Clinical trial NCT04097509: Effects of Platelet Concentrates on Palatal Wound Healing
Official title: Comparison of the Effects of Different Platelet Concentrates on Palatal Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Platelets; Defect
Periodontal Inflammation
Gingival Recession
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change of Epithelialization of wound in % at different time points
timeFrame: Epithelialization was evaluated on the 3rd, 7th, 14th day and 1st month.
measure: Change of color, contour and distortion of wound in the total score of scale in numerical at different time points
timeFrame: MMS was evaluated on the 3rd, 7th, 14th day and 1st month.
measure: Change of redness, presence of bleeding, granulation tissue, epithelialization and suppuration in % at different time points
timeFrame: LTH was evaluated on the 3rd, 7th, 14th day and 1st month.
Secondary outcomes:
measure: change of Postoperative Pain Evaluation (VAS) in total score of scale in numerical at different time points
timeFrame: VAS was evaluated on the 3rd, 7th, 14th day and 1st month.
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University, Faculty of Dentistry, Department of Periodontics,
Study officials:
affiliation: Inonu University, Faculty of Dentistry, Department of Periodontics,
name: MUSTAFA Ö USLU, Asst. Prof.
role: STUDY_DIRECTOR
References: