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

NCT ID: NCT02886676

Last Updated: 2016-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Spirulina capsules and scaling & root planing

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

Group Type EXPERIMENTAL

Spirulina capsules

Intervention Type DRUG

Spirulina capsules 2gm daily for 1 month

Placebo capsules and scaling & root planing

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

Group Type ACTIVE_COMPARATOR

Spirulina capsules

Intervention Type DRUG

Spirulina capsules 2gm daily for 1 month

Interventions

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Spirulina capsules

Spirulina capsules 2gm daily for 1 month

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tatyasaheb Kore Dental College

OTHER

Sponsor Role lead

Responsible Party

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Dr. Pradnya Rajendra Khatavkar

post graduate syudent

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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panu2511

Identifier Type: -

Identifier Source: org_study_id

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