跳至主要内容
临床试验/NCT07387913
NCT07387913进行中(未招募)不适用

Evaluation of the Effect of Leucocyte Platelet-Rich Fibrin (L-PRF) Technique Applied in Post-extraction Sockets Before Placement of Dental Implants

National and Kapodistrian University of Athens1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Radiographic assessment of the bone specimens

研究概览

简要总结

Aim of study: The application of L-PRF membrane in post-extraction sockets outmatches the use of a) allograft covered with a collagen fleece b) allograft combined with L-PRF membrane c) natural healing, with reference to bone remodeling and regeneration of post-extraction sockets.

Moreover, it will be examined whether the application of L-PRF membrane leads to faster bone maturation and creation of a favorable biological environment for earlier implant placement.

Materials and methods: This study is taking place in Athens University Dental School, in Oral and Maxillofacial Surgery Clinic. All patients participating in the present study received thorough informed consent. All forty patients participating in this study, were subjected in at least one atraumatic and flapless extraction of a single rooted tooth in the maxilla or mandible. Then, the patients were randomly divided in four categories with regards to management of the socket: a) no intervention i.e. Natural healing b) application of L-PRF membrane in the socket c) application of allograft (Phoenix) covered with a collagen fleece d) application of allograft (Phoenix) covered with a L-PRF membrane. Interrupted sutures will be performed for the four extraction socket groups.

Radiographic examination (localized CBCT) was obtained immediately before the extraction, as well as three months post-operatively (localized CBCT) in order to assess the changes in the alveolar ridge dimensions. The next stage of the study refers to the rehabilitation of the edentulous region.

Before each patient was subjected to dental implant placement, a bone biopsy was obtained.

Therefore, all the biopsy specimens obtained went through histological evaluation in order to assess qualitative and quantitative features.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Single-rooted teeth needed to be extracted in the maxilla or mandible
  • Patient in good general health as documented by self-assessment
  • Patients must be committed to the study and sign the informed consent
  • Adults only as participants

排除标准

  • No systemic medical condition that could interfere with the surgical procedure or planned treatment.
  • Smokers >20 cig/day
  • Current pregnancy or breast feeding
  • Radiotherapy or chemotherapy in head and neck area intravenous and oral bisphosphonates or anti-angiogenic drugs

研究组 & 干预措施

Group 1: Control

No Intervention

In these post-extraction sockets no intervention takes place.

Group 2: Allograft and collagen membrane

Experimental

In order to perform alveolar ridge preservation in this group allograft and collagen membrane are placed in the post-extraction sockets.

干预措施: Allograft and collagen membrane (Procedure)

Group 3: Allograft and L-PRF membrane

Experimental

In order to perform alveolar ridge preservation in this group allograft and L-PRF membrane are placed in the post-extraction sockets.

干预措施: Allograft and L-PRF membrane (Procedure)

Group 4: L-PRF membrane

Experimental

In order to perform alveolar ridge preservation in this group L-PRF membrane is placed in post-extraction sockets.

干预措施: L-PRF (Procedure)

结局指标

主要结局

Radiographic assessment of the bone specimens

时间窗: 3 months

Comparison of quantitative clinical alveolar ridge dimensions (in mm) between the four groups will be performed, 3 months after alveolar ridge preservation. Radiographic evaluation will take place and changes in horizontal dimension will be measured. The horizontal bone width of the ridge at the time of the extraction and after 3 months during the implant placement procedure will be measured in mm.

次要结局

  • Radiographic assessment of the bone specimens(3 months)
  • Histological assessment of the bone harvested from the post-extraction sockets(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Pavli

BDS(Hons), MSc, PhD candidate, Oral and Maxillofacial University Clinic, Athens Dental School

National and Kapodistrian University of Athens

研究点 (1)

Loading locations...

相似试验