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Clinical Comparison of Alb-PRF vs PRF on Postoperative Morbidity Following FGG Harvesting

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06567548
Enrollment
39
Registered
2024-08-22
Start date
2025-11-27
Completion date
2027-01-30
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palate; Wound

Keywords

PRF, Alb-PRF, FGG

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.

Detailed description

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. * Apply the Alb-PRF membrane over the donor site and secure it with criss-cross sutures ( 5-0 polypropylene). Postsurgical Care * Pain Management: Take Ibuprofen 600 mg as needed. * Mouthwash: Use 0.12% chlorhexidine gluconate for two weeks. * Dietary Instructions: Follow a cold, soft diet; avoid hot foods. * Oral Hygiene: Avoid brushing near the surgical site; gentle brushing is allowed after pack removal. * Emergency Contact: Provided for issues like abnormal bleeding. * Pain Assessment: Use the Visual Analog Scale (VAS) to assess pain in the palate. * Follow-Up: Scheduled for 3, 7, 14, 21, and 28 days post-surgery. * Suture Removal: 7 days after surgery.

Interventions

OTHERcontrol group

An absorbable gelatin sponge is a sterile hemostatic agent primarily composed of purified porcine-derived gelatin. It is widely utilized in surgical procedures to control bleeding

Platelet-rich fibrin (PRF) is a biomaterial derived from the patient's own blood, utilized primarily in regenerative medicine and surgery due to its rich content of growth factors and its ability to promote healing.

OTHERAlbumin Platelet Rich- Fibrin

is an innovative biomaterial that combines the regenerative properties of platelet-rich fibrin (PRF) with the structural and functional benefits of albumin. This mixture is designed to enhance tissue healing and regeneration by utilizing autologous blood components.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain (PP)VAS will be recorded daily for day 1, 3,7, and 14The 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).

Secondary

MeasureTime frameDescription
Indirect postoperative painfor 7 days postoperativelyWill be assessed indirectly by mean consumption of analgesics
Tissue color match (TCM)will be assessed on day 3, day 7, day 14, day 21, and day 28The palatal mucosa's color using Visual analog Scale,VAS Scale (0-10) Qualitative Ordinal (VAS
Complete wound re-epithelialization (CWE)day 28Complete healing will be assessed using Bubbling test (yes or No) on day 28 and can be confirmed by applying hydrogen peroxide to the wound.
Wound clinical healing areawill be assessed on day 3, day 7, day 14, day 21, and day 28Measurement 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.
Delayed wound bleeding (DWB)day 7measuring the time of the Measuring the time of the bleeding (Hours, days, weeks)

Countries

Egypt

Contacts

CONTACTSamar Idris Hamadelnil Idris Samar Idris, master
samar.Idris@dentistry.cu.edu.eg01273600331
CONTACTsamar idris
samar.Idris@dentistry.cu.edu.eg01553172036
STUDY_DIRECTOREnji Mahmoud, Phd

Cairo University

STUDY_DIRECTORSarah Elbanna, Phd

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026