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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Spirulina capsules
Sponsored by
Tatyasaheb Kore Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Spirulina capsules and scaling & root planing

    Placebo capsules and scaling & root planing

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Superoxide dismutase (SOD)
    Malondialdehyde (MDA)

    Secondary Outcome Measures

    plaque index
    Gingival bleeding index
    Sulcus bleeding index (SBI)
    Probing depth (PD)
    Clinical Attachment Level (CAL)

    Full Information

    First Posted
    August 27, 2016
    Last Updated
    August 31, 2016
    Sponsor
    Tatyasaheb Kore Dental College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02886676
    Brief Title
    Effect of Arthrospira Platensis (Spirulina) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant Levels in Chronic Periodontitis Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tatyasaheb Kore Dental College

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spirulina capsules and scaling & root planing
    Arm Type
    Experimental
    Arm Description
    Patients in test group will be provided with Spirulina capsules 2gm daily, after meals for 1 month
    Arm Title
    Placebo capsules and scaling & root planing
    Arm Type
    Active Comparator
    Arm Description
    Patients in test group will be provided with placebo capsules after meals for 1 month
    Intervention Type
    Drug
    Intervention Name(s)
    Spirulina capsules
    Intervention Description
    Spirulina capsules 2gm daily for 1 month
    Primary Outcome Measure Information:
    Title
    Superoxide dismutase (SOD)
    Time Frame
    3 month
    Title
    Malondialdehyde (MDA)
    Time Frame
    3 month
    Secondary Outcome Measure Information:
    Title
    plaque index
    Time Frame
    3 month
    Title
    Gingival bleeding index
    Time Frame
    3 month
    Title
    Sulcus bleeding index (SBI)
    Time Frame
    3 month
    Title
    Probing depth (PD)
    Time Frame
    3 month
    Title
    Clinical Attachment Level (CAL)
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects with CP (moderate and severe)as per CDC criteria 2007. Patients without any known systemic diseases. Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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