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

Chronic Periodontitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886676
• Other study ID #: panu2511
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2016
• Last updated: August 31, 2016
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Tatyasaheb Kore Dental College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Spirulina capsules
Spirulina capsules 2gm daily for 1 month

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tatyasaheb Kore Dental College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superoxide dismutase (SOD)		3 month	Yes
Primary	Malondialdehyde (MDA)		3 month	Yes
Secondary	plaque index		3 month	Yes
Secondary	Gingival bleeding index		3 month	Yes
Secondary	Sulcus bleeding index (SBI)		3 month	Yes
Secondary	Probing depth (PD)		3 month	Yes
Secondary	Clinical Attachment Level (CAL)		3 month	Yes