Effect of Nano crystalline Silver membrane on early wound healing after Implant Placement surgery-A Randomized Clinical study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate and clinically compare early wound healing parameters following
研究概览
简要总结
This study aims to assess the efficacy of a silver nanocrystalline membrane in single stage implant surgery by conducting a randomized controlled trial. 36 patients will be randomly assigned to receive either the silver nanocrystalline membrane with periodontal dressing (Group A) or only periodontal dressing (Group B) or No dressing and No silver nanocrystalline membrane (Group C). Clinical parameters including wound healing, Plaque index, Gingival Index, microbiological analysis, and immunological analysis will be evaluated. Surgical procedures will follow standard protocols, with assessments conducted pre- and post-implantation. Post-operative assessments will include collecting samples for microbiological and immunological analysis and evaluating post-operative early wound healing. The study parameters include clinical monitoring of soft tissue wounds, microbiological parameters comparing total colony counts, and immunological parameters assessing the level of Vascular Endothelial Growth Factor (VEGF) for wound healing. Clinical parameters including wound healing, Plaque index, Gingival Index will be evaluated at 7th,14th and 21st day post implant placement surgery. Microbiological analysis, and immunological analysis will be evaluated at baseline and 7th day post implant placement surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Non-smokers (former smokers were included if they had not smoked within 6 months of the study initiation),2.Presence of edentulous site in mouth that is indicated for implant surgery,3.Patients who give consent,
- •Patients with good general health with no other condition contraindicating routine dental treatment and implant surgery.
排除标准
- •1.Patients chronically treated (i.e., 2 week or more) with any medication that affect periodontal status (i.e., antibiotics or non-steroidal anti-inflammatory drugs), with clinically significant or unstable organic diseases or compromised healing potential (i.e., connective tissue disorders or bone metabolic diseases)
- •Patients on Bisphosphonate therapy, Radiation therapy ,Chemotherapy
- •Patients allergic to Silver
- •Pregnant women or lactating
- •Patients affected by active infectious diseases, immune-compromised, or taking steroid medications
- •Patients who do not give consent.
结局指标
主要结局
To evaluate and clinically compare early wound healing parameters following
时间窗: Healing Index by LANDRY et al, Modified Plaque Index for dental implants ( Mombelli et al,1987) and Modified Gingival Index (Loe,1967) at 7th,14th and 21st day post implant placement
implant placement surgery using a nanocrystalline silver membrane.
时间窗: Healing Index by LANDRY et al, Modified Plaque Index for dental implants ( Mombelli et al,1987) and Modified Gingival Index (Loe,1967) at 7th,14th and 21st day post implant placement
次要结局
- Total Colony Count of microbial flora and Immunological(marker (VEGF) in all the three groups)
研究者
Shreya
Department of Periodontics, Dr Harvansh Singh Judge Institute of Dental Sciences