Evaluation of the Effects of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Treatments, Administered in Addition to Free Gingival Graft Therapy, on Clinical Healing. (IPRF-HA-FGG)

September 3, 2026 updated by: Saglik Bilimleri Universitesi

Evaluation of the Effects of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Treatments, Administered in Addition to Free Gingival Graft Therapy, on Clinical Healing

The purpose of this clinical trial is to evaluate the effects of injectable platelet-rich fibrin (i-PRF) and hyaluronic acid (HA) gel on clinical healing and graft shrinkage when used in addition to Free Gingival Graft (FGG) surgery. The study involves patients with gingival recession and insufficient keratinized tissue. Participants will be randomly divided into three groups: FGG with i-PRF application, FGG with HA gel application, Conventional FGG alone (Control group). The main goal is to compare the amount of graft shrinkage and evaluate clinical wound healing parameters between these groups over a 3-month follow-up period.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Gingival recession and inadequate keratinized tissue are common mucogingival problems that can compromise periodontal health. Free gingival graft (FGG) therapy is considered the gold standard for increasing keratinized tissue; however, dimensional shrinkage of the graft during the healing process remains a significant clinical challenge. The survival and success of the graft depend heavily on rapid revascularization.

This randomized controlled clinical trial aims to investigate whether the adjunctive use of biological agents can minimize graft shrinkage and enhance soft tissue healing.

All eligible patients will initially receive non-surgical Phase 1 periodontal therapy, including professional plaque removal and oral hygiene instructions.

During the surgical phase, a partial-thickness recipient bed will be prepared in the mandibular incisor region. A free gingival graft of approximately 1 to 1.5 mm thickness will be harvested from the palatal donor site.

Depending on the randomization assignment:

In the first experimental group, the harvested FGG will be hydrated in injectable platelet-rich fibrin (i-PRF), which is obtained from the patient's own venous blood via centrifugation, prior to being sutured to the recipient bed.

In the second experimental group, the FGG will be hydrated in a 0.8% hyaluronic acid (HA) gel before fixation.

In the control group, the FGG will be applied and sutured conventionally without the use of any additional biological agents.

Following graft fixation, a periodontal dressing will be applied to protect the recipient site, and a custom surgical stent combined with a hemostatic sponge will be used to stabilize the palatal donor site. Patients will be prescribed postoperative medications (antibiotics, analgesics, and antibacterial mouthwash) and advised on a soft diet. Standardized clinical photographs and digital image analysis software will be utilized to accurately measure graft dimensional changes during the follow-up period.

Study Type

Interventional

Enrollment (Estimated)

45

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 Contact

Study Contact Backup

  • Name: Zeynep Cansu GÜZEL, DDS (Doctor of Dental Surgery)
  • Phone Number: +90 553 221 38 36
  • Email: guzelcns@gmail.com

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals aged 18 years or older.
  • Systemically healthy patients with no contraindications for periodontal surgery.
  • Patients presenting with gingival recession and/or inadequate width of keratinized tissue requiring Free Gingival Graft (FGG) therapy.
  • Non-smokers.
  • Patients who provide written informed consent to participate in the study.

Exclusion Criteria:

  • Patients with systemic diseases that may affect wound healing (e.g., uncontrolled diabetes mellitus, autoimmune disorders).
  • Pregnant or lactating individuals.
  • Patients with poor oral hygiene.
  • Current smokers or tobacco users.
  • Patients who have received periodontal surgery in the designated surgical area within the last 6 months.

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: FGG + i-PRF
Free gingival graft combined with injectable platelet-rich fibrin (i-PRF).
Procedure: Free Gingival Graft with i-PRF
The free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and hydrated in injectable platelet-rich fibrin (i-PRF) before fixation at the recipient site. i-PRF is prepared by centrifuging the patient's venous blood at 2500 rpm for 3 minutes.
Other Names:
  • FGG + injectable platelet-rich fibrin
Experimental: FGG + Hyaluronic Acid
Free gingival graft combined with 0.8% hyaluronic acid gel.
Procedure: Free Gingival Graft with Hyaluronic Acid
The free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and soaked in 0.8% hyaluronic acid (HA) gel before fixation at the recipient site.
Other Names:
  • FGG with 0.8% HA gel, Gingigel
Active Comparator: Conventional FGG (Control)
Conventional free gingival graft applied without any additional biological agents.
Procedure: Free gingival graft
The free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and directly applied and sutured to the recipient site without any additional biological agents.
Other Names:
  • Conventional FGG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Graft Shrinkage
Time Frame: Baseline, 1 month, and 3 months post-operation
Graft shrinkage will be evaluated by calculating the surface area of the graft in square millimeters using standardized clinical photographs and ImageJ software. The percentage of shrinkage is calculated with the formula: ((Immediate post-operative graft area - Follow-up graft area ) / Immediate post-operative graft area) x 100.
Baseline, 1 month, and 3 months post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depth (PD)
Time Frame: Baseline, 1 month, and 3 months post-operation
Measurement of Probing Depth (PD) in millimeters using a UNC-15 periodontal probe.
Baseline, 1 month, and 3 months post-operation
Wound Healing Index
Time Frame: 7 days, 14 days, 21 days, 1 month, and 3 months post-operation
Soft tissue healing will be assessed using the Landry, Turnbull, and Howley Index. Scores range from 1 (very poor) to 5 (excellent) based on parameters such as tissue color, bleeding on palpation, presence of granulation tissue, and incision margins.
7 days, 14 days, 21 days, 1 month, and 3 months post-operation
Root Coverage Esthetic Score (RES)
Time Frame: 3 months post-operation

Objective evaluation of the esthetic outcomes using the Root Coverage Esthetic Score (RES). The system evaluates five anatomical variables (gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color). The total score ranges from 0 to 10, with 10 representing a perfect esthetic outcome.

