Effect of Nonsurgical Periodontal Treatment on Carotid Intima Media Thickness (c - IMT) and Cardiovascular Risk Biomarkers in stage II, III Periodontitis at Risk of Atherosclerotic Cardiovascular Disease (ASCVD) – A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- 1. Carotid Intima Media Thickness (c-IMT)
研究概览
简要总结
India has one of the highest burdens of cardiovascular disease (CVD) worldwide. According to the World Health Organization, India accounts for one-fifth of these deaths worldwide especially in younger population. CVDs strike Indians a decade earlier than the western population. Chronic infections accelerate vascular inflammation and promote thrombosis of vascular vessels and are believed to be a secondary pathogenic pathway. Periodontitis is an infectious disease resulting in inflammation within the supporting tissues of teeth resulting in progressive attachment and alveolar bone loss. Overall prevalence of Periodontitis is 47.2% in Indian population. There are two reasons why Periodontitis and CVD are believed to be related. Firstly, the levels of systemic inflammation increase when moderate or severe periodontitis is present. Secondly, the periodontal bacteria may invade the damaged periodontal tissue, enter the bloodstream and further invade the cardiovascular system. There is evidence for a strong association between Periodontitis and CVD, but a direct causal relationship has not been established. There is scarcity of information about whether periodontal treatment is able to reduce the risk for cardiovascular disease in periodontitis subjects. Hence, this Randomized controlled trial is designed to test the effect of nonsurgical periodontal treatment on Carotid Intima media thickness (c - IMT) and cardiovascular risk biomarkers viz., Endocan, Platelet indices and Highly sensitive C- Reactive Protein (hs-CRP) in subjects diagnosed with stage II or stage III Periodontitis at risk or not at risk of Atherosclerotic Cardiovascular Disease (ASCVD), with follow-up time of at least one year. The patients considered at risk for ASCVD will be borderline cholesterol level, pre – diabetes and pre – hypertension subjects. In addition, we will also see changes in Blood Pressure (BP) in Prehypertensive, Lipid Profile in Borderline - high cholesterol, blood glucose level in prediabetic subjects. Also, periodontal parameters will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Stage II or Stage III Periodontitis subjects not at risk of ASCVD with CIMT ≥ 0.6 mm or elevated cardiovascular risk biomarkers. Stage II Periodontitis – Moderate Periodontitis with Clinical Attachment Loss of 3 to 4 mm, Maximum probing depth ≤5 mm, mostly horizontal bone loss in Coronal third (15% to 33%). Extent and distribution – Generalized. Stage III Periodontitis.
- •Severe Periodontitis with Clinical Attachment Loss of ≥5 mm, Radiographic bone loss extending to mid-third of root and beyond, Probing depth ≥6 mm, Vertical bone loss ≥3 mm, Furcation involvement Class II or III, Moderate ridge defect. Extent and distribution – Generalized.
- •Stage II or Stage III Periodontitis subjects at risk of ASCVD with Borderline.
- •high cholesterol or pre – hypertensive or prediabetic with CIMT ≥ 0.6 mm or elevated cardiovascular risk biomarkers.
- •Have at least 16 natural teeth excluding third molars. Prehypertensive/ High – normal Blood Pressure (BP).
- •Subjects with systolic BP of 130-139 mmHg or diastolic BP of 85-89 mmHg.
- •Borderline.
- •high cholesterol.
- •Total serum cholesterol levels between 200 – 239 mg/dl or LDL (Low Density Lipoprotein) levels between 130 – 159 mg/dl.
- •Pre-diabetes.
- •Subjects with prediabetes are defined by the presence of Fasting Plasma Glucose (FPG) 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) Impaired Fasting Glucose (IFG) and/or HbA1c 39 – 46 mmol/ mol (5.7-6.4 %).
- •Provide informed consent and willingness to cooperate with the study protocol.
排除标准
- •Treatment with antihypertensive, antilipemic, antiarrhythmic, anti-platelet therapy and other cardiovascular drugs.
- •Systemic diseases such as HIV/AIDS, liver disease, chronic renal failure, tuberculosis, autoimmune diseases, any mental disability.
- •Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, AV blockade, peripheral vascular disease, and cerebrovascular accident.
- •Subjects with hypercholesteremia, Diabetes Mellitus, Obesity, Smokers.
- •Oral/ Dental infections other than periodontal infections.
- •Subjects who received periodontal treatment within the last 6 months.
- •Subjects who require antibiotic prophylaxis before examination or treatment.
- •Pregnant or lactating females.
结局指标
主要结局
1. Carotid Intima Media Thickness (c-IMT)
时间窗: Baseline, 6 months and 12 months
2. Endocan/ Endothelium Specific Molecule – 1 (ESM-1)
时间窗: Baseline, 6 months and 12 months
3. Platelet Indices
时间窗: Baseline, 6 months and 12 months
4. Highly sensitive C-reactive protein (hs - CRP)
时间窗: Baseline, 6 months and 12 months
in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.
时间窗: Baseline, 6 months and 12 months
次要结局
- Blood Pressure (BP) in Prehypertensive Stage II or Stage III Periodontitis subjects(Baseline, 3, 6, 9 and 12 months)
- Lipid Profile in Borderline - high cholesterol Stage II or Stage III Periodontitis subjects(Baseline, 3,6,9 and 12 months)
- blood glucose level in prediabetic Stage II or Stage III Periodontitis subjects(Baseline, 3,6,9 and 12 months)
- Bleeding on Probing (BOP)in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.(Baseline, 3,6,9 and 12 months)
- Plaque Index (PlI)in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.(Baseline, 3,6,9 and 12 months)
- Gingival Index (GI) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.(Baseline, 3,6,9 and 12 months)
- Probing Pocket Depth (PPD) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.(Baseline, 3,6,9 and 12 months)
- Clinical Attachment Level (CAL) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.(Baseline, 3,6,9 and 12 months)
- Gingival Recession (GR) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.(Baseline, 3,6,9 and 12 months)
研究者
Pallavi Sumit Sonpimpale
Government Dental College and Hospital, Nagpur