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临床试验/NCT02652026
NCT02652026已完成不适用

Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients

University of Barcelona0 个研究点目标入组 90 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
Change from baseline in Glycosylated Hemoglobin (HbA1c)

研究概览

简要总结

The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.

详细描述

Background: Periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years.

Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM).

Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI + supragingival removal of plaque and calculus with ultrasonic device). CG patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. There will be a single examiner, blind and calibrated to improve reproducibility. The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c, improving metabolic control in patients with DM

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in Glycosylated Hemoglobin (HbA1c)

时间窗: Baseline and 6 months after intervention

Serum levels glycosylated hemoglobin

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

elisabet mauri i obradors

Dentistry

University of Barcelona

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