Clinical trial NCT06867055: Evaluation of the Effectiveness of Different Procedures on Palatinal Wound Healing After Free Gingival Graft Surgery.
Official title: Evaluation of the Efficacy of Injectable Platelet Rich Fibrin (I-TZF) Impregnated Gelatin Sponge and 0.8% Hyaluronic Acid Gel Impregnated Gelatin Sponge on Clinical Healing of Palatinal Wound Healing After Free Gingival Grafting.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insufficient Keratinized Gingiva
Keywords: wound healing
analog pain scale
free gingival graft
injectable plathelet rich fibrin
palate
Wound epithelization
topical hyaluronic acid
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a randomized, single blind, parallel group controlled clinical trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Landry Wound Healing Index (WHI)
timeFrame: 1st, 3rd, 7th, 14th, 21st, 28th days and 1st and 3rd month after the surgical procedure
Secondary outcomes:
measure: pain and burn (Visual Analog Scale)
timeFrame: First 7 day after the surgical procedure
measure: Tissue color match (CM)
timeFrame: 1st, 3rd, 7th, 14th, 21st, 28th days and 1st and 3rd month after the surgical procedure
measure: postoperative bleeding
timeFrame: 1st, 3rd, 5th, and 7th day after the surgical procedure.
measure: H2O2 bubbling
timeFrame: 1st, 3rd, 7th, 14th, 21st, 28th days after the surgical procedure
measure: Oral Health Related Quality of Life (OHRQoL)
timeFrame: 7th and 14th days after the surgical procedure.
measure: Number of analgesics taken
timeFrame: First 7 day after the surgical procedure.
measure: palatal soft-tissue thickness (PSTT)
timeFrame: Initial, 1st and 3rd month after the surgical procedure
measure: tissue consistency
timeFrame: On the 3rd, 7th, 14th and 21st days after surgery
measure: Palate sensitivity
timeFrame: On the 7th, 14th and 21st days after surgery
measure: Loss of sensation
timeFrame: n the 3rd, 7th, 14th, 21st, 28th day, 1st month, and 3rd month after the operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Sciences University Gulhane Faculty of Dentistry
Study officials:
affiliation: Gülhane Diş Hekimliği Fakültesi
name: SEVAL CEYLAN ŞEN, Assist Prof.
role: PRINCIPAL_INVESTIGATOR
References: