Effects of Platelet Concentrates on Palatal Wound Healing

NCT ID: NCT04097509

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-06-10

Brief Summary

Platelet concentrates used in palatal wound healing have been reported to accelerate wound healing and reduce postoperative patient discomfort. The use of elet platelet rich fibrin '(PRF) in the palatal donor site after FGG surgery has been shown to provide significant benefits in terms of wound healing parameters and postoperative comfort. In a study using a platelet rich plasma (PRP) with a different platelet concentration, PRP was found to accelerate wound healing and shorten the healing time. In another study using titanium-prepared platelet rich fibrin (T-PRF) for palatal wound healing, it accelerated the wound healing process and reached the initial level of soft tissue thickness in the donor region at the end of 6 months. In the literature, there are few studies using platelet concentrates in palatal wound healing and only some concentrates (PRP, PRF, T-PRF) are used. The aim of this study is to compare the effects of injectable platelet rich fibrin (i-PRF), which are autologous fibrin glue (AFG) and injectable platelet concentrates, on palatal wound healing. The findings obtained from this study will contribute to the literature in determining the product and method that will provide optimal postoperative patient comfort and wound healing.

Detailed Description

Attached gingiva plays an important role in maintaining periodontal health. In the presence of inadequate attached gingiva, periodontal tissue inflammation, root sensitivity, root caries and gingival recessions are caused due to mucogingival stress in the related area and oral hygiene which is not provided adequately. In such cases, inadequate attached gingival width should be increased with mucogingival periodontal plastic surgery.

Free gingival graft (FGG) is accepted as the most commonly used mucogingival procedure in increasing the attached gingival, because of its predictable surgical outcome, simple technique and its application in large areas of operation. In the free gingival graft operation, the recipient bed is prepared in the area with insufficient attached gingiva. Free gingival grafts containing epithelial and connective tissue from the donor area are applied to this recipient bed in appropriate dimensions . Palatal region is the most preferred donor site in terms of anatomical advantage, ideal tissue thickness and wide keratinized band removal. The secondary wound in the donor site after FGG heals in 2-4 weeks and may cause problems that affect patient comfort such as paresthesia, herpetic lesion, mucocele, bleeding and pain in the postoperative period. Different products such as hemostatic agents, low-dose laser treatments, herbal products, ozonated oil, antibacterial / antiseptic agents, bioactive materials and platelet concentrates have been tested to accelerate wound healing and prevent these problems. Studies on the determination of the product and method that provide optimal postoperative patient comfort and wound healing from such products, whose effects on wound healing are known, are ongoing.

Platelet concentrates used in palatal wound healing have been reported to accelerate wound healing and reduce postoperative patient discomfort. The use of elet platelet rich fibrin '(PRF) in the palatal donor site after FGG surgery has been shown to provide significant benefits in terms of wound healing parameters and postoperative comfort. In a study using a platelet rich plasma (PRP) with a different platelet concentration, PRP was found to accelerate wound healing and shorten the healing time. In another study using titanium-prepared platelet rich fibrin (T-PRF) for palatal wound healing, it accelerated the wound healing process and reached the initial level of soft tissue thickness in the donor region at the end of 6 months. In the literature, there are few studies using platelet concentrates in palatal wound healing and only some concentrates (PRP, PRF, T-PRF) are used. The aim of this study is to compare the effects of injectable platelet rich fibrin (i-PRF), which are autologous fibrin glue (AFG) and injectable platelet concentrates, on palatal wound healing. The findings obtained from this study will contribute to the literature in determining the product and method that will provide optimal postoperative patient comfort and wound healing.

In this randomized, controlled clinical study, 36 patients in need of FGG were divided into three groups. AFG (n=12) or i-PRF (n=12) was applied to donor sites and compared to control group (n=12). Wound healing with H2O2 test, VAS, MMS scale and LTH index were evaluated on the 3rd, 7th, 14th day and 1st month. The bleeding status was evaluated on 3rd and 7th days. Palatal tissue thickness was measured at baseline, 1st month and 3rd month.

AFG and i-PRF have positive effects on the healing process by accelerating wound healing and reducing postoperative morbidity.

