Evaluation of Salivary Interleukin-6 levels in Diabetic patients with periapical lesion-An In Vivo Study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To evaluate and compare the levels of IL-6 before and after the root canal treatment in healthy patients
研究概览
简要总结
This study will be done to evaluate the interleukin- 6 levels in the diabetic patients with periapical lesion. The forthcoming in vivo study will be carried out within the Department of Conservative Dentistry and Endodontics at ITS Dental College and Research Centre in Greater Noida, Uttar Pradesh. A total number of 60 patients including healthy and type 2 diabetes mellitus patients of age 20-65 years reporting to the OPD of Department of Conservative Dentistry will be selected as per the inclusion and exclusion criteria. Medical and dental history will be recorded for patients reporting to the Department of Conservative and Endodontics and patients will be selected according to the inclusion criteria in the study. Included patients will be informed about the study and explained in detail about the procedure of the study and requirement for the same. A preoperative radiograph will be taken to assess the size of Periapical radiolucency which should be less than 4mm. RBS levels will be checked using glucometer when the patient will report in the OPD. OPG will be done to evaluate the periodontal health.
They will be divided into 4 groups.
Group A- 15 patients with type 2 diabetes mellitus (patients who are on oral medications with fasting plasma less than 100 mg/dl) with periapical lesion measuring not more than 4mm
Group B- 15 patients with type 2 diabetes mellitus (patients who are on oral medications with fasting plasma less than 100 mg/dl) without periapical lesion.
Group C – 15 healthy patients having periapical radiolucency measuring not more than 4mm diameter
Group C - 15 healthy patients with vital (healthy) tooth indicated for intentional root canal treatment.
Saliva will be collected before the treatment.
Saliva will be collected after BMP, on the day of obturation.
Saliva will be tested through ELISA for the interleukin 6 levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender and age between 20-65 years
- •Patients with type 2 diabetes mellitus with RBS levels not more than 160 mg/dl
- •Patient with symptomatic/ asymptomatic irreversible pulpitis
- •Patients having healthy periodontal status
- •Patients consenting to participate in the study.
- •Patients with caries will be restored prior to the study.
排除标准
- •Patients having other systemic diseases such as hypertension, cancer, Obesity, heart diseases, Alzheimer’s disease, pregnant women
- •Any use of medicaments such as anti-inflammatory or antibiotics in past 3 months.
- •Periapical lesion more than 4mm 4.Teeth with periodontal infections
- •Patients having habits like smoking, drinking alcohol etc.
结局指标
主要结局
1. To evaluate and compare the levels of IL-6 before and after the root canal treatment in healthy patients
时间窗: Baseline(on the day of onset of trial) and after 1 week(post operative)
2. To evaluate and compare the levels of IL-6 before and after the root canal treatment in diabetic patients
时间窗: Baseline(on the day of onset of trial) and after 1 week(post operative)
次要结局
- To find the effect on IL-6 due to endodontic lesions(Baseline(on the day of onset of trial) & after 1 week(post operative))
研究者
Dr Rashi Bansal
ITS Dental College Hospital And Research Centre, Greater Noida