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

March 23, 2026 updated by: Samar Idris Hamelin Idris, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 12613
        • Not yet recruiting
        • Cairo University
      • Cairo, Cairo Governorate, Egypt, 12613
        • Recruiting
        • Cairo University
      • Giza, Cairo Governorate, Egypt, 12567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
absorbable gelatin sponge
Other: control 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
Active Comparator: Platelet-rich fibrin (PRF) group
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)
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.
Experimental: Albumin Platelet Rich- Fibrin (Alb-PRF) group:
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain (PP)
Time Frame: 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).
VAS will be recorded daily for day 1, 3,7, and 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indirect postoperative pain
Time Frame: for 7 days postoperatively
Will be assessed indirectly by mean consumption of analgesics
for 7 days postoperatively
Tissue color match (TCM)
Time Frame: will be assessed on day 3, day 7, day 14, day 21, and day 28

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)
Time Frame: day 28
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
Time Frame: will be assessed on day 3, day 7, day 14, day 21, and day 28
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)
Time Frame: day 7
measuring the time of the Measuring the time of the bleeding (Hours, days, weeks)
day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Enji Mahmoud, Phd, Cairo University
  • Study Director: Sarah Elbanna, Phd, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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