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
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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.
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
NCT ID
NCT02886676
First Posted
August 27, 2016
Last Updated
August 31, 2016
Sponsor
Tatyasaheb Kore Dental College
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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