Evaluation of Long-Term Effects of Diode Laser Application on Periodontal Healing, Serum C-Reactive Protein and HbA1c Levels in Periodontal Treatment of Uncontrolled Type-2 Diabetic Subjects With Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Laboratory findings
研究概览
简要总结
This study aimed to investigate the effects of diode laser (DL) in addition to non-surgical periodontal treatment on periodontal parameters, systemic inflammatory response, and serum hemoglobin A1c (HbA1c) level in patients with uncontrolled type 2 diabetes mellitus (T2DM) and chronic periodontitis.
详细描述
This study was designed as a randomized, controlled, full-mouth, 6-month clinical trial. 37 patients (20 women and 17 men) with uncontrolled T2DM and chronic periodontitis who were selected from among those admitting to Dentistry Faculty of Inonu University and Turgut Ozal Medical Center completed this study. The patients were divided into two groups. The individuals in the control group underwent placebo laser treatment in addition to scaling and root planing (SRP). The individuals in the study group underwent DL (1 W power) in addition to SRP. Clinical index measurements were performed before treatment (T0), 3 months after treatment (T1), and 6 months after treatment (T2). Plaque index (PI), gingival index (GI), bleeding on probing (BOP), clinical attachment level (CAL), and probing depth (PD) were measured to determine periodontal status. HbA1c and C-reactive protein (CRP) levels were also analyzed using blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The results of the study were evaluated in a blinded manner
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a diagnosis of type-2 DM according to the ADA criteria for at least two years before the study, HbA1c⩾7%,28
- •Having no change in antidiabetic drugs in the last 3 months,
- •Having no major diabetes complications (because chronic complications of diabetes complicate metabolic control),
- •Presence of generalized CP,29
- •Presence of an area with a pocket depth of 4-7 mm in at least four teeth in the upper jaw,
- •Presence of at least 20 teeth in the mouth,
- •Having no any systemic illness except for DM,
- •Having no smoke,
- •Receiving no periodontal treatment in the last 12 months,
- •Receiving no antibiotics or anti-inflammatory drugs for a long period in the last 6 months,
- •Not being pregnant or not to breastfeed,
- •Having no third molars.
排除标准
- 未提供
研究组 & 干预措施
Study group
SRP plus diode laser (810 nm wavelength, 1 W power)
干预措施: Laser group (Device)
Control group
SRP plus placebo
干预措施: Control group (Device)
结局指标
主要结局
Laboratory findings
时间窗: Six months
Serum HbA1c levels were measured using the high-performance liquid chromatography method.
次要结局
- Clinical findings(Six months)
研究者
Abubekir Eltas
Director
Çanakkale Onsekiz Mart University