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临床试验/NCT03764410
NCT03764410已完成不适用

Evaluation of Periodontal Clinical Parameters and Blood Tests in Diabetic Patients Submitted to Non-surgical Periodontal Treatment

Universidade Metropolitana de Santos1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
blood test fasting blood glucose

研究概览

简要总结

Unfavorable systemic conditions condition a low resistance of the host to the virulence of the aggressive agent, causing in a periodontal disease and may lead to difficulties in the therapeutic response. The longer the duration of diabetes, it is suggested that greater severity of periodontal disease and loss of insertion. The objective of the present study will be to evaluate the clinical, microbial and immunological characteristics in diabetic subjects with chronic periodontitis submitted to non-surgical periodontal treatment. Will be 120 individuals with chronic periodontitis, including 60 type 2 diabetic subjects and 60 healthy should receive and have access to the informed consent form. Medical and dental clinical examination should be performed and evaluation microbial and immunological properties of gingival fluid and saliva respectively. Non-surgical periodontal therapy with subgingival scaling should be performed in all individuals who will be evaluated at two times: at the beginning and after 90 days of the periodontal therapy with new performing clinical exams and collecting oral samples, oral hygiene instructions will be addressed in two sessions. The data will be subjected to appropriate statistical tests and shall provide a comparison between the times. There seems to be a relationship between type 2 diabetes and periodontal disease and studies that provide the implementation of therapy are essential for clarifying the relationship.

详细描述

There is a need for more intense metabolic control of the diabetic patient with periodontal disease, since the destruction of the periodontal tissues may be more aggressive, and a rapid control of the oral infection in these patients is essential to avoid the exacerbation of the metabolic imbalance. The initiation and progression of diabetes probably involve the interaction of a multiplicity of factors, these being hereditary and immunological factors that are governed by environmental factors. It can be observed that there is a lack of awareness of oral complications between diabetics and health care providers, and it is extremely important to understand how diabetes affects oral health and there is a need for regular follow-up of patients with diabetes mellitus by dentists and medical professional. The objective of the present study was to evaluate diabetic individuals with chronic periodontitis submitted to non-surgical periodontal treatment using clinical parameters and blood tests of fasting glycemia and glycated hemoglobin. The study was approved by the Research Committee of the Metropolitan University of Santos, nº 1.806.841 and all the patients involved in the research had access to the informed consent form. The diagnosis of diabetes was obtained through blood tests that test blood glucose levels, thus, before clinical evaluations, and 90 days after the periodontal treatment were performed fasting blood glucose tests. Healthy patients also underwent blood tests. After the anamnesis, periodontal clinical examination was performed by a previously trained and calibrated periodontist. Periodontal clinical parameters were realized. After periodontal therapy, all patients underwent further periodontal and laboratory blood tests. The data obtained were tabulated and received statistical treatment through the Anova and Chi square tests. There seems to be a relationship between type 2 diabetes and periodontal disease and studies that provide the implementation of therapy are essential for clarifying the relationship.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •diabetic patients with chronic periodontitis and Systemically healthy patients with chronic periodontitis

排除标准

  • •Patients who had any of the following characteristics were excluded from the study: use of orthodontic appliances, smoking, pregnancy or lactation, hepatitis or HIV infection or any other disease that compromises immune functions, immunosuppressive chemotherapy, antibiotics, phenytoin, calcium antagonists, cyclosporine or anti-inflammatory drugs one month before the initial consultation, use of oral contraceptives or hormone replacement, periodontal treatment in the 6 months prior to the start of the study.

研究组 & 干预措施

Diabetic group DG

Experimental

Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors

干预措施: Non-surgical periodontal treatment (Procedure)

No diabetic group NG

Active Comparator

Non-surgical periodontal treatment with scaling and root coronary planing, oral hygiene instructions and removal of biofilm retention factors

干预措施: Non-surgical periodontal treatment (Procedure)

结局指标

主要结局

blood test fasting blood glucose

时间窗: 90 days

blood tests were performed at baseline and 90 days after periodontal therapy

blood test for glycated hemoglobin

时间窗: 90 days

blood tests were performed at baseline and 90 days after periodontal therapy

次要结局

未报告次要终点

研究者

发起方
Universidade Metropolitana de Santos
申办方类型
Other
责任方
Principal Investigator
主要研究者

CAIO VINICIUS G. ROMAN TORRES

Professor

Universidade Metropolitana de Santos

研究点 (1)

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