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临床试验/NCT02886676
NCT02886676已完成4 期

Effect of Arthrospira Platensis (Spirulina) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant Levels in Chronic Periodontitis Subjects

Tatyasaheb Kore Dental College0 个研究点目标入组 70 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
70
主要终点
Superoxide dismutase (SOD)

研究概览

简要总结

Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease.

It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC) exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and leukotriene biosynthesis.

Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary antioxidants level in CP subjects.

Materials And Methods- The study was a randomized double-blind clinical and biochemical trial in which 70 subjects with CP in the age group of 40-55 years, reporting to Department of Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test Group (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals for 1 month and CG was not given any supplementary diet. SRP was done at baseline in TG and CG. Whole saliva sample was collected. Clinical and biochemical parameters will be recorded at baseline, 1 month & 3 months.

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, Investigator)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with CP (moderate and severe)as per CDC criteria
  • Patients without any known systemic diseases.

排除标准

  • Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
  • Subjects who have undergone periodontal treatment within six months of inception of study.
  • Tobacco habits in any form and alcoholics.
  • Pregnant and lactating women.

研究组 & 干预措施

Spirulina capsules and scaling & root planing

Experimental

Patients in test group will be provided with Spirulina capsules 2gm daily, after meals for 1 month

干预措施: Spirulina capsules (Drug)

Placebo capsules and scaling & root planing

Active Comparator

Patients in test group will be provided with placebo capsules after meals for 1 month

干预措施: Spirulina capsules (Drug)

结局指标

主要结局

Superoxide dismutase (SOD)

时间窗: 3 month

Malondialdehyde (MDA)

时间窗: 3 month

次要结局

  • Probing depth (PD)(3 month)
  • plaque index(3 month)
  • Gingival bleeding index(3 month)
  • Sulcus bleeding index (SBI)(3 month)
  • Clinical Attachment Level (CAL)(3 month)

研究者

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

Dr. Pradnya Rajendra Khatavkar

post graduate syudent

Tatyasaheb Kore Dental College

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