Clinical trial NCT06567548: Clinical Comparison of Alb-PRF Vs PRF on Postoperative Morbidity Following FGG Harvesting
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Palate; Wound
Keywords: PRF
Alb-PRF
FGG
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain (PP)
timeFrame: VAS will be recorded daily for day 1, 3,7, and 14
Secondary outcomes:
measure: Indirect postoperative pain
timeFrame: for 7 days postoperatively
measure: Tissue color match (TCM)
timeFrame: will be assessed on day 3, day 7, day 14, day 21, and day 28
measure: Complete wound re-epithelialization (CWE)
timeFrame: day 28
measure: Wound clinical healing area
timeFrame: will be assessed on day 3, day 7, day 14, day 21, and day 28
measure: Delayed wound bleeding (DWB)
timeFrame: day 7
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Enji Mahmoud, Phd
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Sarah Elbanna, Phd
role: STUDY_DIRECTOR
References: