Effect of Periodontal Treatment on Metabolic Control in Patients with Type-2 Diabetes Mellitus Treated in the Cardiovascular Healt Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HbA1c (The glycated hemoglobin)
研究概览
简要总结
The objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis.
Non-surgical periodontal treatment and the application of a quality of life survey will be performed and then controls will be carried out for 1 year.
详细描述
The aim of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of HbA1c levels in adult patients with type 2 diabetes mellitus who are users of the Cardiovascular Health Program and also to measure their quality of life by means of a survey OHIP-14sp.
Non-surgical periodontal treatment and subsequent follow-up of periodontal clinical parameters and HbA1c values at 3, 6, 9 and 12 months will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1a. Patients enrolled in the PSCV with a diagnosis of type 2 diabetes mellitus and who, in turn, have a glycated hemoglobin ≥ 7% (during the last 6 months).
- •1b. Patients with a diagnosis of periodontitis (≥ 2 non-adjacent teeth with detectable clinical interproximal attachment loss or, attachment loss ≥ 3mm with depth to probing ≥ 3mm on free faces of ≥ 2 teeth, where the attachment loss was not attributed to non-periodontal causes (Papapanou et al., 2018)).
排除标准
- •2a. Patients who have received periodontal treatment during the last year.
- •2b. Pregnancy/lactation, because they are under treatment under the Explicit Health Guarantee "Oral and Integral Health of Pregnant Women".
- •2c. Therapy with antibiotics and/or non-steroidal anti-inflammatory drugs (NSAIDs) in the last 6 months prior to the study.
研究组 & 干预措施
Patients with periodontitis and Diabetes Mellitus type 2
There will be a group of patients to intervene, who present periodontitis and Diabetes Mellitus type 2.
干预措施: Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey. (Procedure)
结局指标
主要结局
HbA1c (The glycated hemoglobin)
时间窗: 13 months
The glycated hemoglobin (HbA1c) is a blood test that measures the average blood glucose level over the past two to three months, expressed as a percentage. It is used to diagnose diabetes and prediabetes, and to monitor diabetes treatment. A higher percentage indicates poorer glycemic control. The value will be measured at the beginning of periodontal treatment and during maintenance therapy at 3, 6, 9 and 12 months.
次要结局
- Patient self-reported quality of life.(13 months)
- Probing deep in periodontal evaluation(13 months)
- Clinical attachment loss in periodontal evaluation(13 months)
- bleeding of probing in periodontal evaluation(13 months)
研究者
MELISA VERA
Principal Investigator, Clinical Periodontist, Universidad de Chile
University of Chile