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

Phase 4

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Spirulina capsules

• Registration Number: NCT02886676
• Lead Sponsor: Tatyasaheb Kore Dental College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-08
• Study First Submitted: 2016-08-27
• Study First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Study First Posted: 2016-09-01
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Subjects with CP (moderate and severe)as per CDC criteria 2007.
2. Patients without any known systemic diseases.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo capsules and scaling & root planing	Spirulina capsules	Patients in test group will be provided with placebo capsules after meals for 1 month
Spirulina capsules and scaling & root planing	Spirulina capsules	Patients in test group will be provided with Spirulina capsules 2gm daily, after meals for 1 month

Primary Outcome Measures

Name	Time	Method
Superoxide dismutase (SOD)	3 month
Malondialdehyde (MDA)	3 month

Secondary Outcome Measures

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