NCT06567548 Clinical Comparison of Alb-PRF vs PRF on Postoperative Morbidity Following FGG Harvesting
| NCT ID | NCT06567548 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Palate; Wound |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2025-11-27 |
| Primary Completion | 2026-12-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients in need of free gingival graft 2. Medically free patients 3. Adult patients above 18 years old. 4. Patients accepting a 1-month follow-up period (cooperative patients). 5. Patients who will provide an informed consent. Exclusion Criteria: 1. Smokers 2. Pregnant and lactating women 3. Patients with poor oral hygiene 4. Patients who had previous periodontal surgery in the area of interest