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临床试验/CTRI/2024/06/069606
CTRI/2024/06/069606招募中3 期

Comparative evaluation of amniotic membrane and platelet rich fibrin membrane on osseous healing post direct maxillary sinus lift augmented with graft around dental implants A randomised controlled study

King George Medical University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
28
试验地点
1
主要终点
to compare osseous healing around dental implants in both the groups

研究概览

简要总结

It is difficult to restore an edentulous posterior maxilla with dental implants due to poor bone equality & limited available bone length, and sinus floor augmentation may be a crucial surgical operation for bone augmentation in this area prior to implant placement. Implant insertion in an atrophic maxilla may be hampered by inadequate alveolar ridge breadth and bone height. The posterior maxilla implant rehabilitation may be more difficult due to ridge resorption, maxillary sinus pneumatization, and low bone quality.

A reliable and efficient medical procedure is sinus floor augmentation.There have been a number of procedures proposed for the vertical augmentation of the maxillary sinus, with the conventional lateral osteotomy—introduced by Tatum in 1976—remaining the most popular. It is possible to complete the lateral augmentation surgery in one or two phases. The two-stage method refers to placing dental implants after bone healing, whereas the one-stage procedure refers to placing dental implants concurrently with sinus floor augmentation.

In the lateral sinus floor augmentation surgery, there are some variations in the graft materials used for bone augmentation and the timing of implant insertion (simultaneous or delayed).

Autogenous bone from the iliac crest or maxillary tuberosity, frozen bone, freeze-dried bone, xenogeneic bone, demineralized freeze-dried bone, and hydroxyapatite have all been studied for use in maxillary sinus grafts to speed up the bone healing process and prevent repneumonization of the maxillary sinus after grafting. Recent research on sinus transplants has revealed that the type of bone-graft material utilised can have a different impact on long-term outcomes.

Human amniotic membrane (hAM), one of these biologically/naturally generated tissues, has been used in medicine since Dr. Nicholas Sabella first described a clinical case of burns treated by hAM in 1900.It has been documented to have an anti‐ inflammatory, antimicrobial, anti‐tumorigenic nature and analgesic action on local application. The components of hAM, collagen, laminin, fibronectin, and elastin, make them ideal for creating a strong framework for tissue engineering. hAM is biologically active compared to other membranes because it releases growth factors that promote cell migration and promote repair. It can be used with different scaffolds and grafts, such as PRF and hydroxyapatite bone graft, or utilised as an occluding membrane in guided tissue regeneration (GTR). To the best of our knowledge, there have been no studies examining hAM’s impact on the maxillary sinus lift surgery with bovine bone graft in comparison to platelet-rich fibrin. Therefore, the purpose of the current study is to evaluate and compare the impact of hAM and Platelet-rich fibrin membrane on Osseous healing and Angiogenesis when combined with a xenograft around dental implants.

Aim of the study is to compare the effect of amniotic membrane versus platelet rich fibrin membrane on osseous healing post direct sinus lift augmented with graft 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 70.00 Year(s)(—)
性别
All

入选标准

  • Healthy adult patients free from any compromising systemic diseases.
  • Patients need implant insertion in maxillary premolar/molar area.
  • Severely resorbed maxillae having less than 5mm in height and more than 7mm in width of residual alveolar bone.
  • Adequate inter occlusal space that could accommodate the implant abutment and the future restoration.

排除标准

  • Uncontrolled systemic diseases which retard bone healing.
  • Patients who are under bisphosphonates.
  • Presence of any pathology in site of operation.
  • History of maxillary sinusitis or sinus surgery.
  • Heavy smokers 6.

结局指标

主要结局

to compare osseous healing around dental implants in both the groups

时间窗: 1 week, 1 month, 6 months

次要结局

  • Absolute and percentage change in area(Change in Peak Systolic Velocity)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sonali Kaundal

King George Medical University, Lucknow, Uttar Pradesh

研究点 (1)

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