CTRI/2025/01/079670已完成Phase 3 4
A Comparative Evaluation Of Peri-Implant Healing In Patients Using 0.12% Chlorhexidine And 0.12% Chlorhexidine Plus Hyaluronic Acid Mouthwash By Clinical And Immunological Analysis - An In Vivo Study
未提供1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年2月10日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- "The healing after the use of 0.12% chlorhexidine plus hyaluronic acid mouthwash is expected to demonstrate similar or superior clinical outcomes compared to the use of 0.12% chlorhexidine mouthwash (without hyaluronic acid) in peri-implant tissues."
研究概览
简要总结
- 0.12% Chlorhexidine serves as the standard care, known for its antimicrobial efficacy and long-standing usage in dentistry.
- 0.12% Chlorhexidine + Hyaluronic Acid represents a novel approach, with potential benefits in enhancing tissue healing and reducing inflammation due to HA’s bioactive properties.
Both interventions will allow a comparative analysis of clinical and immunological parameters like IL-1 levels in gingival crevicular fluid (GCF), helping to determine whether the addition of hyaluronic acid provides a significant advantage over chlorhexidine alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Out patients at the hospital within the age group of 18-60 years.
- •Participants who are systemically healthy.
- •Participants requiring dental implant insertion in a single-tooth edentulous area with the presence of healthy teeth adjacent to the healed extracted site Willing and able to provide written informed consent and understand the study protocol.
排除标准
- 未提供
结局指标
主要结局
"The healing after the use of 0.12% chlorhexidine plus hyaluronic acid mouthwash is expected to demonstrate similar or superior clinical outcomes compared to the use of 0.12% chlorhexidine mouthwash (without hyaluronic acid) in peri-implant tissues."
时间窗: base line,6 weeks,12 weeks
次要结局
- "The cytokine (IL1) in GCF/PICF after the use of 0.12% chlorhexidine plus hyaluronic acid mouthwash is expected to reveal reduced levels compared to 0.12% chlorhexidine mouthwash (without hyaluronic acid) in peri-implant tissues."(18 months)
研究者
Dr Shashank Agrawal
Government Dental College
研究点 (1)
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