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OpenTrials
Enrolling by Invitation

NCT Number: NCT06699654

"Comparison of Spirulina Gels for Treating Stage II Grade B Periodontitis"

This randomized controlled clinical study investigates the effectiveness of Spirulina gel and Spirulina nanoparticles gel in treating Stage II Grade B periodontitis. The research aims to compare the two formulations in terms of clinical, radiological, and biochemical outcomes, such as pocket depth reduction, alveolar bone density improvement, and inflammatory marker levels. The study seeks to provide insights into the potential of Spirulina-based therapies for enhancing periodontal health.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doctor Mohamed Samir Periodontal and Implantology Clinic

El-Sheikh Zayed City, Cairo Governorate, 12573, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with good systemic health.
  • Patients who can maintain good oral hygiene.
  • Attachment loss 3-4 mm and probing pocket depth ≤ 5mm. Exclusion criteria for this study include: ·
  • Any systemic disease that affects the periodontium. ·
  • Pregnant, postmenopausal women. ·
  • People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.
  • People who use mouth washes regularly ·
  • Participation in other clinical trials.

Treatment and study plan

Placebo gel

Other

A gel without active Spirulina components applied as a control intervention.

Spirulina Gel

Dietary Supplement

A conventional Spirulina gel formulation applied as a periodontal therapy.

Spirulina Nanoparticles Gel

Dietary Supplement

A novel Spirulina nanoparticles gel formulation applied as a periodontal therapy.

Primary outcomes

  1. Reduction in Probing Pocket Depth (PPD)

    Time frame: at baseline, 1 month , 3 months, 6 months

    The mean reduction in probing pocket depth in millimeters (mm) at periodontal sites treated with Spirulina gel and Spirulina nanoparticles gel.

Secondary outcomes

  1. Radiographic Bone Density Improvement

    Time frame: at baseline and after 6 months

    Changes in alveolar bone density measured using radiographic imaging techniques.

  2. Biochemical Marker Levels

    Time frame: Measured at baseline, 1 month ,3 months, and 6 months

    Reduction in inflammatory markers specifically Superoxide dismutase enzyme levels in gingival crevicular fluid.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Comparative Study Between Spirulina Gel and Spirulina Nanoparticles Gel for Treatment of Stage II Grade B Periodontitis: Randomized Control Clinical Study with Radiological and Biochemical Assessment

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Feb 11, 2025

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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