Clinico microbiological evaluation of the efficacy of local delivery of Amoxicillin and Metronidazole Nanofibers as an adjunct to scaling and root planing in Periodontitis Stage II Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Microbiological parameters: Supra and subgingival micro flora will be assessed by aerobic and anaerobic bacterial culture in both the groups
研究概览
简要总结
Chronic periodontitis is an inflammatory disease caused by harmful bacteria in the mouth, leading to damage of the tissues supporting the teeth. The condition is common, affecting around 51% of adults globally, with severe cases impacting 19% of the population. Plaque buildup is the main cause, with bacteria like Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, and Fusobacterium nucleatum playing a key role. Treatment often includes antibiotics like amoxicillin and metronidazole, but rising antibiotic resistance is a concern. To address this, local drug delivery using nanotechnology has been explored, providing controlled release of antibiotics directly into the affected areas. This method can reduce side effects, improve patient compliance, and enhance treatment effectiveness. The combination of amoxicillin and metronidazole in nanofibers offers a promising solution to combat periodontitis and reduce antibiotic resistance, though more research is needed, especially in the Indian population.
AIM AND OBJECTIVE OF THE STUDY: - The purpose of this study is to evaluate the efficacy of local delivery of amoxicillin and metronidazole nanofibers as an adjunct to SRP have better clinical and microbiological out come when compared to SRP alone in treatment of stage II periodontitis patients
CLINICALPARAMETERS will be assessed at baseline,1month and 3 months. Plaque Index Gingival Index Probing Pocket Depth Clinical Attachment Level (CAL)
MICROBIOLOGICAL PARAMETERS are Supra and subgingival Plaque samples will be collected at baseline and at 1 month after
treatment for microbiological assessment.
In the treatment procedure, the test group will first undergo complete scaling and root planing followed by amoxicillin and metronidazole nanofibers will be placed in the periodontal pockets. The control group will complete ultrasonic scaling and root planing but no nanofibers will be applied. For the microbial assay, supra- and subgingival plaque samples will be collected from patients diagnosed with stage II periodontitis at baseline and again after 1 month using a sterile curette. These samples will be transported to the microbiology lab for aerobic and anaerobic bacterial culture analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 18 years to 50 years Patients diagnosed with periodontitis stage II Site specific criteria is Probing pocket depth greater than or equal to 5mm and less than 8mm.
排除标准
- •Chronic smokers Patients with any other systemic disorders Patients who are unwilling to participate in the study Pregnant and lactating mothers Patients allergic to amoxicillin and metronidazole.
结局指标
主要结局
Microbiological parameters: Supra and subgingival micro flora will be assessed by aerobic and anaerobic bacterial culture in both the groups
时间窗: Clinical parameters: Assessed at baseline, 1 month and 3 months | Microbiological parameters: Baseline and 1 month
Clinical parameters: PI(Plaque index),GI(Gingival index),PPD(Probing pocket depth),and CAL(Clinical attachment levvel) in test and control group
时间窗: Clinical parameters: Assessed at baseline, 1 month and 3 months | Microbiological parameters: Baseline and 1 month
次要结局
未报告次要终点