Conditions

Wound Heal; Platelets; Defect; Periodontal Inflammation; Gingival Recession

Study Design

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

Study Groups

autologous fibrin glue (AFG) group

In the test groups, polymerized AFG was applied to the palatinal donor area. Donor palate was closed with sterile aluminum foil and periodontal pack

Group Type: EXPERIMENTAL

AFG application on palatinal wound healing

Intervention Type: BIOLOGICAL

9 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. In the protocol, venous blood collected in the tube was centrifuged for 2 minutes at 2700 rpm (approximately 692 g) in a special centrifuge (Medifuge, Silfradent, Italy) to obtain two layers: the lower layer of red blood cells and the upper layer of AFG. The AFG at the top of the tube was collected by means of an injector and transferred to the metal godet. It was held for 15-20 minutes for polymerization. After polymerization occurred, the polymerized AFG in the metal gum was applied to the wound surface in the donor site . No suture or tissue glue was used. Adhesive properties of AFG were utilized.

injectable platelet rich fibrin (i-PRF) group

In the test groups, polymerized i-PRF was applied to the donor area. Donor palate was closed with sterile aluminum foil and periodontal pack.

Group Type: EXPERIMENTAL

i-PRF application on palatinal wound healing

Intervention Type: BIOLOGICAL

10 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. Based on G force, collected venous blood were centrifuged at 2300 rpm (about 241 g) in a centrifuge (PC-O2, Process for PRF, Nice, France) for 3 minutes to obtain two layers: The two layers are the lower layer of red blood cells and the upper layer of i-PRF. The i-PRF at the top of the tube was collected with a syringe and transferred to the metal godet. It was held for 20-25 minutes for polymerization. After the polymerization, the polymerized i-PRF was applied to the wound surface in the donor site. No suture or tissue glue was used. Adhesive properties of AFG were utilized.

Control Group

In the control group, only moist sterile tamponade was applied following graft removal to the palatinal donor area. Donor palate was closed with sterile aluminum foil and periodontal pack

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: OTHER

no application

Interventions

AFG application on palatinal wound healing

9 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. In the protocol, venous blood collected in the tube was centrifuged for 2 minutes at 2700 rpm (approximately 692 g) in a special centrifuge (Medifuge, Silfradent, Italy) to obtain two layers: the lower layer of red blood cells and the upper layer of AFG. The AFG at the top of the tube was collected by means of an injector and transferred to the metal godet. It was held for 15-20 minutes for polymerization. After polymerization occurred, the polymerized AFG in the metal gum was applied to the wound surface in the donor site . No suture or tissue glue was used. Adhesive properties of AFG were utilized.

Intervention Type: BIOLOGICAL

i-PRF application on palatinal wound healing

10 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. Based on G force, collected venous blood were centrifuged at 2300 rpm (about 241 g) in a centrifuge (PC-O2, Process for PRF, Nice, France) for 3 minutes to obtain two layers: The two layers are the lower layer of red blood cells and the upper layer of i-PRF. The i-PRF at the top of the tube was collected with a syringe and transferred to the metal godet. It was held for 20-25 minutes for polymerization. After the polymerization, the polymerized i-PRF was applied to the wound surface in the donor site. No suture or tissue glue was used. Adhesive properties of AFG were utilized.

Intervention Type: BIOLOGICAL

control

no application

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • Patients older than age 18

• Patients with good oral hygiene
• Patients who do not use drugs that affect wound healing
• Patients who are systemically healthy
• Patients who are non-smokers
• Patients who do not have coagulation disorder
• Patients who do not have nausea
• Patients who are not anti-inflammatory drug allergy sufferers

Exclusion Criteria

• • Patients who have systematic disorders such as (diabetes, hypertension, radiotherapy, chemotherapy, etc.)

• Patients who use any medication that may affect wound healing
• Patients with coagulation disorders
• Patients who are smokers and alcohol users
• Patients who are pregnant and breastfeeding
• Patients with poor oral hygiene
• Patients who have nausea
• Patients who are anti-inflammatory drug allergy sufferers
• Patients who do not attend regular check-ups

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 53 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

mustafa özay uslu

Assistant professor, Faculty of Dentistry, Department of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MUSTAFA Ö USLU, Asst. Prof.

Role: STUDY_DIRECTOR

Inonu University, Faculty of Dentistry, Department of Periodontics,

Locations

Inonu University, Faculty of Dentistry, Department of Periodontics,

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018/46

Identifier Type: -

Identifier Source: org_study_id