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

NCT06867055 | Completed DMC

• 1 other identifier: Seval1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Keywords

wound healing; analog pain scale; free gingival graft; injectable plathelet rich fibrin; palate; Wound epithelization; topical hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Landry Wound Healing Index (WHI)

  The primary result expected from the study is that the healing of the palatinal region left for secondary healing is faster in the I-PRF and 0.8% HA groups compared to the control group. The primary outcome of the study was to measure the palatal wound healing status using the Landry Wound Healing Index (WHI) (Landry RG (1985) Efectiveness of benzydamine HC1 in the treatment of periodontal post-surgical patients. Faculty of Dentistry, University of Toronto), which grades the wound healing on a scale of the 3rd, 7th, 14th, 21st, and 28th days postoperatively. This index, which has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, granulation tissue presence, incision margins' epithelialization, and amount of suppuration.

  1st, 3rd, 7th, 14th, 21st, 28th days and 1st and 3rd month after the surgical procedure

Secondary Outcomes (10)

• pain and burn (Visual Analog Scale)

  First 7 day after the surgical procedure

• Tissue color match (CM)

  1st, 3rd, 7th, 14th, 21st, 28th days and 1st and 3rd month after the surgical procedure

• postoperative bleeding

  1st, 3rd, 5th, and 7th day after the surgical procedure.

• H2O2 bubbling

  1st, 3rd, 7th, 14th, 21st, 28th days after the surgical procedure

• Oral Health Related Quality of Life (OHRQoL)

  7th and 14th days after the surgical procedure.

Study Arms (3)

I-PRF

EXPERIMENTAL

\]. 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.

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

Gengigel (HA)

EXPERIMENTAL

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.

Drug: 0.8% hyaluronic acide (HA)

Control

EXPERIMENTAL

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.

Other: control group

Interventions

Injectable platelet-rich fibrin (I-PRF) 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.

I-PRF

0.8% hyaluronic acide (HA) 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.

Gengigel (HA)

control group 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.

Control

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SEVAL CEYLAN ŞEN: lead
• İNCİ PHARMA: collaborator

Study Sites (1)

Health Sciences University Gulhane Faculty of Dentistry

Ankara, Ankara, (533) 316-1232, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 41162972 DERIVED

MeSH Terms

Interventions

proliferation regulatory factors, human urine; Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• SEVAL CEYLAN ŞEN, Assist Prof.

  Gülhane Diş Hekimliği Fakültesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist Prof. Dr.

Model Details: This study was designed as a randomized, single blind, parallel group controlled clinical trial.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: May 15, 2023
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)