Palate; WoundNCT06567548
Clinical Comparison of Alb-PRF vs PRF on Postoperative Morbidity Following FGG Harvesting
A study testing Platelet-rich fibrin (PRF) and Albumin Platelet Rich- Fibrin in people with Palate; Wound, run by Cairo University at 3 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Palate; Wound
- What is being tested?
- Platelet-rich fibrin (PRF) and Albumin Platelet Rich- Fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesEgypt
- Study dates
- 27 Nov 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Smokers
- Pregnant and lactating women
- Patients with poor oral hygiene
- Patients who had previous periodontal surgery in the area of interest
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites, 3 recruiting
- Not yet recruiting
Cairo University
Cairo, Cairo Governorate, 12613
- Recruiting
Cairo University
Cairo, Cairo Governorate, 12613
- Recruiting
Cairo University
Giza, Cairo Governorate, 12567
Idris, 127300331, samar.Idris@dentistry.cu.edu.eg
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Palate; Wound
- Being tested
- control group, Platelet-rich fibrin (PRF), Albumin Platelet Rich- Fibrin
- Keywords
- PRF, Alb-PRF, FGG
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
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)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.
Albumin Platelet Rich- FibrinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | absorbable gelatin sponge Receives: 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. Receives: 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. Receives: Other: Albumin Platelet Rich- Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: VAS will be recorded daily for day 1, 3,7, and 14
Secondary outcomes (5)
Indirect postoperative pain
Will be assessed indirectly by mean consumption of analgesics
Measured: for 7 days postoperatively
Tissue color match (TCM)
The palatal mucosa's color using Visual analog Scale,VAS Scale (0-10)
Qualitative Ordinal (VAS
Measured: 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.
Measured: 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.
Measured: 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)
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start27 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palate; WoundStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Idris Hamelin Idris, Cairo University
- Investigators
- Enji Mahmoud, Phd, Study director, Cairo UniversitySarah Elbanna, Phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567548
- Sponsor's protocol ID
- 17624
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06567548
- Acronym / sponsor ID
- 17624
- Conditions
- Palate; Wound
- Keywords
- PRF, Alb-PRF, FGG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: control groupabsorbable gelatin sponge |
| Platelet-rich fibrin (PRF) group | Active comparator | 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. |
| Albumin Platelet Rich- Fibrin (Alb-PRF) group: | Experimental | Other: Albumin Platelet Rich- FibrinAlbumin 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Smokers
- Pregnant and lactating women
- Patients with poor oral hygiene
- Patients who had previous periodontal surgery in the area of interest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control groupAn 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 | Other | Control group |
| 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. | Other | Platelet-rich fibrin (PRF) group |
| Albumin Platelet Rich- Fibrinis 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 (Alb-PRF) group: |
Primary outcome
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).
5 secondary outcomes
Indirect postoperative pain
Time frame: 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
Complete wound re-epithelialization (CWE)
Time frame: day 28
Wound clinical healing area
Time frame: will be assessed on day 3, day 7, day 14, day 21, and day 28
Delayed wound bleeding (DWB)
Time frame: day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enji Mahmoud, Phd study director
Cairo University
Sarah Elbanna, Phd study director
Cairo University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich fibrin (PRF) and Albumin Platelet Rich- Fibrin in people with Palate; Wound, run by Cairo University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Idris Hamadelnil Idris Samar Idris, master (01273600331, samar.Idris@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (PP) (time frame: VAS will be recorded daily for day 1, 3,7, and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.