Evaluation of the Effectiveness of Different Procedures on Palatinal Wound Healing After Free Gingival Graft Surgery.

Saglik Bilimleri Universitesi

Status: Active, not recruiting

Conditions: Insufficient Keratinized Gingiva

Treatments: Other: control group; Biological: Injectable platelet-rich fibrin (I-PRF); Drug: 0.8% hyaluronic acide (HA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06867055

Seval1

Details and patient eligibility

About

This study aimed to help determine the appropriate method to accelerate wound healing at the free gingival graft donor site and to minimize the patient's postoperative complaints. For this purpose, gelatin sponge impregnated with injectable platelet-rich fibrin (I-PRF), gelatin sponge impregnated with 0.8% polyvinylpyrrolidone sodium hyaluronate (HA) gel, and standard gelatin sponge application were compared to the secondary wound site on the palate.

The main questions aimed at being answered are:

• Does the use of I-PRF or HA accelerate wound healing in patients?
• Does the use of I-PRF or HA reduce pain and burning symptoms?
• For this purpose, gelatin sponge impregnated with injectable platelet-rich fibrin (I-PRF), gelatin sponge impregnated with 0.8% polyvinylpyrrolidone sodium hyaluronate (HA) gel, and standard gelatin sponge application were compared to the secondary wound site on the palate.

Participants will:

• They will record whether there is pain and burning for 7 days after the operation.
• They will record if there is bleeding in the palate area.
• They will write the number of painkillers they use daily.
• They will visit the clinic on the 3rd, 5th, 7th, 14th, 21st, 28th days and 1st and 3rd months after the operation.

Enrollment: 67 patients

Sex: All

Ages: 18 to 58 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Inclusion criteria for the study were;
• patients older than 18 and
• systemically healthy patients,
• who didn't use drugs that affect wound healing,
• didn't have coagulation disorder and nausea, and
• were not anti-inflammatory drug allergy sufferers.

Exclusion criteria

• Exclusion criteria for the study were;
• patients who had systematic disorders (such as diabetes, hypertension, radiotherapy, chemotherapy),
• patients who were former or active smokers and alcohol users,
• pregnant and breastfeeding, lactation, menstruation,
• patients with poor oral hygiene, and patients who didn't attend regular check-ups.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 3 patient groups

I-PRF

Experimental group

Description:

\]. In the first test group, based on the g force, peripheral blood was collected in sterile plain plastic tubes (Beliver Industrial Estate, Pylmouth, UK.) and centrifuged to obtain I-PRF \[16\]. Injectable platelet-rich fibrin was produced using a protocol of 2500 RPM for 3 min (RCF-max = 509.53 g) I-PRF were produced with 11-mL plastic tubes (16\*10 mm) using a Nuve NF 200 centrifugation device with a rotor angulation with a radius of 101 mm at the clot (Nuve NF 200, Nuve Industrial Materials Manufacturing and Trade Company, Ankara, Türkiye). The I-PRF at the top of the tube was collected with a syringe and transferred to the metal bowl. It was held for 20-25 min for polymerization. In the I-PRF test group, I-PRF was impregnated on a sterile gelatin sponge and sutured with 4/0 silk suture (4/0 Sterisilk, SSM Medical Equipment, Türkiye) on the palate area and bleeding was controlled with SX bioplast plate.

Treatment:

Biological: Injectable platelet-rich fibrin (I-PRF)

Gengigel (HA)

Experimental group

Description:

0.8% polyvinylpyrrolidone sodium hyaluronate (HA) (Gengigel Prof, Ricerfarma SRL.) gel was impregnated on a sterile gelatin sponge and sutured with 4/0 silk suture (4/0 Sterisilk, SSM Medical Equipment, Türkiye) on the palate area and bleeding control was provided with SX bioplast plate.

Treatment:

Drug: 0.8% hyaluronic acide (HA)

Control

Experimental group

Description:

Only sterile gelatin sponge was sutured with 4/0 silk suture (4/0 Sterisilk, SSM Medical Equipment, Turkey) in the palatal region where FGG was taken and bleeding was controlled with SX bioplast plate.

Treatment:

Other: control group