About this trial
The purpose of this clinical trial is to evaluate the effects of injectable platelet-rich fibrin (i-PRF) and hyaluronic acid (HA) gel on clinical healing and graft shrinkage when used in addition to Free Gingival Graft (FGG) surgery. The study involves patients with gingival recession and insufficient keratinized tissue. Participants will be randomly divided into three groups: FGG with i-PRF application, FGG with HA gel application, Conventional FGG alone (Control group). The main goal is to compare the amount of graft shrinkage and evaluate clinical wound healing parameters between these groups over a 3-month follow-up period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18 years or older.
Systemically healthy patients with no contraindications for periodontal surgery.
Patients presenting with gingival recession and/or inadequate width of keratinized tissue requiring Free Gingival Graft (FGG) therapy.
Non-smokers.
Disqualifiers
Patients with systemic diseases that may affect wound healing (e.g., uncontrolled diabetes mellitus, autoimmune disorders).
Pregnant or lactating individuals.
Patients with poor oral hygiene.
Current smokers or tobacco users.
Trial design
Parallel
Treatments tested in this trial
Free gingival graft
Procedure/SurgeryThe free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and directly applied and sutured to the recipient site without any additional biological agents.
Free Gingival Graft with i-PRF
Procedure/SurgeryThe free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and hydrated in injectable platelet-rich fibrin (i-PRF) before fixation at the recipient site. i-PRF is prepared by centrifuging the patient's venous blood at 2500 rpm for 3 minutes.
Free Gingival Graft with Hyaluronic Acid
Procedure/SurgeryThe free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and soaked in 0.8% hyaluronic acid (HA) gel before fixation at the recipient site.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Graft Shrinkage
Graft shrinkage will be evaluated by calculating the surface area of the graft in square millimeters using standardized clinical photographs and ImageJ software. The percentage of shrinkage is calculated with the formula: ((Immediate post-operative graft area - Follow-up graft area ) / Immediate post-operative graft area) x 100.
Secondary outcomes
Probing Depth (PD)
Measurement of Probing Depth (PD) in millimeters using a UNC-15 periodontal probe.
Wound Healing Index
Soft tissue healing will be assessed using the Landry, Turnbull, and Howley Index. Scores range from 1 (very poor) to 5 (excellent) based on parameters such as tissue color, bleeding on palpation, presence of granulation tissue, and incision margins.
Root Coverage Esthetic Score (RES)
Objective evaluation of the esthetic outcomes using the Root Coverage Esthetic Score (RES). The system evaluates five anatomical variables (gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color). The total score ranges from 0 to 10, with 10 representing a perfect esthetic outcome. Gingival Margin (GM): Scored as 0, 3, or 6 points depending on the amount of root coverage. Marginal Tissue Contour (MTC): 1 point if regular/proper, 0 points if irregular. Soft Tissue Texture (STT): 1 point if harmonious with the adjacent tissue, 0 points if not. Mucogingival Junction Alignment (MGJ): 1 point if aligned with the adjacent MGJ, 0 points if not. Gingival Color (GC): 1 point if there is a color match with the adjacent tissue, 0 points if not. The total score ranges from a minimum of 0 to a maximum of 10, where higher scores mean a better esthetic outcome.
Clinical Attachment Level (CAL)
Measurement of clinical attachment level in millimeters using a UNC-15 periodontal probe.
Other outcomes
Postoperative Pain
Postoperative pain intensity will be evaluated daily by the patients using a 10 cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Patient-Reported Comfort Level: Postoperative Bleeding
Patient-reported comfort levels regarding postoperative bleeding will be assessed daily using a 5-point Likert scale. The scale ranges from 1 to 5 (1 = Very dissatisfied, 5 = Very satisfied), where higher scores indicate greater aesthetic satisfaction. minimum 1 to a maximum of 5, where higher scores mean a better outcome.
Patient-Reported Comfort Level: Postoperative Edema
Patient-reported comfort levels regarding postoperative edema will be assessed daily using a 5-point Likert scale. The scale ranges from 1 to 5 (1 = Very dissatisfied, 5 = Very satisfied), where higher scores indicate greater aesthetic satisfaction. minimum 1 to a maximum of 5, where higher scores mean a better outcome.
Patient-Reported Comfort Level: Difficulty Speaking
Patient-reported comfort level regarding difficulty speaking will be assessed daily using a 5-point Likert scale. The score ranges from a minimum of 1 to a maximum of 5 (1 = Very dissatisfied/Severe discomfort, 5 = Very satisfied/No discomfort), where higher scores mean a better outcome (greater patient comfort).
Sponsors and contacts
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