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.
Gingival recession and inadequate keratinized tissue are common mucogingival problems that can compromise periodontal health. Free gingival graft (FGG) therapy is considered the gold standard for increasing keratinized tissue; however, dimensional shrinkage of the graft during the healing process remains a significant clinical challenge. The survival and success of the graft depend heavily on rapid revascularization. This randomized controlled clinical trial aims to investigate whether the adjunctive use of biological agents can minimize graft shrinkage and enhance soft tissue healing. All eligible patients will initially receive non-surgical Phase 1 periodontal therapy, including professional plaque removal and oral hygiene instructions. During the surgical phase, a partial-thickness recipient bed will be prepared in the mandibular incisor region. A free gingival graft of approximately 1 to 1.5 mm thickness will be harvested from the palatal donor site. Depending on the randomization assignment: In the first experimental group, the harvested FGG will be hydrated in injectable platelet-rich fibrin (i-PRF), which is obtained from the patient's own venous blood via centrifugation, prior to being sutured to the recipient bed. In the second experimental group, the FGG will be hydrated in a 0.8% hyaluronic acid (HA) gel before fixation. In the control group, the FGG will be applied and sutured conventionally without the use of any additional biological agents. Following graft fixation, a periodontal dressing will be applied to protect the recipient site, and a custom surgical stent combined with a hemostatic sponge will be used to stabilize the palatal donor site. Patients will be prescribed postoperative medications (antibiotics, analgesics, and antibacterial mouthwash) and advised on a soft diet. Standardized clinical photographs and digital image analysis software will be utilized to accurately measure graft dimensional changes during the follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
The 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.
The 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.
The 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.
University of Health Sciences, Gülhane Faculty of Dentistry
Ankara, Turkey (Türkiye)
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.
Time frame: Baseline, 1 month, and 3 months post-operation
Probing Depth (PD)
Measurement of Probing Depth (PD) in millimeters using a UNC-15 periodontal probe.
Time frame: Baseline, 1 month, and 3 months post-operation
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.
Time frame: 7 days, 14 days, 21 days, 1 month, and 3 months post-operation
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.
Time frame: 3 months post-operation
Clinical Attachment Level (CAL)
Measurement of clinical attachment level in millimeters using a UNC-15 periodontal probe.
Time frame: Baseline, 1 month, and 3 months post-operation
Gingival Recession Height
Measurement of gingival recession height in millimeters using a UNC-15 periodontal probe.
Time frame: Baseline, 1 month, and 3 months post-operation.
Keratinized Tissue Height
Measurement of keratinized tissue height in millimeters using a UNC-15 periodontal probe.
Time frame: Baseline, 1 month, and 3 months post-operation.
Keratinized Tissue Thickness
Keratinized tissue thickness was measured using a size 25 endodontic spreader equipped with a silicone stopper. Following tissue penetration, the distance from the tip of the spreader to the stopper was measured using a digital electronic caliper in millimeters.
Time frame: Baseline and 3 months post-operation.
Zeynep Cansu GÜZEL, DDS (Doctor of Dental Surgery)
CONTACT
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