Department of Periodontics & Implantology, VSPM Dental College and Research Center, Nagpur, India.
J Periodontol. 2022 Dec;93(12):1878-1888. doi: 10.1002/JPER.21-0515. Epub 2022 Apr 8.
The present study aims to evaluate and compare the efficacy of locally delivered 1% melatonin gel as an adjunct to non-surgical periodontal therapy (NSPT) in treatment of intrabony defect in Stage III periodontitis, clinically, and radiographically using cone-beam computed tomography (CBCT).
This split-mouth clinical trial randomly allotted 44 bilateral intrabony defect (in 22 patients) into two groups where Group I was treated with NSPT with locally delivered placebo gel while Group II was treated with NSPT with 1% melatonin gel. The intrabony defect fill measured from cemento-enamel junction (CEJ)-base of the defect (BD), and the difference in the measurement values of CEJ-BD from baseline to 6 months denoting the bone fill and bone volume evaluated at 6 months using CBCT were the primary outcome measures. Secondary outcome measures were change in probing depth (PD), clinical attachment level (CAL), plaque index, and modified sulcus bleeding index recorded at baseline, 3 months, and 6 months.
Both the study groups showed improvements in assessed parameters, however, a significant gain in intrabony defect fill was observed in Group II (1.46 ± 0.58) as compared with Group I (0.50 ± 0.38) and change in bone volume for Group I was 21.4645 ± 8.8980 mm and for Group II was 51.8418 ± 30.2329 mm with P < 0.0001.The mean reduction in PD and gain in CAL was 3.90 ± 0.78 and 2.94 ± 0.80 in Group II and in Group I it was 3.23 ± 0.90 and 1.96 ± 0.80 (P < 0.0001).
The use of 1% melatonin gel as an adjunct to NSPT is more beneficial in achieving better clinical and radiographic outcome at 6 months which indicates that adjunct use of melatonin gel to NSPT as a local drug delivery is preferred when compared with NSPT and placebo gel alone.
本研究旨在通过锥形束计算机断层扫描（CBCT）评估和比较局部应用 1%褪黑素凝胶作为非手术牙周治疗（NSPT）辅助手段治疗牙周炎 III 期牙槽骨缺损的疗效，临床和放射学。
这项分口临床试验将 44 个双侧牙槽骨缺损（22 名患者）随机分为两组，其中 I 组接受 NSPT 联合局部应用安慰剂凝胶治疗，而 II 组接受 NSPT 联合 1%褪黑素凝胶治疗。从釉牙骨质界（CEJ）-缺损底部（BD）测量牙槽骨缺损填充量，以及从基线到 6 个月 CEJ-BD 测量值的差异表示骨填充和骨量，使用 CBCT 在 6 个月时评估，这些是主要的观察指标。次要观察指标是基线、3 个月和 6 个月时记录的探诊深度（PD）、临床附着水平（CAL）、菌斑指数和改良龈沟出血指数的变化。
两组研究均显示评估参数有所改善，但 II 组（1.46 ± 0.58）的牙槽骨缺损填充量显著增加，而 I 组（0.50 ± 0.38），I 组的骨量变化为 21.4645 ± 8.8980mm，II 组为 51.8418 ± 30.2329mm，P < 0.0001。PD 平均降低和 CAL 平均增加分别为 II 组 3.90 ± 0.78 和 2.94 ± 0.80，I 组分别为 3.23 ± 0.90 和 1.96 ± 0.80（P < 0.0001）。
1%褪黑素凝胶作为 NSPT 的辅助手段在 6 个月时更有利于获得更好的临床和放射学结果，这表明与 NSPT 和安慰剂凝胶单独使用相比，将褪黑素凝胶作为局部药物输送联合 NSPT 使用更具优势。
