Evaluation of the Effect of Leucocyte Platelet-Rich Fibrin (L-PRF) Technique Applied in Post-extraction Sockets Before Placement of Dental Implants
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
- 是
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
In these post-extraction sockets no intervention takes place.
Group 2: Allograft and collagen membrane
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
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
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
Maria Pavli
BDS(Hons), MSc, PhD candidate, Oral and Maxillofacial University Clinic, Athens Dental School
National and Kapodistrian University of Athens
