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

April 18, 2026 updated by: Nguyen Van Khuong

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 4 and 6 months post-surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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, 3, 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 3 and 6 months using a standardized aesthetic score.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • VIỆT NAM
      • HỒ CHÍ MINH, VIỆT NAM, Vietnam, 123456789
        • Phòng Khám Chuyên Khoa Răng Hàm Mặt Đại Học Y Dược Thành Phố Hồ Chí Minh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)
Time Frame: 4 months and 6 months post-operatively

"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
4 months and 6 months post-operatively
Post-operative pain intensity measured by Visual Analog Scale (VAS)
Time Frame: 1, 3, 7 and 14 days post-operatively
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.
1, 3, 7 and 14 days post-operatively
Assessment of the increase in peri-implant keratinized mucosa width
Time Frame: 1, 3, 6 months
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, 3, and 6 months.
1, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nguyen Van Khuong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25309-DHYD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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