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

July 17, 2026 updated by: Nguyen Van Khuong, University of Medicine and Pharmacy at Ho Chi Minh City

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 and mucosa thickness
Time Frame: 1, 3, 6 months
KMW and MT were assessed using STL surface data at 1, 3, and 6 months
1, 3, 6 months
Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)
Time Frame: 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 parameters: Soft tissue color difference, soft tissue texture difference, soft tissue contour difference.

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 6, where a higher score indicates a superior esthetic result
6 months post-operatively

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Medicine and Pharmacy at Ho Chi Minh City

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 24, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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