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临床试验/NCT03599401
NCT03599401已完成不适用

Comparison of Effectiveness of Low Dose Aspirin Vs Omega 3 Fatty Acids as Adjuvants to Non-surgical Periodontal Therapy in Type II Diabetic Patients With Chronic Periodontitis

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Change in Plasma Pentraxin 3 levels

研究概览

简要总结

The main aim and objective of this study is to compare the effectiveness of low dose aspirin vs omega 3 fatty acids as adjuvants to non-surgical periodontal therapy and also to evaluate the levels of pentraxin 3 and glycosylated haemoglobin in diabetic patients with chronic periodontitis

详细描述

There is an established bi-directional relationship between diabetes mellitus and periodontitis. Periodontitis causes systemic inflammation by the entry of oral pathogens and their virulence factors that adversely affect diabetic control in terms of elevated HbA1c levels.

Host modulatory therapy (HMT) is a strategy prescribed as an adjunct to conventional periodontal treatment by downregulating inflammation and promoting protective or regenerative responses. Different drugs have been evaluated as HMT including NSAIDS, Doxycycline, Bisphosphonates.

Aspirin has the unique position as HMT drug. It inhibits prostanoid production and induces 15- epi- lipoxins which are bioactive than native lipoxins.

Omega 3 fatty acids including Docosahexaenoic acid and Eicosapentaenoic acid due to their anti-inflammatory, antithrombotic, hypolipidemia and vasodilator effect, reduce the inflammatory mediators to levels of healthy tissues.

Pentraxins(PTX3) are classic acute phase proteins. They are a superfamily of evolutionarily conserved proteins considered to be the markers of acute phase inflammation. PTX3 is also known as TNF stimulated gene. It is produced abundantly in periodontal tissue by neutrophils, fibroblasts, monocytes and epithelial cells. The plasma levels of PTX3 is raised in inflammatory conditions. Hence it is taken as a biomarker.

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
Double (Participant, Outcomes Assessor)

盲法说明

Sealed Envelopes

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Type II Diabetes
  • Patients with Chronic periodontitis.
  • Clinical attachment loss ≥ 4 mm
  • Probing depths ≥ 5mm.
  • 14 teeth should be present
  • Diabetic patients having HbA1C levels ≥ 6%

排除标准

  • Pregnant and lactating women
  • Patients with any auto immune or systemic disorder other than type II Diabetes
  • Use of Medicines or antibiotic 3 months before
  • History of periodontal treatment within 12 months
  • Suspected intolerance to Aspirin

研究组 & 干预措施

Aspirin Group (Group I)

Active Comparator

14 Patients in Group I underwent scaling and root planing using ultrasonic scalers after which 75 mgms of Aspirin was administered orally, once daily for 3 months

干预措施: Scaling and root planing (Other)

Omega 3 Fatty acid Group (Group II)

Active Comparator

14 Patients in Group II were given 500 mgms of Omega 3 Fatty Acid orally, twice daily for 3 months after scaling and root planing using ultrasonic scalers.

干预措施: Scaling and root planing (Other)

Placebo Group (Group III)

Placebo Comparator

14 Patients in Group III was given Placebo, which was administered orally, twice daily for 3 months after scaling and root planing using ultrasonic scalers.

干预措施: Scaling and root planing (Other)

结局指标

主要结局

Change in Plasma Pentraxin 3 levels

时间窗: Base line and 3 months after scaling and root planning

Blood samples were collected by venepuncture of anti-cubital vein. 1ml of blood was collected. 1ml blood was subjected to centrifugation at 3000rpm for 10 min. The supernatant straw colored fluid (plasma) was separated into storage vial for plasma pentraxin 3

Change in Glycosylated Hemoglobin levels

时间窗: Base line and 3 months after scaling and root planning

Blood samples were collected by venepuncture of anti-cubital vein. 1ml of blood was collected and was used for glycosylated hemoglobin (HbA1c) estimation

次要结局

  • Change in Gingival Index(Base line and 3 months after scaling and root planning)
  • Change in Pocket Probing Depth(Base line and 3 months after scaling and root planning)
  • Change in Clinical attachment level(Base line and 3 months after scaling and root planning)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rampally Prathyusha

Student

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

研究点 (2)

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