Leukocyte and Platelet-rich Fibrin (L-PRF) Effects on Alveolar Ridge Preservation. A Randomized Controlled Clinical Trial With One Year Follow up
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Radiographic linear changes in horizontal width of the alveolar ridge
研究概览
简要总结
The goal of this clínical trial is to compare in patients needing extraction of anterior teeth the effects of leukocyte-and platelet-rich fibrin (L-PRF) for alveolar ridge preservation versus spontaneous healing. The main questions it aims to answer are:
- Does L-PRF use as alveolar ridge preservation material diminish volumetric changes in the alveolar ridge produced after tooth extraction and further bone regeneration needs?
- Does it have any advantage for wound healing and patient-related outcomes? Participants will undergo
- Tooth extraction
- Alveolar ridge preservation/ spontaneous healing
- Implant placement
Researchers will compare alveolar ridge preservation with L-PRF with spontaneous healing to see if there is an effect on reducing ridge dimensional changes happening after tooth extraction.
详细描述
-Objectives
The main objective is to determine if L-PRF use as alveolar ridge preservation material diminishes volumetric changes in the alveolar ridge produced after tooth extraction and needs of bone regeneration previous or simultaneous to implant placement compared to spontaneous healing.
Secondary objectives:
To determine if there are differences in wound healing after the use of L-PRF compared to spontaneous healing.
To investigate if there are differences in Patient Reported Outcome measures after the use of L-PRF compared to spontaneous healing.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor blinded for treatment groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients ≥18 years old
- •Need for extraction of a tooth in the anterior area (position of second premolar to second premolar in maxilla or mandible) that needs to be replaced by an implant-supported restoration
- •Presence of natural teeth mesially and distally of tooth to be extracted, periodontally healthy (probing depths <5 mm without bleeding on probing).
排除标准
- •Systemic conditions affecting bone or soft tissue healing
- •Smokers of more than 10 cigarettes a day or equivalent to cigarettes
- •Breastfeeding or pregnant women
- •Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent
结局指标
主要结局
Radiographic linear changes in horizontal width of the alveolar ridge
时间窗: From tooth extraction (Baseline) to four months healing (4m)
Cuantitative variable. A validated method to superimpose the radiographs will be used (Ortiz-Vigón et al., 2018; Sanz-Martín et al., 2019).A digital imaging software (SMOP®, Swissmeda Ltd©, Zurich, Switzerland) is used to convert DICOM files into STL files. The images from Baseline and 4 months CBCTs were superimposed using common reference points. After a "fine fit" of the two surfaces, it will appear as a merged contour in axial, coronal, and sagittal views. The center of the alveolus will be determined mesiodistally in the occlusal view. Linear changes in width between 4 months and baseline will be determined by horizontal lines drawn perpendicular to the longitudinal axis in the center of the socket. Three measurements will be taken at 1mm (HRW1), 3mm (HRW3), and 5mm (HRW5) below the Bl bone crest. The change will be calculated by subtraction of the 4 months to Baseline distance in millimeters.
次要结局
- Patient reported outcome measures(At one week, one month and four months visit.)
- Volumetric changes(From tooth extraction (Baseline) to four months healing (4m))
- Percentage of mineralized bone(4 months after tooth extraction, during the implant placement surgery.)
- Changes in ridge contour(From tooth extraction (Baseline) to four months healing (4m))
- Radiographic linear changes height of the alveolar ridge(From tooth extraction (Baseline) to four months healing (4m))
- Bone regeneration needs(4 months after tooth extraction)
研究者
Carolina Encalada Abad, DDS
PhD candidate, Master in Periodontology and Implant dentistry.
Universidad Complutense de Madrid