Effects of Non-surgical Periodontal Therapy on the Glycemic Variability of Periodontal Patients Affected by Type I Diabetes. a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin (HbA1c)
研究概览
简要总结
Current evidence suggests a bidirectional association between periodontitis and diabetes. Periodontal therapy improves short term HbA1c levels and is safe to perform. Most studies are focused on type 2 Diabetes. Literature about the correlation between periodontitis and type 1 diabetes is scarce, since no randomized clinical trials have been performed.
The objective of the present clinical investigation is to evaluate the effects of nonsurgical treatment of periodontal disease on glycemic variability in patients with type 1 diabetes (T1DM). The hypothesis is that nonsurgical periodontal therapy affects glycemic variability in terms of time spent in hyperglycemia.
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
- Triple (Care Provider, Investigator, 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
- 否
入选标准
- •Diagnosis of Type 1 diabetes
- •Patients under treatment in the department of Diabetology of AOU Careggi having a microinfusor for continuous subcutaneous insulin infusion (CSII) and a Flash Glucose Monitoring (FGM) device
- •Diagnosis of periodontitis (all stages and grades)
排除标准
- •Contraindications for non-surgical periodontal therapy
- •Pregnancy
- •History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)
研究组 & 干预措施
Test
Patients receiving non-surgical periodontal treatment within 1 week from enrollment.
干预措施: Non-surgical periodontal therapy (Procedure)
Control
Patients receiving non-surgical periodontal treatment 6 months after the enrollment.
干预措施: Non-surgical periodontal therapy (Procedure)
结局指标
主要结局
Glycated hemoglobin (HbA1c)
时间窗: 6 months after the non-surgical periodontal treatment
Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).
次要结局
- Standard Deviation (SD) of glycaemia(6 months after the non-surgical periodontal treatment)
- Glucose coefficient of variability (CV)(6 months after the non-surgical periodontal treatment)
研究者
Dr. Francesco Cairo
Prof.
University of Florence