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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

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ClinicalTrials.gov Identifier: NCT02886676
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Pradnya Rajendra Khatavkar, Tatyasaheb Kore Dental College

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Spirulina capsules Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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




Primary Outcome Measures :
  1. Superoxide dismutase (SOD) [ Time Frame: 3 month ]
  2. Malondialdehyde (MDA) [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. plaque index [ Time Frame: 3 month ]
  2. Gingival bleeding index [ Time Frame: 3 month ]
  3. Sulcus bleeding index (SBI) [ Time Frame: 3 month ]
  4. Probing depth (PD) [ Time Frame: 3 month ]
  5. Clinical Attachment Level (CAL) [ Time Frame: 3 month ]


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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Dr. Pradnya Rajendra Khatavkar, post graduate syudent, Tatyasaheb Kore Dental College
ClinicalTrials.gov Identifier: NCT02886676     History of Changes
Other Study ID Numbers: panu2511
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases