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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Spirulina capsules

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tatyasaheb Kore Dental College

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 27, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: panu2511