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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Reduction in Probing Pocket Depth (PPD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with good systemic health.
- •Patients who can maintain good oral hygiene.
- •Attachment loss 3-4 mm and probing pocket depth ≤ 5mm.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Placebo gel (Other)
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.
干预措施: Spirulina Gel (Dietary Supplement)
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.
干预措施: Spirulina Nanoparticles Gel (Dietary Supplement)
结局指标
主要结局
Reduction in Probing Pocket Depth (PPD)
时间窗: 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.
次要结局
- Radiographic Bone Density Improvement(at baseline and after 6 months)
- Biochemical Marker Levels(Measured at baseline, 1 month ,3 months, and 6 months)
研究者
Mohamed Samir Mohamed Ahmed Algarf
B.D.S. (2017) Misr University for Science and Technology
Kafrelsheikh University