The effects of non-surgical periodontal treatment on glycemic control, oxidative stress balance and quality of life in patients with type 2 diabetes: A randomized clinical trial

Aim
The purpose of this study was to investigate the effects of non-surgical periodontal treatment on hemoglobinA1c (HbA1c) levels, oxidative stress balance and quality of life (QOL) in patients with type 2 diabetes mellitus (T2DM) compared to no periodontal treatment (simple oral hygiene instructions only).
Methods
The design was a 6-month, single-masked, single center, randomized clinical trial. Patients had both T2DM and chronic periodontitis. Forty participants were enrolled between April 2014 and March 2016 at the Nephrology, Diabetology and Endocrinology Department of Okayama University Hospital. The periodontal treatment group (n = 20) received non-surgical periodontal therapy, including scaling and root planing plus oral hygiene instructions, and consecutive supportive periodontal therapy at 3 and 6 months. The control group (n = 17) received only oral hygiene instructions without treatment during the experimental period. The primary study outcome was the change in HbA1c levels from baseline to 3 months. Secondary outcomes included changes in oxidative stress balance (Oxidative-INDEX), the Diabetes Therapy-Related QOL and clinical periodontal parameters from baseline to 3 months and baseline to 6 months.
Results
Changes in HbA1c in the periodontal treatment group were not significantly different with those in the control group at 3 and 6 months. Systemic oxidative stress balance and QOL significantly improved in the periodontal treatment group compared to the control group at 3 months. In the subgroup analysis (moderately poor control of diabetes), the decrease in HbA1c levels in the periodontal treatment group was greater than that in the control group at 3 months but not significant.
Conclusions
In T2DM patients, non-surgical periodontal treatment improved systemic oxidative stress balance and QOL, but did not decrease HbA1c levels at 3 months follow-up.
Trial registration
Current Controlled Trials UMIN-ICDR UMIN 000013278 (Registered April 1, 2014).

研究目的
本研究旨在探讨与仅接受单纯口腔卫生指导的无牙周治疗组相比，非手术牙周治疗对2型糖尿病（type 2 diabetes mellitus, T2DM）患者的糖化血红蛋白A1c（hemoglobinA1c, HbA1c）水平、氧化应激平衡及生活质量（quality of life, QOL）的影响。

研究方法
本研究设计为一项为期6个月的单盲、单中心随机临床试验。研究对象同时罹患2型糖尿病与慢性牙周炎。2014年4月至2016年3月期间，于冈山大学医院肾脏内科、糖尿病与内分泌科招募了40名受试者。牙周治疗组（n=20）接受非手术牙周治疗，包括龈上洁治与龈下刮根平整术联合口腔卫生指导，并在术后3个月和6个月接受连续性支持性牙周治疗；对照组（n=17）仅接受口腔卫生指导，实验期间不接受其他牙周治疗。本研究的主要结局指标为从基线至3个月时HbA1c水平的变化；次要结局指标包括从基线至3个月、基线至6个月时氧化应激指数（Oxidative-INDEX）、糖尿病治疗相关生活质量以及临床牙周参数的变化。

研究结果
在3个月和6个月随访时，牙周治疗组与对照组的HbA1c变化无显著差异。与对照组相比，牙周治疗组在3个月时的全身氧化应激平衡与生活质量均得到显著改善。亚组分析（糖尿病控制中等不佳亚组）显示，牙周治疗组在3个月时的HbA1c水平降幅大于对照组，但该差异未达到统计学显著性。

结论
对于2型糖尿病患者，非手术牙周治疗可改善其全身氧化应激平衡与生活质量，但在3个月随访时未降低HbA1c水平。

试验注册
当前受控试验（Current Controlled Trials）UMIN-ICDR UMIN 000013278（2014年4月1日注册）。