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

Nguyen Van Khuong

Status: Not yet enrolling

Conditions: Dental Implants

Treatments: Procedure: Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants; Procedure: Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants

Study type: Interventional

Funder types: Other

Identifiers

NCT07346391

25309-DHYD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Conventional Free Gingival Graft (FGG)

Experimental group

Description:

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 mucosa

Treatment:

Procedure: Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants

Combining a strip free gingival graft with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa

Experimental group

Description:

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.

Treatment:

Procedure: Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants