López N J, Gamonal J A, Martinez B
Department of Conservative Dentistry, Faculty of Dentistry, University of Chile, Santiago.
J Periodontol. 2000 Jan;71(1):79-89. doi: 10.1902/jop.2000.71.1.79.
The prevailing concept is that little or no clear benefit is derived from antibiotic therapy in chronic periodontitis. Studies to determine the effect of metronidazole plus amoxicillin (M+A) on adult periodontitis are questionable because standard design for clinical trials was usually not used. In addition, there is no information about the effect of M+A as the sole therapy for periodontitis.
A randomized, triple-blind, controlled clinical trial was used to determine the effect of systemic administration of M+A, as the sole therapy, in progressive adult periodontitis. Forty-six subjects with moderate to advanced adult periodontitis who showed > or =2 mm attachment loss in at least 2 sites in the previous 2 months were entered in the study. Subjects were randomly distributed to a group who received 21 tablets of metronidazole 250 mg plus amoxicillin 500 mg, or to a group receiving a placebo (1 tablet every 8 hours for 1 week). Patients were examined every 2 months for 12 months. The M+A or placebo regimen was repeated at 4 and 8 months. No effort was made to change the oral habits of patients and they received no additional therapy. Differences between groups were assessed using the Mann-Whitney U test. The differences at every 2-month interval within each group were assessed using the ANOVA test.
Seven subjects abandoned the study; at 12 months the M+A group had 20 subjects and the placebo group 19. There were no significant differences in the clinical parameters at baseline between the 2 groups. After 2 months and thereafter, the M+A group showed significant clinical improvement while the placebo group showed a progressive deterioration of periodontal status. At 12 months compared to baseline, subjects of the M+A group showed: 1) a significant overall mean attachment gain of 0.43 mm (P = 0.005); 2) a significant decrease of active sites (P< or =0.03); 3) a significant increase of sites gaining attachment level (P< or =0.01); 4) a significant reduction of pocket depth (P< or =0.00006); and 5) a significant decrease in percentage of bleeding on probing sites (BOP) (P< or =0.0005). Significant differences between both groups at all 2-month evaluations were found in overall mean attachment level (P < or =0.000004), in percent of active sites (P< or =0.03), and in percent of BOP sites (P< or =0.02). Sites exhibiting > or =2 mm of attachment loss in 2 successive or alternate evaluations, and periodontal abscess were noticed only in the placebo group.
A 1-week course of systemic M+A every 4 months, as the only therapy, arrests the progression of adult periodontitis and significantly improves the clinical parameters of the disease.
目前普遍的观念是，抗生素治疗对慢性牙周炎几乎没有明显益处。由于通常未采用临床试验的标准设计，因此关于甲硝唑加阿莫西林（M+A）对成人牙周炎疗效的研究存在疑问。此外，尚无关于M+A作为牙周炎单一疗法疗效的相关信息。
采用随机、三盲、对照临床试验来确定全身应用M+A作为单一疗法对进展期成人牙周炎的疗效。46名患有中度至重度成人牙周炎且在过去2个月中至少有2个部位附着丧失≥2mm的受试者进入该研究。受试者被随机分为两组，一组接受21片250mg甲硝唑加500mg阿莫西林，另一组接受安慰剂（每8小时1片，共1周）。每2个月对患者进行一次检查，为期12个月。在4个月和8个月时重复M+A或安慰剂治疗方案。未对患者的口腔习惯进行干预，且他们未接受其他治疗。使用曼-惠特尼U检验评估组间差异。使用方差分析评估每组内每2个月间隔的差异。
7名受试者退出研究；12个月时，M+A组有20名受试者，安慰剂组有19名。两组基线时的临床参数无显著差异。2个月及之后，M+A组临床有显著改善，而安慰剂组牙周状况逐渐恶化。与基线相比，M+A组受试者在12个月时表现为：1）附着水平总体平均显著增加0.43mm（P = 0.005）；2）活动部位显著减少（P≤0.03）；3）附着水平增加的部位显著增多（P≤0.01）；4）牙周袋深度显著降低（P≤0.00006）；5）探诊部位出血百分比显著降低（P≤0.0005）。在所有2个月评估中，两组在总体平均附着水平（P≤0.000004）、活动部位百分比（P≤0.03）和探诊出血部位百分比（P≤0.02）方面均存在显著差异。仅在安慰剂组中发现连续或交替两次评估时附着丧失≥2mm的部位以及牙周脓肿。
每4个月进行一次为期1周的全身应用M+A治疗，作为唯一的治疗方法，可阻止成人牙周炎的进展，并显著改善该疾病的临床参数。
