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

NCT ID: NCT06867055

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-04-15

Brief Summary

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.

Conditions

Insufficient Keratinized Gingiva

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

I-PRF

\]. 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.

Group Type: EXPERIMENTAL

Injectable platelet-rich fibrin (I-PRF)

Intervention Type: BIOLOGICAL

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.

Gengigel (HA)

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.

Group Type: EXPERIMENTAL

0.8% hyaluronic acide (HA)

Intervention Type: DRUG

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.

Control

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.

Group Type: EXPERIMENTAL

control group

Intervention Type: OTHER

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.

Interventions

Injectable platelet-rich fibrin (I-PRF)

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.

Intervention Type: BIOLOGICAL

0.8% hyaluronic acide (HA)

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.

Intervention Type: DRUG

control group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

SEVAL CEYLAN ŞEN

Assist Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEVAL CEYLAN ŞEN, Assist Prof.

Role: PRINCIPAL_INVESTIGATOR

Gülhane Diş Hekimliği Fakültesi

Locations

Health Sciences University Gulhane Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ceylan Sen S, Sarac Atagun O, Ustaoglu G, Ozcan E. Comparative evaluation of hyaluronic acid and injectable platelet-rich fibrin in palatal wound healing: a randomized clinical trial. BMC Oral Health. 2025 Oct 29;25(1):1693. doi: 10.1186/s12903-025-07183-9.

Reference Type: DERIVED

PMID: 41162972 (View on PubMed)

Other Identifiers

Seval1

Identifier Type: -

Identifier Source: org_study_id