Unit of Periodontology, Santa Apollonia Dental Center, Lazzate, MB, Italy.
J Periodontal Res. 2020 Jan;55(1):61-67. doi: 10.1111/jre.12686. Epub 2019 Aug 12.
The aim of the current clinical trial was to evaluate if the oral supplementation of melatonin after nonsurgical periodontal therapy (NSPT) determined a better periodontal healing than NSPT alone, in patients affected by untreated severe periodontitis.
Melatonin's anti-inflammatory, antioxidant and immunomodulatory capacities, together with its pharmacokinetic and pharmacodynamic profiles are key characteristics that justify the therapeutic use for the treatment of periodontitis.
This is a randomized, triple-blind, placebo-controlled study. Twenty patients were blindly randomized either to melatonin or placebo group. The melatonin group received NSPT and melatonin capsules 1 mg per day for 1 month, while the placebo, NSPT, and placebo capsules for 1 month. The patients were evaluated at baseline and 6 months after. Mean change from baseline probing depth (PD) was the primary outcome; site of probing was used as unit of analysis; FMBS (%) and FMPS (%) were also calculated. Mann-Whitney test was used to evaluate statistical significance (α = 0.05).
Melatonin was well tolerated by all patients. Both treatments were effective in reducing PD, but no statistical difference was found when comparing posttreatment PD (probing all sites), P = .62. When considering the primary outcome, melatonin administration resulted in greater mean PD change at 6 months if compared to control group: for 4-5 mm sites 1.86 (0.81) vs 1.04 (0.69), P = .00001 and for sites >5 mm 3.33 (1.43) vs 2.11 (0.96), P = .00012. No difference was found for FMBS and FMPS.
Current study, within its limitations, concluded that oral administration of melatonin (1 mg per day for 30 days) after one-stage full mouth NSPT determined a greater change from baseline PD if compared to NSPT alone, in untreated stage III periodontitis. This could provide a non-pharmacological support to improve periodontal healing of periodontal sites after NSPT.
本临床试验旨在评估非手术牙周治疗（NSPT）后口服褪黑素是否比单纯 NSPT 更能促进牙周愈合，对象为未经治疗的重度牙周炎患者。
褪黑素具有抗炎、抗氧化和免疫调节作用，其药代动力学和药效学特征是 justifies 其治疗牙周炎的治疗用途的关键特征。
这是一项随机、三盲、安慰剂对照研究。20 名患者被随机分为褪黑素组或安慰剂组。褪黑素组接受 NSPT 和 1 毫克/天的褪黑素胶囊治疗 1 个月，而安慰剂组接受 NSPT 和安慰剂胶囊治疗 1 个月。患者在基线和 6 个月后进行评估。从基线探诊深度（PD）的平均变化是主要结果；探诊部位为单位进行分析；还计算了 FMBS（%）和 FMPS（%）。Mann-Whitney 检验用于评估统计学意义（α=0.05）。
所有患者均能耐受褪黑素。两种治疗方法均能有效降低 PD，但比较治疗后 PD（所有探诊部位）时，差异无统计学意义（P=0.62）。当考虑主要结果时，与对照组相比，褪黑素给药在 6 个月时导致 PD 更大的平均变化：对于 4-5 毫米的部位为 1.86（0.81）与 1.04（0.69），P=0.00001；对于大于 5 毫米的部位为 3.33（1.43）与 2.11（0.96），P=0.00012。FMBS 和 FMPS 无差异。
本研究在其局限性内得出结论，即在一阶段全口 NSPT 后口服 1 毫克/天的褪黑素（持续 30 天）与单纯 NSPT 相比，在未经治疗的 III 期牙周炎中，导致 PD 从基线的更大变化。这可能为 NSPT 后改善牙周部位的牙周愈合提供非药物支持。
