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Completed

NCT Number: NCT02886676

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

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spirulina capsules

Drug

Spirulina capsules 2gm daily for 1 month

Primary outcomes

  1. Superoxide dismutase (SOD)

    Time frame: 3 month

  2. Malondialdehyde (MDA)

    Time frame: 3 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tatyasaheb Kore Dental College

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2016
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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