Comparing Thermosensitive and Non-Thermosensitive Chitosan gels in treating periodontal pockets and their effect on Salivary Pyruvate kinase levels in age matched men and women: a split-mouth clinical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- 1. What is the comparative performance of chitosan gels with thermosensitive properties versus those without them in managing periodontal pockets?
研究概览
简要总结
Periodontitis is influenced by the accumulation of dysbiotic subgingival biofilm, which amplifies the immune response. Various enzymes produced by the body contribute to periodontal diseases and can be utilized to monitor disease progression and assess the effectiveness of periodontal therapy. These enzymes reflect metabolic changes in the gingiva and periodontium, making them useful for diagnosing disease activity. As these enzymes are secreted into bodily fluids like saliva and gingival crevicular fluid (GCF), these fluids can serve as diagnostic mediators.
pyruvate kinase (PK) being one of the enzymes identified in periodontal disease. PK plays a significant role in the development of periodontitis due to the increased metabolic demands of immune cells. It also modulates the production of pro-inflammatory cytokines, thereby influencing the progression of periodontal disease.
Antimicrobial polymers, particularly chitosan, emerge as potential treatments for oral diseases. Chitosan has various biological properties, including antibacterial, anti-inflammatory, and regenerative effects. This drug is available in various forms for local drug deliveries. Thermosensitive chitosan hydrogels, which transition from liquid to gel at body temperature, are being explored for controlled drug delivery and periodontal therapy. This study aims to evaluate different chitosan formulations for their effectiveness in treating periodontitis and their impact on pyruvate kinase levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy.
- •Patients who have not received periodontal therapy within 6 months.
- •Periodontal pockets with 4-7mm.
- •No antimicrobials for 1 month prior to the study.
排除标准
- •Presence of other systemic disorder, genetic disorders, and diseases which will Affect periodontal health.
- •Patients with Acute oral disease.
- •Smokers and tobacco chewers and alcoholics Patient who are allergic to drugs.
- •Pregnant and lactating women.
- •Patients who do not comply to oral hygiene instructions and recall maintenance.
- •Patients who are medically and mentally challenged.
结局指标
主要结局
1. What is the comparative performance of chitosan gels with thermosensitive properties versus those without them in managing periodontal pockets?
时间窗: BASELINE TO 6 MONTHS
2.How do chitosan gels impact the levels of pyruvate kinase (PK) enzyme in saliva?
时间窗: BASELINE TO 6 MONTHS
次要结局
- How effective are chitosan gels on clinical parameters of moderate to severe periodontitis ?
研究者
Jammula Surya Prasanna
Panineeya Mahavidyala Institute of Dental Sciences and Research Centre