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临床试验/NCT04131894
NCT04131894已完成4 期

Healing of Extraction Sockets Preserved With Autogenous Dentin Graft: A Clinical, Histological, Histomorphometrical and Electron Microscobic Study

Bahçeşehir University0 个研究点目标入组 9 人开始时间: 2016年12月5日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
9
主要终点
Immunohistochemical Evaluation

研究概览

简要总结

Various graft materials are used to reconstruct bone defects in the jaws due to tooth loss, trauma, advanced periodontal diseases, pathological lesions and congenital disorders. The main features of an ideal bone graft are osteogenesis, osteoinduction and osteoconduction. Autogenous bone graft is considered as the gold standard among all bone graft materials. Because it has all the features that an ideal bone graft should have. However, there are some disadvantages such as donor site morbidity, obtaining limited amounts and high rates of resorption. Because of these disadvantages, other bone graft materials such as allografts, xenografts and alloplastic bone grafts are frequently used for bone augmentation. In the light of recent studies, the limits of conventional bone graft materials such as limited osteoconduction capacity and disease transmission have been clearly demonstrated. Due to the disadvantages of these materials, studies are directed to develop alternative graft materials. Aim of this study is to analyse the effects of autogenous dentin graft and mixture of autogenous dentin graft and platelet rich fibrin (PRF) applied to the tooth extraction sockets on bone healing process. A total of 57 extraction sockets in 9 patients who were planned to be treated with dental implant after tooth extraction were evaluated in this study. Extraction sockets were divided randomly into 3 groups. In the first group, sockets were filled with autogenous dentin graft (Group D-20 sockets). In the second group, sockets were filled with the mixture of PRF and autogenous dentin graft (Group DP-21 sockets). In the third group, sockets were left empty as control group (Group C-16 sockets). After 3 months, histological and immunohistochemical evaluations were performed on the samples taken during the implant surgery. Additionally, samples obtained from each group were examined by scanning electron microscopy (SEM).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age≥18 years,
  • Systemically healthy patients (ASA I and II),
  • Adequate restorative space for implant-retained restoration.

排除标准

  • Teeth with deep decay or root canal filling,
  • Systemically complicated patients (ASA III, IV, V),
  • Presence of acute infection,
  • Pregnancy or lactation,
  • Unwillingness to return for the follow-up periods

研究组 & 干预措施

Control

No Intervention

Extraction sockets with spontaneous healing (16 sockets).

Dentin

Active Comparator

Extraction sockets were filled with undemineralized autogenous dentin graft (20 sockets).

干预措施: autogenous dentin graft (Biological)

Dentin+PRF

Active Comparator

Extraction sockets were filled with mixture of undemineralized autogenous dentin graft and platelet rich fibrin (PRF) (21 sockets).

干预措施: platelet rich fibrin (PRF) (Biological)

Dentin+PRF

Active Comparator

Extraction sockets were filled with mixture of undemineralized autogenous dentin graft and platelet rich fibrin (PRF) (21 sockets).

干预措施: autogenous dentin graft (Biological)

结局指标

主要结局

Immunohistochemical Evaluation

时间窗: 3 months after the augmentation procedure

Sections (5 µm) were taken from each sample and deparafinization was completed. Mouse and Rabbit Specific HRP / AEC (ABC) Detection IHC Kit (Abcam, USA) was used to perform the reactions. After this process, the sections were exposed until color change in order to show the immune reaction in the tissue and counterstained briefly with Mayer's hematoxylin. Anti-BMP-2 and anti-RUNX-2 antibodies (Abcam, USA) were used. Finally, the sections were washed with distilled water and then covered with immune closure medium. Images were taken in X4, X10, X20 magnification using light microscope (Olympus BX43, Center Valley, PA) with camera attachment (Carl Zeiss, Germany).

Scanning Electron Microscopy (SEM) Evaluation

时间窗: 3 months after the augmentation procedure

After the drying process, 4 samples from each group were coated with a 10 nm thick gold-palladium layer using the coating device (Balzers-SCd 050, Germany). The samples were analyzed at 10 kV with the SEM device (JSM-7001 F, JEOL, Tokyo, Japan) for the purpose of examining the surface formation. For each group, the image was taken at X2000, X5000 and X10.000 magnification.

Histopathological Evaluation

时间窗: 3 months after the augmentation procedure

Samples obtained from the groups were fixed in 10% formalin solution and decalcified in 5% formic acid solution. The samples were gradually dehydrated in an ethanol series, placed in xylene for clearing, and then embedded in paraffin. The tissue blocks were sectioned at 5µm on a rotary microtome (Leica RM 2125RT, Nussloch, Germany). Sections were stored overnight at 60°C for deparaffinization. Then the deparaffinization process was completed with xylene series. Following this procedure, the sections were passed from the alcohol series and dehydrated. Following deparaffinization, all sections were stained using Hematoxylin-Eosin staining method. Five sections were taken from each sample and used for histopathological evaluation. Images were taken from all sections in X4, X10 and X20 magnification using light microscope (Olympus BX43, Center Valley, PA) with camera attachment. New bone, connective tissue, graft and blood vessel volumes were evaluated by histopathological scoring method.

次要结局

未报告次要终点

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezgi Yüceer Çetiner

Assistant Professor

Bahçeşehir University

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