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

ConditionPalate; Wound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCairo University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

Smokers

Pregnant and lactating women

Patients with poor oral hygiene

Patients who had previous periodontal surgery in the area of interest

Trial design

Design model

Parallel

Treatments tested in this trial

  • control group

    Other intervention

    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 intervention

    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

    Other intervention

    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.

Treatment groups

39 Participants
are divided into 3 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Platelet-rich fibrin (PRF) groupActive comparator 1 intervention
Group C: Albumin Platelet Rich- Fibrin (Alb-PRF) group:Experimental treatment 1 intervention

Trial outcomes

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).

Time frame
VAS will be recorded daily for day 1, 3,7, and 14

Secondary outcomes

1

Indirect postoperative pain

Will be assessed indirectly by mean consumption of analgesics

Time frame
for 7 days postoperatively
2

Tissue color match (TCM)

The palatal mucosa's color using Visual analog Scale,VAS Scale (0-10) Qualitative Ordinal (VAS

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

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.

Time frame
day 28
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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