The Usefulness of Injectable-Platelet Rich Fibrin in the Lower Third Molar Extraction: a Randomized-controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Postoperative swelling
研究概览
简要总结
Lower third molar extraction is one of the most frequently performed surgical procedures in dentistry. Common sequelae, including pain, swelling and trismus, can severely affect patients' quality of life during the immediate postoperative period.
The aim of this randomized-controlled trial is to clinically evaluate the reduction of lower third molar extraction-related complications, such as swelling and pain, and wound healing, following submucosal infiltration of injectable platelet rich fibrin.
详细描述
Forty young patients with a partially or totally impacted lower third molar, with an equivalent degree of difficulty, will be selected. All patients will be randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 20 cases: in the first group, the extraction socket will be left healing spontaneously, while in the other side the socket will be filled with i-PRF.
This study was designed as a double-blind research since the investigator will be unaware of their treatment allocation before surgery, and one clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform clinical measurement of the outcomes on the surgery day, 3th and 7th days after surgery.
A software will be used to produce a random sequence of 20 integer numbers without duplicates generated from atmospheric noise 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 to group 1 or group 2.
Prior to surgery, photographic documentation consisting of frontal extraoral photograph, extraoral latero-lateral photograph of the surgery site, extraoral latero-lateral photograph of the opposite site will be performed.
The swelling will be measured summing two linear measurements of distance between Tragus and Pogonion and then Gonion and Commissura labialis points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator will be unaware of their treatment allocation before surgery. One clinician, not involved in patient treatment and not aware of what therapeutic approach, performed clinical measurement of face swelling on the surgery, 3th and 7th days.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Need for extraction of totally or partially impacted lower third molar
- •Equivalent degree of difficulty of lower third molar extraction
- •Patients able to understand and sign informed consent
排除标准
- •General contra-indications for surgery (systemic disease, compromised immune system etc);
- •Tobacco smoking
- •Alcohol and drug abuse
- •Pregnancy and breastfeeding
- •Patients taking any medications which might interfere with healing
- •Dysplastic processes in the affected tooth elements
- •Non-cooperative patients
- •EXCLUSION CRITERIA DURING FOLLOW-UP - Patients who do not adhere throughout the duration of follow-up to the specialist visits
- •POSTOPERATIVE EXCLUSION CRITERIA
- •- Taking more than two doses of prescribed anti-inflammatory/analgesic medication
结局指标
主要结局
Postoperative swelling
时间窗: Measurements will be taken before surgery, on day 3 and day 7.
Measurements will be made with a flexible ruler taking as reference the diagonals joining Tragus and Pogonion; Gonion and Labial Commissura. Swelling will be calculated as the sum of these diagonals.
次要结局
- Postoperative pain(Everyday after surgery until 7th day.)
研究者
Gilberto Sammartino
Full Professor
University of Naples