Clinical Comparison of Alb-PRF vs PRF on Postoperative Morbidity Following FGG Harvesting
NCT Number: NCT06567548
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Palate; Wound
Interventions: OTHER: control group|OTHER: Platelet-rich fibrin (PRF)|OTHER: Albumin Platelet Rich- Fibrin
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-09
Locations: Cairo University, Cairo, 12613, Egypt

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.

Primary Outcome Measures: Postoperative Pain (PP), 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)., VAS will be recorded daily for day 1, 3,7, and 14
Secondary Outcome Measures: Indirect postoperative pain, Will be assessed indirectly by mean consumption of analgesics, for 7 days postoperatively|Tissue color match (TCM), The palatal mucosa's color using Visual analog Scale,VAS Scale (0-10)

Qualitative Ordinal (VAS, will be assessed on day 3, day 7, day 14, day 21, and day 28|Complete wound re-epithelialization (CWE), Complete healing will be assessed using Bubbling test (yes or No) on day 28 and can be confirmed by applying hydrogen peroxide to the wound., day 28|Wound clinical healing area, Measurement of wound closure area using University of North Carolina (UNC-15) periodontal probe to measure the size of palatal wound (width x length) and depth in millimeters., will be assessed on day 3, day 7, day 14, day 21, and day 28|Delayed wound bleeding (DWB), measuring the time of the Measuring the time of the bleeding (Hours, days, weeks), day 7