This clinical trial aims to evaluate the clinical effectiveness of combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) for increasing keratinized mucosa around dental implants. The study compares this combined technique with the conventional free gingival graft (FGG) method through three primary objectives: 1. comparing the increase in keratinized mucosal height at immediate post-op, 1, 4, and 6 months; 2. assessing post-operative pain levels at 1, 3, 7, and 14 days; 3. evaluating soft tissue aesthetic outcomes at 4 and 6 months post-surgery.
Pre-operative phase: Eligible patients undergo clinical examination and medical record documentation. Written informed consent is obtained prior to enrollment. Participants are randomly assigned by drawing one of 22 sealed envelopes: odd numbers are allocated to Group A (strip free gingival graft with PRF) and even numbers to Group B (conventional free gingival graft). Baseline intraoral and extraoral photographs and intraoral scans (PLY format) are obtained. Intra-operative phase: * Group A (Experimental): PRF is prepared from venous blood. A strip free gingival graft is harvested from the palate and placed at the recipient site in combination with PRF. * Group B (Control): A conventional free gingival graft is harvested from the palate and placed at the recipient site. Post-operative phase: Follow-up visits are conducted at days 1, 3, 7, and 14, and at 1, 4, and 6 months post-surgery. At 1 month, healing abutments are placed and prosthetic treatment begins. Keratinized mucosa changes are assessed using pre- and post-operative intraoral scans. Post-operative pain is evaluated using the Visual Analog Scale (VAS), and soft tissue aesthetic outcomes are assessed at 4 and 6 months using a standardized aesthetic score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
Venous blood is collected using a butterfly needle and 10ml tubes to prepare the PRF membrane. A keratinized mucosa strip of appropriate dimensions is harvested from the patient's palate. The strip free gingival graft and PRF membrane are then sutured and stabilized at the recipient site.
A surgical procedure where a graft consisting of epithelium and connective tissue is harvested from the palate and transplanted to the peri-implant area to increase the width and height of keratinized
Assessment of the increase in peri-implant keratinized mucosa width
KMW was assessed at the mid-buccal aspect of each implant, measuring the distance from the MGJ to the mucosal margin/alveolar zenith using STL surface data at 1, 4, and 6 months.
Time frame: 1, 4, 6 months
Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)
"The esthetic outcome of the peri-implant soft tissue is evaluated using the modified Pink Esthetic Score (PES) as described by Fürhauser et al. (2005). The assessment compares the grafted area to the adjacent natural tooth based on seven parameters: Soft tissue color difference, soft tissue texture difference, grafted site margins-mesial side, distal side, level of mucogingival junction, keloid-like appearance. Each parameter is assigned a score of 0, 1, or 2 (0 being the lowest, 2 being the highest/most esthetic). The total PES score ranges from 0 to 14, where a higher score indicates a superior esthetic result
Time frame: 4 months and 6 months post-operatively
Post-operative pain intensity measured by Visual Analog Scale (VAS)
Pain intensity is measured on a Visual Analog Scale from 0 (no pain) to 10 (unbearable pain). Participants will be asked to mark their level of discomfort at each time point.
Time frame: 1, 3, 7 and 14 days post-operatively
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