Clinical Comparison of Albumin Platelet Rich- Fibrin (Alb-PRF) Versus Platelet-rich Fibrin (PRF) on Postoperative Morbidity Following Free Gingival Graft Harvesting: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Postoperative Pain (PP)
研究概览
简要总结
Clinical Comparison of Albumin Platelet Rich- Fibrin (Alb- PRF) versus Platelet-rich fibrin (PRF) on Postoperative Morbidity Following Free Gingival Graft Harvesting: A Randomized Controlled Clinical Trial(RCT)
Study settings:
- The study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University, Egypt.
- Patients will be selected from the Department of Oral Medicine and Periodontology-Cairo University outpatient clinic.
Expected Duration of Participation and Number of Participants: Research Duration: 28 days Number of Participants: 39 volunteers
Work Plan:
During the first visit, preoperative photographs will be taken. Then, participants will be randomly assigned (using a website) into three groups:
Group A: Application of Alb-PRF at the donor site of the free gingival graft. Group B: Application of PRF at the donor site of the free gingival graft. Control: Application of Gelatin Sponge at the donor site.
- 10 ml of venous blood will be drawn from the patient to prepare Alb-PRF and PRF membranes for placement at the donor site.
- The membrane or gelatin sponge will be placed at the donor site and sutured.
Postoperative Protocol:
After surgery, patients will be instructed to take 600 mg of ibuprofen, and 0.12% chlorhexidine gluconate mouthwash for two weeks postoperatively.
Analgesics will be recommended only if there is pain, and no antibiotics will be prescribed.
Patients will receive verbal and written dietary advice postoperatively. They will be encouraged to avoid heat sources and adhere to a diet of cold and soft foods.
Cleaning the adjacent palatal side of the surgical site will be prohibited to avoid irritation, while gentle cleaning will be recommended after dressing removal.
In case of postoperative problems such as unusual bleeding or gum recession, patients will be provided with contact information for their physician for early intervention.
During Visual Analog Scale (VAS) pain recording, patients will be instructed only to describe pain from the palate and to track additional analgesic intake and consumed tablets. Follow-up visits will be scheduled on days 3, 7, 14, 21, and 28 postoperatively.
Postoperative Follow-up:
Palatal sutures will be removed after 7 days post-surgery. On days 14, 21, and 28, wound healing, tissue color match, complete re-epithelialization of the wound, and clinical wound healing area will be monitored.
详细描述
General Operative Procedures: Preoperative Evaluation
- Intra-Oral Examination: Confirm the patient's eligibility based on predefined criteria.
- Phase I Therapy: Perform thorough supragingival scaling and subgingival debridement.
- Plaque Control: Ensure the patient maintains proper mechanical and chemical plaque control.
Clinical Procedure: Free Gingival Graft (FGG) Harvesting
- Preparation: All procedures will be done under sterile conditions and local anesthesia
- FGG Harvesting:
- FGG will be harvested from the palate).
- Make two horizontal incisions (coronal incision 2mm above the gingival margin) and two vertical incisions to outline the graft area.
- Insert a blade along the coronal incision, perpendicular to the bone, then move parallel to the hard palate in a mesiodistal direction to detach the graft while maintaining uniform thickness and avoiding the palatal periosteum.
- Place the graft on sterile saline gauze to prevent shrinkage.
- Control Group:
- Apply an absorbable gelatin sponge to the wound after FGG harvesting.
- Secure with compressive palatal sling sutures ( 5-0 polypropylene).
- PRF Group:
- PRF Preparation: Collect 10 ml of intravenous blood, and centrifuge at 3000 Rounds Per Minute (RPM) for 10 minutes. Extract the PRF clot and form a membrane.
- Apply the PRF membrane over the donor site and secure it with criss-cross sutures ( 5-0 polypropylene).
- Alb-PRF Group:
- Alb-PRF Preparation: Collect 10 ml of intravenous blood, and centrifuge at 700 RPM for 8 minutes. Heat the upper layer to 75°C for 10 minutes to form albumin gel, then cool.
Mix the albumin gel with liquid PRF to form Alb-PRF.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in need of free gingival graft
- •Medically free patients
- •Adult patients above 18 years old.
- •Patients accepting a 1-month follow-up period (cooperative patients).
- •Patients who will provide an informed consent.
排除标准
- •Pregnant and lactating women
- •Patients with poor oral hygiene
- •Patients who had previous periodontal surgery in the area of interest
结局指标
主要结局
Postoperative Pain (PP)
时间窗: VAS will be recorded daily for day 1, 3,7, and 14
The patient will report their pain score directly through VAS score (between 0 and 10; 0: no pain, 1: minimal pain, 5: moderate pain, and 10: severe pain).
次要结局
- Complete wound re-epithelialization (CWE)(day 28)
- Indirect postoperative pain(for 7 days postoperatively)
- Tissue color match (TCM)(will be assessed on day 3, day 7, day 14, day 21, and day 28)
- Delayed wound bleeding (DWB)(day 7)
- Wound clinical healing area(will be assessed on day 3, day 7, day 14, day 21, and day 28)
研究者
Samar Idris Hamelin Idris
Principal Investigator
Cairo University