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

Kafrelsheikh University

Status: Invitation-only

Conditions: Periodontitis Stage II

Treatments: Dietary Supplement: Spirulina Nanoparticles Gel; Other: Placebo gel; Dietary Supplement: Spirulina Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06699654

KFSIRB200-68

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 3 patient groups, including a placebo group

Group I (control group)

Placebo Comparator group

Description:

Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth plus placebo gel instillation in the pocket.

Treatment:

Other: Placebo gel

Group II (experimental I)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Spirulina Gel

Group III (experimental II)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Spirulina Nanoparticles Gel