Effects of Platelet Concentrates on Palatal Wound Healing

NCT04097509 | Completed

• 1 other identifier: 2018/46
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change of Epithelialization of wound in % at different time points

  Completion of wound epithelialization was evaluated clinically using H2O2 foaming test. After the wound area was dried with gauze, 3% of hydrogen peroxide (H2O2) was applied to the wound with an injector. The result of H2O2 application was evaluated as bubbling within / without palate. The absence of foaming indicates that epithelialization is complete

  Epithelialization was evaluated on the 3rd, 7th, 14th day and 1st month.

• Change of color, contour and distortion of wound in the total score of scale in numerical at different time points

  The Modified Manchester Scar (MMS) Scale was used to assess the color, contour, and distortion of the wound . The color of the wound was classified as a perfect match (score 0), mild mismatch (score 1), or obvious mismatch (score 2) compared to the neighboring mucosa. The contour of the wound was evaluated as similar (score 0), slightly raised or indented (score 1) and hypertrophic (score 2) when compared to surrounding tissues. Wound distortion was evaluated as no distortion (score 0), mild distortion (score 1) and obvious distortion (score 2) . The sum of the scores in the three categories shows the repair score of the wound, with a total score ranging from 0 to 6, with lower scores indicating better repair.

  MMS was evaluated on the 3rd, 7th, 14th day and 1st month.

• Change of redness, presence of bleeding, granulation tissue, epithelialization and suppuration in % at different time points

  Wound healing was evaluated using the Landry, Turnbull, Howley (LTH) index, which classifies the healing process according to redness, presence of bleeding, granulation tissue, epithelialization and suppuration. Improvement in this index was scored between 1 (very poor recovery) and 5 (excellent recovery).The sum of the scores shows the repair score of the wound. Evaluation of wound healing process with LTH index was performed on the 3rd, 7th and 14th days and on the 1st and 3rd month controls.

  LTH was evaluated on the 3rd, 7th, 14th day and 1st month.

Secondary Outcomes (1)

• change of Postoperative Pain Evaluation (VAS) in total score of scale in numerical at different time points

  VAS was evaluated on the 3rd, 7th, 14th day and 1st month.

Study Arms (3)

autologous fibrin glue (AFG) group

EXPERIMENTAL

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

Biological: AFG application on palatinal wound healing

injectable platelet rich fibrin (i-PRF) group

EXPERIMENTAL

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

Biological: i-PRF application on palatinal wound healing

Control Group

PLACEBO COMPARATOR

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

Other: control

Interventions

AFG application on palatinal wound healing 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.

autologous fibrin glue (AFG) group

i-PRF application on palatinal wound healing 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.

injectable platelet rich fibrin (i-PRF) group

control OTHER

no application

Control Group

Eligibility Criteria

• Age: 18 Years - 53 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University, Faculty of Dentistry, Department of Periodontics,

Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Blood Platelet Disorders; Gingival Recession

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• MUSTAFA Ö USLU, Asst. Prof.

  Inonu University, Faculty of Dentistry, Department of Periodontics,

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient and investigator were blinded to the applications
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Faculty of Dentistry, Department of Periodontology

Model Details: This study was designed as a randomized, controlled clinical trial. Three groups were randomly assigned as one control and two test groups. A total of 36 patients (12 patients in each group) were included in the study. In the control group, only moist sterile tamponade was applied following graft removal to the palatinal donor area. In the test groups, polymerized AFG or polymerized i-PRF were applied to the donor area. After these procedures, donor palate was closed with sterile aluminum foil and periodontal pat in all 3 groups.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: May 1, 2018
• Primary Completion: February 10, 2019
• Study Completion: June 10, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)