An interventional study of Free Gingival Graft (FGG) and Injectable Platelet-Rich Fibrin (i-PRF) in Graft Shrinkage and Gingival Recession, Localized, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Treatment
This randomized clinical trial aims to evaluate whether injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) can reduce graft shrinkage after free gingival graft procedures. Free gingival grafts are commonly used to increase the width of keratinized tissue around teeth, but the graft often shrinks during healing. In this study, patients will receive standard free gingival graft surgery with or without additional i-PRF or laser therapy. The goal is to determine whether these treatments improve healing and help maintain the size of the graft.
This randomized controlled clinical trial investigates the effects of injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) on the shrinkage of free gingival grafts (FGG) used to treat gingival recession. Free gingival grafting is commonly performed to increase the width of keratinized tissue around teeth, but shrinkage during healing can reduce clinical outcomes.
The study included 48 systemically healthy adult patients with Cairo Class I gingival recession in mandibular anterior teeth. Participants were randomly assigned to one of three groups: control (FGG alone), i-PRF (FGG + platelet-rich fibrin), or LLLT (FGG + low-level laser therapy). Ethical approval was obtained from the Clinical Research Ethics Committee of Inonu University (Protocol No: 2024/84), and all participants provided written informed consent. The study protocol was registered at ClinicalTrials.gov (NCT06744270) and conducted according to CONSORT 2010 guidelines.
All patients received preoperative periodontal treatment, including plaque removal and oral hygiene instructions. Free gingival grafts were harvested from the palatal region and adapted to the recipient site, then stabilized with sutures. In the i-PRF group, autologous platelet-rich fibrin gel was applied to the graft surface. In the LLLT group, laser therapy was applied immediately after surgery and on postoperative days 3, 5, 7, and 14. The control group received no additional treatment beyond standard grafting.
Postoperative care included use of a periodontal dressing, chlorhexidine mouthwash, analgesics as needed, and oral hygiene instructions after suture removal. Clinical evaluations included gingival recession depth, keratinized tissue height, probing depth, clinical attachment level, and graft area measurements at baseline, 1, 3, and 6 months. Edema, erythema, and patient-reported pain were also assessed during follow-up.
The primary outcome of the study was graft shrinkage, calculated as the percentage decrease in graft area over time. Secondary outcomes included clinical parameters and patient-reported postoperative morbidity. All measurements were performed by calibrated, blinded examiners to ensure reliability.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 48 is above the median of 30 across 368 interventional studies indexed under Gingival Recession.
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Exclusion Criteria:
Patients receive free gingival graft only without additional treatment.
Procedure: Free Gingival Graft (FGG)
Patients receive free gingival graft with injectable platelet-rich fibrin applied to the graft surface.
Procedure: Free Gingival Graft (FGG) · Device: Low-Level Laser Therapy (LLLT)
Patients receive free gingival graft with low-level laser therapy applied immediately after surgery and on postoperative days 3, 5, 7, and 14.
Procedure: Free Gingival Graft (FGG) · Biological: Injectable Platelet-Rich Fibrin (i-PRF)
Standard free gingival graft procedure performed without additional treatments.
Autologous platelet-rich fibrin gel is applied to the graft surface after free gingival graft surgery to potentially reduce graft shrinkage.
Low-level laser therapy is applied to the graft site immediately after surgery and on postoperative days 3, 5, 7, and 14 to potentially improve healing and reduce graft shrinkage.
Graft Area Shrinkage (%)
Change in graft surface area, expressed as percentage shrinkage from baseline. Standardized clinical photographs taken at baseline and at postoperative 1, 3, and 6 months were analyzed using calibrated digital image analysis software (ImageJ). The graft borders were traced, and surface area (mm²) was calculated. Each measurement was repeated three times, and the mean value was used. Shrinkage percentage was calculated using the formula: Shrinkage % = \[(baseline area - follow-up area) / baseline area\] × 100.
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Root Coverage Percentage (%)
Percentage of root coverage obtained at 6 months. Root coverage was calculated from changes in gingival recession depth (RD) using the formula: Root Coverage % = \[(baseline RD - RD at 6 months) / baseline RD\] × 100. RD was defined as the distance from the CEJ to the gingival margin and measured using a manual periodontal probe.
Time frame: Baseline and 6 months postoperatively.
Gingival Recession Depth (RD)
Change in gingival recession depth measured in millimeters.
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Keratinized Tissue Height (KTH)
Change in keratinized tissue height measured in millimeters.
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Probing Depth (PD)
Change in probing depth measured in millimeters.
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Clinical Attachment Level (CAL)
Change in clinical attachment level measured in millimeters.
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Oedema Score in the Recipient Site
Oedema was scored clinically in the recipient area using a 0-4 ordinal scale (0 = none; 1 = mild, intraoral oedema limited to the surgical site; 2 = moderate, extraoral oedema limited to the surgical site; 3 = significant, extraoral oedema extending beyond the surgical site; 4 = severe, extraoral oedema extending beyond the surgical site with limited mouth opening). Examinations were performed by a calibrated and blinded examiner. Higher scores indicate more severe oedema. Unit of Measure: Units on a scale (0-4)
Time frame: Postoperative days 3, 5, 7, 14, 21, and 28.
Erythema Score in the Recipient Site
Erythema was scored clinically in the recipient area using a 0-4 ordinal scale (0 = none, tissues fully pink; 1 = mild, \<25% of tissues red; 2 = moderate, 25-50% of tissues red; 3 = significant, 50-75% of tissues red; 4 = severe, \>75% of tissues red). Examinations were performed by a calibrated and blinded examiner. Higher scores indicate greater severity of erythema.
Time frame: Postoperative days 3, 5, 7, 14, 21, and 28.
Pain Intensity (VAS Score)
Postoperative pain intensity was assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = maximum tolerable pain. Patients recorded their pain level daily during the first postoperative week. Higher scores indicate greater pain intensity.
Time frame: First postoperative week.
Analgesic Consumption
The number of analgesic tablets taken during the first postoperative week was recorded by each patient on a provided daily log form. Higher values indicate greater postoperative analgesic use.
Time frame: First postoperative week.
Plan to share: No — Individual participant data will not be shared to ensure patient privacy and confidentiality.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Kahramanmaras Sutcu Imam University