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

NCT06567548 | Recruiting

• 1 other identifier: 17624
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

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.

Conditions

Palate; Wound

Keywords

PRF; Alb-PRF; FGG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Complete wound re-epithelialization (CWE)

  day 28

• Wound clinical healing area

  will be assessed on day 3, day 7, day 14, day 21, and day 28

• Delayed wound bleeding (DWB)

  day 7

Study Arms (3)

Control group

ACTIVE COMPARATOR

absorbable gelatin sponge

Other: control group

Platelet-rich fibrin (PRF) group

ACTIVE COMPARATOR

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.

Other: Platelet-rich fibrin (PRF)

Albumin Platelet Rich- Fibrin (Alb-PRF) group:

EXPERIMENTAL

Albumin Platelet-Rich Fibrin (Alb-PRF) 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.

Other: Albumin Platelet Rich- Fibrin

Interventions

control group OTHER

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

Control group

Platelet-rich fibrin (PRF) OTHER

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.

Platelet-rich fibrin (PRF) group

Albumin Platelet Rich- Fibrin OTHER

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.

Albumin Platelet Rich- Fibrin (Alb-PRF) group:

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Smokers
• Pregnant and lactating women
• Patients with poor oral hygiene
• Patients who had previous periodontal surgery in the area of interest

Sponsors & Collaborators

• Cairo University: lead

Study Sites (3)

Cairo University

Cairo, Cairo Governorate, 12613, Egypt

NOT YET RECRUITING

Cairo University

Cairo, Cairo Governorate, 12613, Egypt

RECRUITING

Cairo University

Giza, Cairo Governorate, 12567, Egypt

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Enji Mahmoud, Phd

  Cairo University

  STUDY DIRECTOR

• Sarah Elbanna, Phd

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Samar Idris Hamadelnil Idris Samar Idris, master

CONTACT

01273600331; samar.Idris@dentistry.cu.edu.eg

samar idris

CONTACT

01553172036; samar.Idris@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 22, 2024
• Study Start: November 27, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

EG (3)