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

August 31, 2016 updated by: Dr. Pradnya Rajendra Khatavkar, Tatyasaheb Kore Dental College

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 51 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 3 month
3 month
Malondialdehyde (MDA)
Time Frame: 3 month
3 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tatyasaheb Kore Dental College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • panu2511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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