Comparison of the Effects of Injectable Platelet-rich Fibrin and Low-dose Laser Applications on Palatal Wound Healing.

NCT06744270 | Completed

• 1 other identifier: 2024/83
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Free gingival graft; Injectable platelet-rich fibrin; low-dose laser therapy

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  The effects of i-PRF and low-dose laser groups on wound healing and patient quality of life will be evaluated statistically compared to each other and the control group.

  4 mounth

Study Arms (3)

Control group

NO INTERVENTION

The group in which no procedure was performed on the palatal wound area after free gingival grafting

i-PRF group

EXPERIMENTAL

Immediately after the SDG operation, the venous blood taken from the patient will be centrifuged for 3 minutes at 2300 rpm in a centrifuge (PC-O2, Process for PRF, Nice, France) and two layers will be obtained: the lower layer is red blood cells and the upper layer is i-PRF. The i-PRF in the upper part of the tube will be collected with a syringe and transferred to the metal godet. 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.

Other: i-PRF group

low-dose laser group

EXPERIMENTAL

In the laser group, low-dose laser will be applied to the palatal donor area immediately after the FGG operation, on the 3rd, 5th, 7th and 14th days.

Other: low-dose laser group

Interventions

i-PRF group OTHER

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.

i-PRF group

low-dose laser group OTHER

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.

low-dose laser group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18
• Systemically healthy,
• Not taking any medication that affects wound healing,
• Without clotting disorders or nausea,
• Patients who are not allergic to anti-inflammatory drugs.

You may not qualify if:

• Patients with systemic diseases (such as diabetes, hypertension, radiotherapy, chemotherapy),
• Patients who smoke or are active smokers and drink alcohol,
• Pregnant and breastfeeding women,
• Those with poor oral hygiene.

Sponsors & Collaborators

• Esra Bozkurt: lead
• Kahramanmaras Sutcu Imam University: collaborator

Study Sites (1)

Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Periodontics

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

Related Publications (7)

• Ozcan M, Ucak O, Alkaya B, Keceli S, Seydaoglu G, Haytac MC. Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e270-e278. doi: 10.11607/prd.3226.

  PMID: 28817141 BACKGROUND

• Kim SH, Tramontina VA, Papalexiou V, Luczsyzyn SM, De Lima AA, do Prado AM. Bismuth subgallate as a topical haemostatic agent at the palatal wounds: a histologic study in dogs. Int J Oral Maxillofac Surg. 2012 Feb;41(2):239-43. doi: 10.1016/j.ijom.2011.12.002. Epub 2011 Dec 29.

  PMID: 22209184 BACKGROUND

• Ustaoglu G, Ercan E, Tunali M. The role of titanium-prepared platelet-rich fibrin in palatal mucosal wound healing and histoconduction. Acta Odontol Scand. 2016 Oct;74(7):558-564. doi: 10.1080/00016357.2016.1219045. Epub 2016 Aug 19.

  PMID: 27538770 BACKGROUND

• Wang HL, Bunyaratavej P, Labadie M, Shyr Y, MacNeil RL. Comparison of 2 clinical techniques for treatment of gingival recession. J Periodontol. 2001 Oct;72(10):1301-11. doi: 10.1902/jop.2001.72.10.1301.

  PMID: 11699470 BACKGROUND

• Wennstrom J, Pini-Prato G. Mucogingival therapy-periodontal plastic surgery. In: Lindhe J, Karring T, Lang N (eds). Clinical Periodontlogy and Implant Dentistry, 4th ed. Oxford, Blackwell Munksgaard, 2003: 588-92

  BACKGROUND

• Newman MG, Takei H, Klokkevold PR, Carranza FA. Carranza's Clinical Periodontology, 12th ed. St. Louis, Missouri, 2012.

  BACKGROUND

• Bozkurt E, Ozdemir EC. The efficacy of injectable platelet-rich fibrin versus photobiomodulation therapy on palatal wound healing: a randomized, controlled, clinical trial. Clin Oral Investig. 2025 Oct 15;29(11):512. doi: 10.1007/s00784-025-06613-w.

  PMID: 41091419 DERIVED

Related Links

• Inonu University Clinical Research Ethics Committee

Study Officials

• Esra Bozkurt

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Dr.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 20, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)