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

NCT02886676 | Completed Phase 4

• 1 other identifier: panu2511
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (2)

• Superoxide dismutase (SOD)

  3 month

• Malondialdehyde (MDA)

  3 month

Secondary Outcomes (5)

• 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

Study Arms (2)

Spirulina capsules and scaling & root planing

EXPERIMENTAL

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

Drug: Spirulina capsules

Placebo capsules and scaling & root planing

ACTIVE COMPARATOR

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

Drug: Spirulina capsules

Interventions

Spirulina capsules DRUG

Spirulina capsules 2gm daily for 1 month

Placebo capsules and scaling & root planing; Spirulina capsules and scaling & root planing

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post graduate syudent

Study Record Dates

• First Submitted: August 27, 2016
• First Posted: September 1, 2016
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08