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临床试验/NCT02831374
NCT02831374已完成早期 1 期

Assessment Effectiveness of Platelet Rich Plasma in Wound Healing After Surgical Removal of Mandibular Third Molars: A Clinical Study

Linyi People's Hospital0 个研究点目标入组 40 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
40
主要终点
Assessment of pain

研究概览

简要总结

Purpose: This prospective randomized comparative clinical study was conducted to assess the effect of platelet-rich plasma (PRP) gel on soft tissue healing and bone regeneration potential on lower third molar extraction sockets.

Methods: For the study, 50 Patients (37 male, 13 female) requiring surgical removal of a lower impacted third molar and who fulfilled the inclusion criteria were recruited. The patients were categorized into two groups, Group A and Group B. For each group 25 patients were randomly allocated. The predictor variable in Group A was the application of PRP Gel whereas in Group B had no PRP. Postoperative pain, swelling, trismus, soft tissue healing and osseous regeneration was assessed using standard methods. These outcome variables were assessed on 1, 3-, 5-, 7-, and 14-postoperative day. Patients were recalled at the 4th, 10th, and 16th postoperative week for assessment of bone healing. The data were recorded and tabulated.

详细描述

The study is designed as a prospective randomized comparative clinical study. The sample population was composed of fifty consecutive patients who needed surgical extraction of lower third molar under local anesthesia. The study included 37 male and 13 female with age ranging from 20 to 40 years. All Patients were categorized into GROUP A (wound in which PRP is placed) and GROUP B (socket without PRP). The patients were allocated randomly to each group equally by single-blind technique, irrespective of age and sex.

Ethical approval was obtained from the Institutional Ethics Committee prior to the beginning of the study. The signed consent form obtained from all the patients after explaining the risks and benefits of the surgical procedure. The group A (test group) received topical application of PRP, whereas the group B (control group) was left to heal without PRP.

Clinical assessment:

Postoperative pain was assessed using a 10-point visual analog scale (VAS) with a score of 0 equals "no pain" and 10 equals "very severe pain" Facial swelling was assessed by modification of Schultze-Mosgau et al method, and this involved measuring the length from the tragus to the oral commissure and tragus to the pogonion. The arithmetic sum of the two measurements was considered as facial swelling at the time point. The maximum distance between the maxillary central incisors and the mandibular central incisors was taken as mouth opening. The difference between postoperative and preoperative mouth opening value was considered as trismus. Assessment of soft tissue healing was based on the criteria given by Landry et al. and Gonshor et al. Third molar sockets were assessed radiographically for bone healing by modification of Kelley's method as described by Olufemi et al. The percentage of facial swelling and mouth opening was estimated using the method described by Ogundipe et al.

Protocol for preparation of PRP gel Under all aseptic conditions, PRP was processed by means of a modification of the method of Sonnleitner et al. Before surgery, 10 mL of venous blood was collected from the antecubital fossa of the patient's forearm and stored into sterile tubes containing anticoagulant (0.5 mL citrate phosphate dextrose) from each patient of group A in the experimental group using routine venipuncture procedure. The tube was thoroughly agitated to ensure mixing of anticoagulant with the venous blood. The whole blood is then centrifuged at 1,200 rpm for ten minutes. The supernatant layer obtained was platelet poor plasma (PPP) and Buffy coat (BC) and RBCs (red blood cells) at the bottom part. PPP, BC and upper 1-2 mm of RBC (red blood cell) layer was collected in a new sterile tube and centrifuged again at 1,000 rpm for 10 min. The upper half of the supernatant is removed and the lower half is mixed carefully to get PRP. The platelet concentration of the PRP was noted.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age between 18 and 50 years.
  • Patients who required mandibular 3rd molar extractions
  • Patients had to have clinical and radiographic diagnosis of a single impacted mandibular third molar
  • Radiographic diagnosis of Class II position B impaction (Pell and Gregory classification).
  • Patients agree to return for recall visits
  • Patients who were not experienced pain, inflammation, and infection at the operating site 7 days before the surgery.

排除标准

  • Exclusion criterion
  • Patients if pregnant, lactating, or smokers or if they had systemic disease or any other medications that could interfere with healing process.
  • Any antibiotic or any anti-inflammatory drug usage within a week period.
  • Patients with any periapical infection or lesion associated with the third molars
  • Patients with unacceptable oral hygiene

研究组 & 干预措施

Use of platelet rich plasma (Group A)'

Experimental

Local anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Postoperative medication

干预措施: Local anesthesia (Drug)

Use of platelet rich plasma (Group A)'

Experimental

Local anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Postoperative medication

干预措施: surgical extraction of impacted third molar (Procedure)

Use of platelet rich plasma (Group A)'

Experimental

Local anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Postoperative medication

干预措施: Preparation of PRP gel (Biological)

Use of platelet rich plasma (Group A)'

Experimental

Local anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Postoperative medication

干预措施: Placing platelet Rich plasma and suturing (Procedure)

Use of platelet rich plasma (Group A)'

Experimental

Local anesthesia, surgical extraction of impacted third molar, Preparation of PRP gel, Placing platelet Rich plasma and suturing, Postoperative medication

干预措施: Postoperative medication (Drug)

surgical extraction (Group B)

Placebo Comparator

Local anesthesia, surgical extraction of impacted third molar, Suturing, Postoperative medication

干预措施: Local anesthesia (Drug)

surgical extraction (Group B)

Placebo Comparator

Local anesthesia, surgical extraction of impacted third molar, Suturing, Postoperative medication

干预措施: surgical extraction of impacted third molar (Procedure)

surgical extraction (Group B)

Placebo Comparator

Local anesthesia, surgical extraction of impacted third molar, Suturing, Postoperative medication

干预措施: Suturing (Procedure)

surgical extraction (Group B)

Placebo Comparator

Local anesthesia, surgical extraction of impacted third molar, Suturing, Postoperative medication

干预措施: Postoperative medication (Drug)

结局指标

主要结局

Assessment of pain

时间窗: 1 week

Postoperative pain was assessed using a 10-point visual analog scale with a score of 0 equals "no pain" and 10 equals "very severe pain"

Assessment of trismus

时间窗: 1 week

The maximum distance between the maxillary central incisors and the mandibular central incisors was taken as mouth opening. The difference between postoperative and preoperative mouth opening value was considered as trismus.

Assessment of facial swelling

时间窗: 1 week

Facial swelling was assessed by modification of Schultze-Mosgau et al. method, and this involved measuring the length from the tragus to the oral commissure and tragus to the pogonion. The arithmetic sum of the two measurements was considered as facial swelling at the time point.

Assessment of soft tissue healing

时间窗: 1 week

Assessment of soft tissue healing was based on the criteria given by Landry et al. and Gonshor.

Assessment of bone healing

时间窗: 1 week

Third molar sockets were assessed radiographically for bone healing by modification of the Kelley's method as described by Olufemi et al.

次要结局

未报告次要终点

研究者

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

Xiao-Ming Shi

Dr

Linyi People's Hospital

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