The Use of Platelet-Rich Fibrin as Solely Filling Material in Socket Preservation Technique: a Randomized-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Periodontal probe - alveolar crest distance
研究概览
简要总结
The loss of a tooth or change in its function is lead to a change in alveolar ridge's height and volume. Socket preservation (SP) is a procedure designed to prevent or limit alteration of the post-extraction bone ridge to achieve an optimal prosthetic implant rehabilitation. The aim of this randomized-controlled clinical trial is to suggest that platelet rich fibrin (PRF) as solely grafting material may be a valid tool in this technique.
详细描述
80 patients with mandibular or maxillary premolars that need to be extracted will be recruited. All patients will be randomly treated by using two different therapeutic approaches, thereby yielding two different study groups, each of which is composed of 40 cases: in the test group the socket preservation technique with PRF will be performed, in control group the post-extraction socket is left healing spontaneously without performing socket preservation.
A software will be used to produce a random sequence of 80 integer numbers without duplicates generated by a software and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated either to test or control group. All patients are informed by the written consent obtained that they could be causally allocated to one of the two groups.
Before extraction, patients should undergo to periodontal treatment and instrumental investigations such as orthopantomography.
After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the bone cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and the granulation tissue are removed.
In the test group, a blood collection of 40 ml will be performed and PRF is made according to the manufacturer instructions.
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 (Investigator, Outcomes Assessor)
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
- •Mandibular or maxillary premolars that need to be extracted due to endodontic failure, caries or fractures and will need to be replaced with a dental implant after 3 months of healing
- •Full mouth plaque score ≤ 25% at onset
- •Full mouth bleeding score ≤ 25% at onset
- •Integrity of the alveolar walls after extraction
- •Vestibular wall thickness < 1 mm
- •Patients able to understand and sign informed consensus
排除标准
- •Significant medical conditions contraindicating surgery
- •Pregnancy and breastfeeding
- •Tobacco smoking (>15 cigarettes per day)
- •Immunocompromised patients
- •Alcohol and drug abuse
- •Uncooperative patients
- •Periodontally compromised patients
- •Acute abscesses at the extraction site
- •Other dental elements that are not premolars
- •Patients who do not show up for scheduled checkups
结局指标
主要结局
Periodontal probe - alveolar crest distance
时间窗: Immediately after surgery, 3 months after surgery
Vertical distance measured with a periodontal probe from the alveolar crest (AC) to a reference periodontal probe (P) connecting the cement-enamel junction (CEJ) of the teeth adjacent.
Width
时间窗: Immediately after surgery, 3 months after surgery
Horizontal alveolar ridge thickness from the external face of the buccal wall to the outer face of the lingual side is measured with a hand caliper, 1 mm apically from the alveolar ridge in the central area.
Vestibular bone wall thickness
时间窗: Immediately after surgery, 3 months after surgery
It is measured with a hand caliper at the center of the vestibular wall, 1 mm apically from the ridge.
次要结局
- Wound healing index(3, 7, 14, 28 days after surgery)
研究者
Gilberto Sammartino
Full professor
University of Naples