Effect of Concentrated Growth Factor (CGF) on Short Term Clinical Outcomes After Partially Impacted Mandibular Third Molar Surgery: A Split-Mouth Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- soft tissue healing
研究概览
简要总结
The aim of this study was to evaluate the effectiveness of concentrated growth factor (CGF) on soft tissue healing and postoperative side effects following third molar surgery. This study was designed on 60 patients as a randomized single-blind clinical trial. The predictor variable was the implementation of CGF fibrin matrix, which was categorized as CGF and non-CGF. The primary outcome variable of the study was the healing of soft tissue around the extraction socket. The secondary outcome variables were pain, swelling and trismus. Data were analyzed using the non-parametric Brunner and Langer model. Statistical significance was set at P < .001.
详细描述
The study population was composed of subjects presenting to the Department of Oral Surgery for evaluation and management of bilateral, partially-impacted mandibular third molars. The protocol for this study was approved by the local ethics committee and all participants signed an informed consent.
A patient who was referred for extraction of mandibular third molars was examined clinically and radiologically according to the inclusion criteria.
Before the partially-impacted mandibular third molar surgery, randomisation was achieved by use of sealed envelopes, selected by the patient. The envelopes contained cards labelled 'right' or 'left', which indicated the surgical side to receive CGF application.The envelopes were opened by the surgeon after the patients made their selection.
Both partially-impacted mandibular third molars were extracted by the same experienced surgeon. For each patient, the sites operated on were randomly divided into two study groups.
Group I (test); in which CGF fibrin matrix was applied to the extraction socket Group II (control); in which CGF was not applied to the extraction socket Each patient was listed for two surgical appointments. The second extraction was done on the control side, three weeks after the first extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •1- Bilateral, vertically, partially-impacted Class I, Level B third molars
排除标准
- •Infection of the surgical region
- •Smoking habit
- •Alcohol usage
- •Physical or mental disability
- •Thrombocytopenia
- •Chemotherapy in head and neck region
- •Pregnant woman or woman in menstrual cycle
结局指标
主要结局
soft tissue healing
时间窗: Change of soft tissue healing at 7 days
This was assessed on the third and seventh preoperative days using the healing index classified by Landry et al.12. It depends on tissue colour, presence of bleeding on palpation, epithelization of wound margins, granulation tissue and suppuration, and rates the degree of healing attained from 'very poor' to 'excellent'.
次要结局
- presence of trismus(Change of trismus at 7 days)
- presence of swelling(Change of swelling at 7 days)
- severity of postoperative pain(Change of postoperative pain at 7 days)