Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis: a Randomized-controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pulse Wave Velocity carotid-femoral (PWV-CF)
研究概览
简要总结
A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease.
详细描述
A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease.
90 patients: 30 with peri-implantitis, 30 with peri-implant mucositis and 30 healthy controls and without periodontitis history.
All the patients are assessed for clinical, periodontal, blood and non-invasive ultrasound cardiovascular parameters. Measurements are taken before and after initial periodontal treatment in the peri-implantitis/peri-implant mucositis subjects.
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 (Participant, Care Provider, Investigator)
盲法说明
Sealed envelopes
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria.
排除标准
- •Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- •Pregnancy.
- •Cardiovascular Diseases.
- •PERI-IMPLANT MUCOSITIS GROUP
- •Inclusion Criteria:
- •Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria.
- •Exclusion Criteria:
- •Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- •Pregnancy.
- •Cardiovascular Diseases.
- •HEALTHY GROUP
- •Inclusion Criteria:
- •Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.
- •Exclusion Criteria:
- •Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- •Pregnancy.
- •Cardiovascular Diseases.
结局指标
主要结局
Pulse Wave Velocity carotid-femoral (PWV-CF)
时间窗: 8 weeks
The speed of pulse wave propagation between carotid-femoral sites
Pulse Wave Velocity carotid-femoral (PWV-CR)
时间窗: 8 weeks
The speed of pulse wave propagation between carotid-radial sites
Carotid Intima-Media Thickness (CIMT)
时间窗: 8 weeks
The thickness of the carotid intima and media
Distensibility Coefficient (DC)
时间窗: 8 weeks
The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular.
Advanced Glycation End products (AGEs)
时间窗: 8 weeks
A group of endogenous heterogeneous compounds that are constantly formed under physiological conditions with prooxidant and cytotoxic properties. Measurements are performed by fluorescence spectroscopy technique.
次要结局
未报告次要终点
研究者
Gaetano Isola
Researcher
University of Catania