Gingival Margin (GM): Scored as 0, 3, or 6 points depending on the amount of root coverage.

Marginal Tissue Contour (MTC): 1 point if regular/proper, 0 points if irregular.

Soft Tissue Texture (STT): 1 point if harmonious with the adjacent tissue, 0 points if not.

Mucogingival Junction Alignment (MGJ): 1 point if aligned with the adjacent MGJ, 0 points if not.

Gingival Color (GC): 1 point if there is a color match with the adjacent tissue, 0 points if not.

The total score ranges from a minimum of 0 to a maximum of 10, where higher scores mean a better esthetic outcome.
3 months post-operation
Clinical Attachment Level (CAL)
Time Frame: Baseline, 1 month, and 3 months post-operation
Measurement of clinical attachment level in millimeters using a UNC-15 periodontal probe.
Baseline, 1 month, and 3 months post-operation
Gingival Recession Height
Time Frame: Baseline, 1 month, and 3 months post-operation.
Measurement of gingival recession height in millimeters using a UNC-15 periodontal probe.
Baseline, 1 month, and 3 months post-operation.
Keratinized Tissue Height
Time Frame: Baseline, 1 month, and 3 months post-operation.
Measurement of keratinized tissue height in millimeters using a UNC-15 periodontal probe.
Baseline, 1 month, and 3 months post-operation.
Keratinized Tissue Thickness
Time Frame: Baseline and 3 months post-operation.
Keratinized tissue thickness was measured using a size 25 endodontic spreader equipped with a silicone stopper. Following tissue penetration, the distance from the tip of the spreader to the stopper was measured using a digital electronic caliper in millimeters.
Baseline and 3 months post-operation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: Up to 7 days post-operation
Postoperative pain intensity will be evaluated daily by the patients using a 10 cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Up to 7 days post-operation
Patient-Reported Comfort Level: Postoperative Bleeding
Time Frame: Up to 14 days post-operation
Patient-reported comfort levels regarding postoperative bleeding will be assessed daily using a 5-point Likert scale. The scale ranges from 1 to 5 (1 = Very dissatisfied, 5 = Very satisfied), where higher scores indicate greater aesthetic satisfaction. minimum 1 to a maximum of 5, where higher scores mean a better outcome.
Up to 14 days post-operation
Patient-Reported Comfort Level: Postoperative Edema
Time Frame: Up to 14 days post-operation
Patient-reported comfort levels regarding postoperative edema will be assessed daily using a 5-point Likert scale. The scale ranges from 1 to 5 (1 = Very dissatisfied, 5 = Very satisfied), where higher scores indicate greater aesthetic satisfaction. minimum 1 to a maximum of 5, where higher scores mean a better outcome.
Up to 14 days post-operation
Patient-Reported Comfort Level: Difficulty Speaking
Time Frame: Up to 14 days post-operation
Patient-reported comfort level regarding difficulty speaking will be assessed daily using a 5-point Likert scale. The score ranges from a minimum of 1 to a maximum of 5 (1 = Very dissatisfied/Severe discomfort, 5 = Very satisfied/No discomfort), where higher scores mean a better outcome (greater patient comfort).
Up to 14 days post-operation
Patient-Reported Comfort Level: Difficulty Eating
Time Frame: Up to 14 days post-operation
Patient-reported comfort level regarding difficulty eating will be assessed daily using a 5-point Likert scale. The score ranges from a minimum of 1 to a maximum of 5 (1 = Very dissatisfied/Severe discomfort, 5 = Very satisfied/No discomfort), where higher scores mean a better outcome (greater patient comfort). minimum 1 to a maximum of 5, where higher scores mean a better outcome
Up to 14 days post-operation

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Gülbahar USTAOĞLU, Professor, University of Health Sciences, Gülhane Faculty of Dentistry

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 23, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBU-26-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared. This includes the primary and secondary outcome measures (clinical periodontal parameters, graft shrinkage data, wound healing index scores, Root Coverage Esthetic Scores, and patient comfort data). Patient identities and any identifying information will remain strictly confidential and will not be shared.

IPD Sharing Time Frame

Data will become available beginning 3 months following article publication and will be accessible for up to 3 years.

IPD Sharing Access Criteria

Data will be shared with researchers who provide a methodologically sound proposal to achieve the specific aims outlined in the approved proposal. Requests should be directed to the principal investigator via email. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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