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临床试验/CTRI/2024/09/074175
CTRI/2024/09/074175已完成不适用

Comparison of quality of bone formation, insertion torque and implant stability between early implant placement and delayed implant placement in sockets preserved with A-PRF A Randomized control trial

Dr Neelarchana Seelam1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Implant stability quotients (ISQ) between early implant placement and delayed implant placement

研究概览

简要总结

The success of dental implants largely depends on the quality of bone formation, the mechanical stability of the implant at the time of placement, and the long-term stability during the healing process. Bone quality and implant stability are critical determinants of osseointegration. Advanced platelet–rich fibrin (A-PRF) has emerged as a promising biomaterial for enhancing bone healing and regeneration. It contains a high concentration of growth factors and cytokines, which can accelerate tissue healing and bone regeneration. Preservation of extraction sockets using A-PRF aims to maintain the alveolar ridge’s volume and quality. This could solve ongoing debates in implant dentistry on optimal timing for implant placement following tooth extraction.This randomized control trial aimed to compare the quality of bone formation, insertion torque, and implant stability between early implant placement (EIP) at 8 weeks and delayed implant placement (DIP) at 12 weeks in extraction sockets preserved with advanced platelet-rich fibrin (A-PRF).Twenty patients requiring extractions in the maxillary premolar region will be randomized into two groups: EIP (Early Implant Placement - 8 weeks post-extraction) and DIP (Delayed Implant Placement - 12 weeks post- extraction). All the teeth will be extracted atraumatically using piezotomes, and sockets will be preserved using A-PRF. Primary outcomes of the study included histomorphometric analysis of bone, insertion torque values measured at the implant placement, and implant stability quotient (ISQ) measured at placement and after 1 and 3 months.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • •Patient with age 20 – 50 years
  • •American Society of Anaesthesiologists (ASA) -1 category
  • •Bilateral or unilateral with one or more teeth advised for extraction in the maxillary premolar region
  • •Non-restorable carious lesion
  • •Root resorption, root caries and root fracture with questionable prognosis
  • •Intact buccal cortical plate after extraction.

排除标准

  • •Patients subjected to radiotherapy in the head and neck
  • •ASA – II, III, IV, V patients
  • •Patients with poor compliance
  • •Chronic smokers
  • •Medical conditions or medications known to alter soft tissue or bone healing
  • •Active local or systemic infection
  • •Roots extending into the maxillary sinus
  • •Dehiscence in buccal cortical plates after extraction.

结局指标

主要结局

Implant stability quotients (ISQ) between early implant placement and delayed implant placement

时间窗: At Baseline, 1 and 3 months

次要结局

  • Quality of bone formation(Baseline - at the time of implant placement.)
  • Insertion torque(Baseline - at the time of implant placement.)

研究者

发起方
Dr Neelarchana Seelam
申办方类型
Other [self]

研究点 (1)

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