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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Periodontitis Stage II
• Intervention / Treatment: Other: Placebo gel; Dietary supplement: Spirulina Gel; Dietary supplement: Spirulina Nanoparticles Gel

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • El-Sheikh Zayed City, Cairo, Egypt, 12573
      • Doctor Mohamed Samir Periodontal and Implantology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group I (control group); Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth plus placebo gel instillation in the pocket.	Other: Placebo gel; A gel without active Spirulina components applied as a control intervention.
Active Comparator: Group II (experimental I); Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina gel instillation in the deepest selected periodontal pocket after drying the area around it.	Dietary supplement: Spirulina Gel; A conventional Spirulina gel formulation applied as a periodontal therapy.
Experimental: Group III (experimental II); Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina nanogel instillation in the deepest selected periodontal pocket after drying the area around it.	Dietary supplement: Spirulina Nanoparticles Gel; A novel Spirulina nanoparticles gel formulation applied as a periodontal therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Probing Pocket Depth (PPD)	The mean reduction in probing pocket depth in millimeters (mm) at periodontal sites treated with Spirulina gel and Spirulina nanoparticles gel.	at baseline, 1 month , 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Bone Density Improvement	Changes in alveolar bone density measured using radiographic imaging techniques.	at baseline and after 6 months
Biochemical Marker Levels	Reduction in inflammatory markers specifically Superoxide dismutase enzyme levels in gingival crevicular fluid.	Measured at baseline, 1 month ,3 months, and 6 months

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Study Director: Enas Elgendy, Prof.Dr, Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): October 24, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: KFSIRB200-68

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No