Periodontitis Stage II
Conditions
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.
Interventions
OTHERPlacebo gel
A gel without active Spirulina components applied as a control intervention.
DIETARY_SUPPLEMENTSpirulina Gel
A conventional Spirulina gel formulation applied as a periodontal therapy.
DIETARY_SUPPLEMENTSpirulina Nanoparticles Gel
A novel Spirulina nanoparticles gel formulation applied as a periodontal therapy.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Probing Pocket Depth (PPD) | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Bone Density Improvement | at baseline and after 6 months | Changes in alveolar bone density measured using radiographic imaging techniques. |
| Biochemical Marker Levels | Measured at baseline, 1 month ,3 months, and 6 months | Reduction in inflammatory markers specifically Superoxide dismutase enzyme levels in gingival crevicular fluid. |
Countries
Egypt
Outcome results
None listed