Augmentation of Peri-implant Keratinized Mucosa Using a Combination of Free Gingival Graft Strip With Platelet-Rich Fibrin

Clinical Effectiveness of Combining Free Gingival Strip Graft With Platelet-Rich Fibrin for Peri-Implant Keratinized Mucosa Augmentation

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, 3, and 6 months;
2. assessing post-operative pain levels at 1, 3, 7, and 14 days;
3. evaluating soft tissue aesthetic outcomes at 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, 3, and 6 months post-surgery. At 1 month, healing abutments are placed and prosthetic treatment begins and impressions were taken 2 weeks later. In another 2 weeks, the final restorations were delivered. 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 6 months using a standardized aesthetic score.

Inclusion Criteria:

• Patients meeting the following criteria are eligible for the study:

  • Prosthetic Phase: Patients scheduled for the prosthetic phase of dental implant treatment.
  • Keratinized Mucosa: Keratinized mucosa height (buccal or lingual) of less than 2 mm around the implant.
  • Systemic Health: Systemic health status classified as ASA I or II according to the American Society of Anesthesiologists classification.
  • Oral Hygiene: Good oral hygiene, defined by a mean full-mouth plaque index (PlI) of ≤ 1.

Exclusion Criteria:

• Patients meeting any of the following criteria will be excluded from the study:

  • Systemic Conditions: Presence of systemic diseases or use of medications known to affect the oral mucosa or gingival health.
  • Periodontal Health: Untreated periodontal disease and/or peri-implant diseases.
  • Surgical History: History of mucogingival surgery at the intended surgical site.
  • Pregnancy/Lactation: Pregnant or breastfeeding women.
  • Oral Hygiene: Poor oral hygiene, defined by a mean full-mouth plaque index (PlI) > 1.
  • Smoking: Current smokers.