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

NCT ID: NCT07346391

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-24
• Study Completion Date: 2026-07-01

Brief Summary

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.

Detailed 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.

Conditions

Dental Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional Free Gingival Graft (FGG)

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Interventions

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

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.

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nguyen Van Khuong

OTHER

Sponsor Role: lead

Responsible Party

Nguyen Van Khuong

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

25309-DHYD

Identifier Type: -

Identifier Source: org_study_id