CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
i-PRF group +1 moreother
Likely dose
Not stated in record
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Search/NCT06744270
NCT06744270N/ACompleted

Inonu University Clinical Research Ethics Committee

Esra Bozkurt·interventional·Posted Dec 20, 2024·Updated Dec 20, 2024

In Brief

A clinical study evaluating i-PRF group and low-dose laser group for Healthy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The investigators will evaluate the findings related to pain and bleeding, quality of life after surgery, and wound healing in participants who received injectable platelet-rich fibrin (i-PRF) and low-dose laser therapy to the palatal region after free gingival graft (FGG) surgery, compared to participants who did not receive any medication/active substance other than surgery. The investigators aim to evaluate whether i-PRF and low-dose laser treatments are superior to each other and to participants who did not receive any medication/active substance. The investigators predict that i-PRF and low-dose laser therapy will accelerate wound healing, reduce postoperative pain, and improve the patient's quality of life after surgery. The investigators do not expect any adverse effects from the application of i-PRF and low-dose laser therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesTurkey (Türkiye)

Timeline

N/ACompletedFinished
20252026
First PostedDec 20, 2024
Enrollment StartJul 1, 2024
Primary CompletionDec 1, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 1.5 years ago

Interventions

i-PRF groupother

In the i-PRF group, 10 ml of venous blood taken from the patient immediately after the SDG operation will be transferred to a tube that does not contain any anticoagulant. The collected venous blood will be centrifuged for 3 minutes at 2300 rpm in a centrifuge device and two layers will be obtained: the lower layer is red blood cells and the upper layer is i-PRF. 20-25 minutes will be waited for polymerization. After polymerization, the polymerized i-PRF will be applied to the wound surface in the donor area. Following the operation, patients will be called for check-ups on the 3rd, 5th, 7th, 14th, 21st and 30th days and their photographs will be taken and the following parameters will be evaluated. * Pain assessment and analgesic intake * H2O2 Foaming Test (to assess epithelialization) * Wound healing will be assessed using the Image program from patient photographs * Edema and erythema scores will be assessed visually.

low-dose laser groupother

In the laser group, low-dose laser will be applied to the palatal donor area immediately after SDG surgery, on the 3rd, 5th, 7th and 14th days. A GaAlAs diode laser (CHEESETM, GIGAA Laser, Wuhan Gigaa Optronics Technology Co., Ltd., China) with a wavelength of 810 nm and a low-dose diode laser application tip with a fiber diameter of 950 µm will be used. A low-dose diode laser will be applied to the surgical operation area in accordance with the manufacturer's instructions, with a non-contact regional 0.3 W power and an intensity of 4 J/cm2 in continuous mode for 1 min. Following the operation, patients will be called for check-ups on the 3rd, 5th, 7th, 14th, 21st and 30th days, and their photographs will be taken and the following parameters will be evaluated. • Pain assessment and analgesic intake * H2O2 Foaming Test (to assess epithelialization) * Wound healing will be assessed using Image program from patient photographs * Edema and erythema scores will be assessed visually.