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

Study Overview
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Brief Summary
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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.

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Spirulina capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with CP (moderate and severe)as per CDC criteria 2007. Patients without any known systemic diseases. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirulina capsules and scaling & root planing<br>Patients in test group will be provided with Spirulina capsules 2gm daily, after meals for 1 month | Drug: Spirulina capsules<br>* Spirulina capsules 2gm daily for 1 month<br>|
| Active Comparator: Placebo capsules and scaling & root planing<br>Patients in test group will be provided with placebo capsules after meals for 1 month | Drug: Spirulina capsules<br>* Spirulina capsules 2gm daily for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superoxide dismutase (SOD) |  | 3 month | 
| Malondialdehyde (MDA) |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque index |  | 3 month | 
| Gingival bleeding index |  | 3 month | 
| Sulcus bleeding index (SBI) |  | 3 month | 
| Probing depth (PD) |  | 3 month | 
| Clinical Attachment Level (CAL) |  | 3 month |