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

NCT06699654 | Enrolling By Invitation

• 1 other identifier: KFSIRB200-68
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis Stage II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Radiographic Bone Density Improvement

  at baseline and after 6 months

• Biochemical Marker Levels

  Measured at baseline, 1 month ,3 months, and 6 months

Study Arms (3)

Group I (control group)

PLACEBO COMPARATOR

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

Group II (experimental I)

ACTIVE COMPARATOR

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

Group III (experimental II)

EXPERIMENTAL

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

Interventions

Placebo gel OTHER

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

Group I (control group)

Spirulina Gel DIETARY_SUPPLEMENT

A conventional Spirulina gel formulation applied as a periodontal therapy.

Group II (experimental I)

Spirulina Nanoparticles Gel DIETARY_SUPPLEMENT

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

Group III (experimental II)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with good systemic health.
• Patients who can maintain good oral hygiene.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Doctor Mohamed Samir Periodontal and Implantology Clinic

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

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Enas Elgendy, Prof.Dr

  Kafrelsheikh University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S. (2017) Misr University for Science and Technology

Model Details: Participants are randomly assigned to one of three arms: Spirulina Gel, Spirulina Nanoparticles Gel, or control. The interventions are administered over a defined period with radiological and biochemical assessments conducted at baseline and post-treatment.

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 21, 2024
• Study Start: October 21, 2024
• Primary Completion: October 24, 2024
• Study Completion: May 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2024-12

Locations

EG (1)