm; SRP alone, 0.58 +/- 0.06 mm, P < 0.05; placebo chip plus SRP, 0.55 +/- 0.06 mm, P < 0.05). The proportion of patients who evidenced a PD reduction from baseline of 2 mm or more at 9 months was significantly greater in the chlorhexidine chip group (19%) compared with SRP controls (8%) (P < 0.05). Adverse effects were minor and transient toothache, including pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity was the only adverse effect that was higher in the chlorhexidine group as compared to placebo (P = 0.042). These data demonstrate that the adjunctive use of the chlorhexidine chip results in a significant reduction of PD when compared with both SRP alone or the adjunctive use of a placebo chip. These multi-center randomized control trials suggest that the chlorhexidine chip is a safe and effective adjunctive chemotherapy for the treatment of adult periodontitis.
本研究评估了一种控释型可生物降解洗必泰（CHX）（2.5毫克）芯片作为龈下刮治和根面平整辅助手段，在降低成人牙周炎患者探诊深度（PD）和改善临床附着水平（CAL）方面的疗效。进行了两项双盲、随机、安慰剂对照的多中心临床试验（各有5个中心）；报告了来自所有10个中心（447名患者）的汇总数据。在基线时，对无龈上牙石的患者进行1小时的龈下刮治和根面平整（SRP）后，将芯片放置在探诊出血、PD为5至8毫米的目标部位。如果PD仍≥5毫米，则在3个月和/或6个月时重复放置芯片。使用活性芯片的研究部位的患者接受CHX芯片加SRP或仅接受SRP（以维持研究的盲法）。使用安慰剂芯片的研究部位的患者接受安慰剂芯片加SRP或仅接受SRP。在基线、7天、6周以及3、6和9个月时进行检查。在9个月时，与两种对照治疗相比，观察到使用洗必泰芯片组的PD较基线有显著降低（洗必泰芯片加SRP，0.95±0.05毫米；仅SRP，0.65±0.05毫米，P<0.001；安慰剂芯片加SRP，0.69±0.05毫米，P<0.001），CAL也有显著降低（洗必泰芯片加SRP，0.75±0.06毫米；仅SRP，0.58±0.06毫米，P<0.05；安慰剂芯片加SRP，0.55±0.06毫米，P<0.05）。在9个月时，与SRP对照组（8%）相比，洗必泰芯片组中PD较基线降低2毫米或更多的患者比例显著更高（19%）（P<0.05）。不良反应轻微且为短暂性牙痛，包括疼痛、压痛、酸痛、跳痛、疼痛、不适或敏感，是与安慰剂相比在洗必泰组中发生率更高的唯一不良反应（P=0.042）。这些数据表明，与单独使用SRP或使用安慰剂芯片辅助治疗相比，洗必泰芯片辅助使用可显著降低PD。这些多中心随机对照试验表明，洗必泰芯片是治疗成人牙周炎的一种安全有效的辅助化疗药物。
