Comparative evaluation of effect of Non surgical periodontal therapy on serum levels of DNA sensing inflammasomes Absent in Melanoma 2 (AIM2) Interferon gamma inducible protein (IFI16) Cytokine interleukin (IL18) in Stage III periodontitis with and without Type 2 Diabetes Mellitus an interventional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effect of NSPT on serum levels of DNA sensing inflammasomes AIM2, IFI-16, cytokine IL18 in Stage III periodontitis with and without T2DM.
研究概览
简要总结
This interventional study is conducted to compare and evaluate the effect of Non-surgical periodontal therapy on serum levels of DNA sensing inflammasomes Absent in Melanoma 2 (AIM2) Interferon γ inducible protein (IFI16) Cytokine interleukin (IL 18 ) in Stage III periodontitis with and without Type 2 Diabetes Mellitus .
The study will comprise of 90 patients, both males and females, visiting the Department of Periodontology and Implantology divided equally into three group Group I Periodontally healthy patients, presence of good oral hygiene with no visual signs of gingival inflammation bleeding on probing (BOP) in < 1 probing depth(PPD) ≤3 mm Group II Stage III periodontitis with a minimum of 15 teeth having PPD and clinical attachment level (CAL) of ≥4 mm. Group III Stage III periodontitis with T2DM (type 2 diabetes mellitus) PPD and CAL ≥ 4mm. HbA1c levels in between 6.5 % to 8. Informed consent will be taken from the patients who wish to enroll in the study. For Group I blood samples will be obtained at baseline. For Group II and Group III blood samples will be obtained at baseline and 6 weeks after Non Surgical Periodontal Therapy. Comparison and evaluation of the effect of Non-surgical periodontal therapy on serum levels of DNA sensing inflammasomes Absent in Melanoma 2 (AIM2) Interferon γ inducible protein (IFI16) Cytokine interleukin (IL 18 ) in Stage III periodontitis with and without Type 2 Diabetes Mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Group I Periodontally healthy patients presence of good oral hygiene with no visual signs of gingival inflammation bleeding on probing(BOP) in less than equal to 1 probing depth(PPD) less than equal to 3 mm Group II Stage III periodontitis with a minimum of 15 teeth having PPD and clinical attachment level of greater than equal to four mm.
- •Group III Stage III periodontitis with T2DM PPD and CAL greater than equal to four mm.
- •HbAonec levels in between 6.5 to 8 percentage.
排除标准
- •1 Patients who have undergone any periodontal therapy in the past 6 months 2 Patients with systemic diseases other than diabetes 3History of any medication including antibiotic treatment within the previous 3 months or regular use of specific drugs known to affect periodontal tissues 4 Pregnant women and lactating mothers.
结局指标
主要结局
To evaluate and compare the effect of NSPT on serum levels of DNA sensing inflammasomes AIM2, IFI-16, cytokine IL18 in Stage III periodontitis with and without T2DM.
时间窗: at baseline and 6 weeks
次要结局
- To evaluate and compare PPD CAL and PISA in periodontally healthy Stage III periodontitis with and without T2DM patients.(To evaluate and compare the serum levels of DNA sensing inflammasomes AIM2 IFI-16 cytokine IL18 Random blood sugar (RBS) HbA1c in periodontally healthy Stage III periodontitis with and without T2DM patients.)
研究者
Dr Radhika Rathi
Ranjeet Deshmukh Dental College and Research Centre