跳至主要内容
临床试验/CTRI/2024/11/076348
CTRI/2024/11/076348尚未招募3 期

Evaluation and comparison of the efficacy of autologous fibrin glue with 4-0 resorbable mono filament sutures following implant placement-a randomized clinical trial

Dr Ankita Priya1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
1. Wound Healing Index

研究概览

简要总结

Traditional sutures in dentistry, while commonly used for intraoral wound closure, have several drawbacks, including tissue trauma, food debris accumulation, and potential for stitch abscess due to improper removal. These issues, coupled with patient discomfort, have driven the need for alternative closure methods. Tissue adhesives, such as fibrin sealants, cyanoacrylates, and collagen-based compounds, have emerged as viable options. These adhesives create a strong bond between wound edges, preventing separation, and are easier to apply. However, some tissue adhesives, like cyanoacrylates, have toxic degradation products that pose risks, making them less favorable. Fibrin glue, introduced in the 1940s, is commonly used but has limitations, including the risk of allergic reactions and viral transmission from its bovine-derived components. Commercial fibrin glue is also expensive. Autologous fibrin glue (AFG), derived from the patient’s own blood, addresses these issues by reducing the risk of infection, promoting faster healing, and being cost-effective. AFG also supports cell growth, differentiation, and acts as a scaffold for bone regeneration, making it a promising alternative to sutures. The study aims to evaluate and compare the efficacy of autologous fibrin glue with 4-0 resorbable monofilament sutures after implant placement. The study, conducted at the Department of Periodontology and Oral Implantology, I.T.S. Centre for Dental Studies and Research, will be a randomized clinical trial comparing autologous fibrin glue (AFG) and 4-0 resorbable monofilament sutures for wound closure following implant placement. A total of 24 edentulous sites will be randomly assigned to either AFG (Group 1) or sutures (Group 2). Participants, aged 18-65, with adequate oral hygiene and sufficient bone volume, will be included, while those with systemic diseases, poor oral hygiene, or other contraindications will be excluded. Clinical parameters, such as flap stability, wound healing indices, and pain perception, will be assessed along with radiographic evaluations of crestal bone levels. Histological analysis of wound healing characteristics will also be performed. Before surgery, patients will undergo scaling, root planing, and CBCT scans, followed by implant placement with either AFG or sutures. AFG will be prepared from the patient’s own blood using a modified method involving centrifugation and mixing with calcium chloride. The study aims to assess the efficacy of AFG in improving wound healing and tissue adaptation around dental implants.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with adequate oral hygiene status.
  • 2.No active periodontal disease present.
  • 3.Patients requiring the replacement of one or more non-restorable teeth with sufficient bone volume will be selected for the study.
  • 4.Patients willing to provide informed consent and maintain adequate oral hygiene.
  • 5.Patients with good compliance to attend follow-ups.

排除标准

  • 1.Patients with uncontrolled systemic diseases that might preclude the use of dental implants.
  • 2.Patients with autoimmune diseases or psychiatric disorders.
  • 3.Patients undergoing or who have undergone radiation therapy and chemotherapy to the head and neck region within the last 12 months.
  • 4.Patients with poor oral hygiene.
  • 5.Alcoholics, drug abusers, or heavy smokers.
  • 6.Pregnant or lactating women.
  • 7.Insufficient bone volume or damage to the cortical plate after extraction.
  • 8.Patients who are unable to provide informed consent at the time of the procedure.

结局指标

主要结局

1. Wound Healing Index

时间窗: Wound healing index- 1,7,30 days | histological characteristics of wound healing- 90 days | Crestal bone levels- day 0 and 90 days

2. Histological characteristics of wound Healing

时间窗: Wound healing index- 1,7,30 days | histological characteristics of wound healing- 90 days | Crestal bone levels- day 0 and 90 days

3. Crestal bone levels

时间窗: Wound healing index- 1,7,30 days | histological characteristics of wound healing- 90 days | Crestal bone levels- day 0 and 90 days

次要结局

  • 1. wound healing characterstics by punch biopsy(2. crestal bone levels)

研究者

发起方
Dr Ankita Priya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ankita Priya

I.T.S Dental College ,Ghaziabad

研究点 (1)

Loading locations...

相似试验