Doxycycline encapsulated in β-cyclodextrin for periodontitis: a clinical trial

Abstract This clinical trial compared the efficacy of doxycycline (DOX) in β-cyclodextrin (DOX)/βCD) with DOX- alone in gel on thirty-three subjects with periodontitis. Patients were randomized to group 1 GI; 10% DOX + scaling and root planning (SRP); group 2 (GII (10% DOX /β-CD + SRP), and group 3 (GIII; SRP). Gels were applied in GI and GII at baseline (T0) and 30 days later (T1). Periodontal Probing Depth (PPD), Clinical Attachment Level (CAL), Bleeding on Probing (BOP) and Visible Plaque Index (VPI) were evaluated at (T0), 30 days (T1) and 60 days after T0 (T2). Bone density was analyzed after 18 months (T3). GII showed the most significant reduction of PPD (2.62 mm; p <0.003), and greatest gain in CAL (2.54 mm p <0.003) at T2. BOP and the VPI had a strong reduction in all groups at T2 (p <0.05), both decreased by ≥5 times and 2 times, respectively, in all groups at T1. Bone density increased in all groups in radiographs (T3). The use of DOX encapsulated in β-CD gel with SRP resulted in significant improvements in clinical periodontal parameters; such molecular inclusion of doxycycline into β-CD in gel for local application is relatively simple and useful in dentistry.

摘要 本临床试验对比了β-环糊精（β-cyclodextrin）包载多西环素（doxycycline, DOX）凝胶与单纯多西环素凝胶对33名牙周炎受试者的治疗效果。受试者被随机分为3组：第1组（GI组）：10%多西环素联合龈下刮治与根面平整（scaling and root planning, SRP）；第2组（GII组）：10%多西环素/β-环糊精联合SRP；第3组（GIII组）：仅接受SRP。GI组与GII组分别在基线（T0）及30天后（T1）局部应用凝胶。分别于T0、T1（基线后30天）与T2（基线后60天）评估牙周探诊深度（periodontal probing depth, PPD）、临床附着水平（clinical attachment level, CAL）、探诊出血（bleeding on probing, BOP）及可见菌斑指数（visible plaque index, VPI）；并在18个月后（T3）检测骨密度。结果显示，在T2时，GII组的PPD降幅最为显著（2.62 mm；p<0.003），CAL提升幅度最大（2.54 mm，p<0.003）。T2时所有组别均出现BOP与VPI的显著降低（p<0.05）；其中T1时所有组的BOP与VPI分别下降≥5倍与2倍。影像学检查显示，T3时所有组的骨密度均有所升高。综上，将多西环素包埋于β-环糊精凝胶中联合SRP治疗，可显著改善牙周临床指标；这种将多西环素分子载入β-环糊精凝胶用于局部给药的方法在牙科领域操作相对简便且具有良好应用价值。