EFFECT OF PERIODONTAL INTERVENTION ON THE LEVELS OF N TERMINAL PRO BRAIN NATRIURETIC PEPTIDE IN GINGIVAL CREVICULAR FLUID IN DIABETIC AND NON-DIABETIC PATIENTS WITH PERIODONTITIS
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To evaluate the association between diabetes mellitus and cardiovascular disease as potential risk factors for periodontal disease
研究概览
简要总结
NT-ProBNP is a cardiovascular biomarker which is actively detected in periodontal diseases & SRP aids in the improvement in clinical parameters, which may be due to resolution of the inflammatory response and the cessation of periodontal destruction which makes a direct impact on this biomarker and reduces its potential pathogenicity and leads to their lowered concentrations in GCF and serum [1].
In addition diabetic patients have high cardiovascular morbidity and mortality. There are few studies aiming to clarify the role of this NT-ProBNP in diabetic patients. These have shown that in subjects with DM, NT-ProBNP is a direct predictor of adverse outcome and cardiovascular mortality [4].
In light of the above, this research aims to evaluate the role of NT-ProBNP in diabetic and non-diabetic patients with periodontitis before and after SRP [4].
This is a comparative, interventional study on diabetic and non-diabetic subjects (satisfying the inclusion and exclusion criteria) visiting OPD in the Dept of Periodontology, JSS Dental College And Hospital, Mysuru, JSS Hospital.
Blood investigation reports are obtained. Based on these reports, patients will be
categorized into 2 groups:
-
Diabetic patients
-
Non-diabetic patients
After complete oral examination, both the groups will be further categorized as periodontally compromised individuals.
Details such as demographics, socio-economic, medical information and personal history
will be recorded in a preformed case history proforma.
Periodontal examination –
-
Plaque index
-
Gingival index
-
Clinical Attachment Loss (CAL)
-
Probing Pocket Depth (PPD)
will be done using UNC-15 Probe.
Particulars regarding the diabetic status i.e., HbA1C percentage will be collected from the blood investigation reports in diabetic patients.
GCF will be collected using micropipettes and samples will be subjected to N Terminal Pro Brain Natriuretic Peptide (NT-ProBNP) test, which will be done in the Department of Biochemistry at JSS Medical College using ELISA kit.
These samples will be collected both before SRP and after SRP i.e., after a follow-up period of 3 months.
The data obtained will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients within the age 35-50 years
- •Duration of diabetic more than one year
- •Subjects with ≥ 18 completely erupted teeth
- •Subjects with presence of bleeding on probing
- •Probing pocket depth ≥ 5mm
- •Clinical attachment level ≥ 6mm.
排除标准
- •No evidence of systemic diseases other than diabetes as a risk factor for periodontitis
- •Atherosclerotic vascular disease (i.e., CVD, stroke and peripheral artery disease)
- •Arthritis/osteoporosis
- •History of periodontal intervention within the last 6 months
- •Anti-inflammatory and non-steroidal anti-inflammatory therapy within 3 months prior to periodontal assessment
- •Pregnancy 7.
结局指标
主要结局
To evaluate the association between diabetes mellitus and cardiovascular disease as potential risk factors for periodontal disease
时间窗: 3 months
次要结局
- To assess the clinical periodontal parameters, plaque index, gingival index, clinical attachment loss & probing pocket depth before & after scaling & root planing(3 months)
研究者
Dr Dakshina J
JSS Dental College and Hospital, Mysuru