Lack of Keratinized TissueIPRF-HA-FGGNCT07804888
Evaluation of the Effects of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Treatments, Administered in Addition to Free Gingival Graft Therapy, on Clinical Healing.
A study testing Free gingival graft, Free Gingival Graft with i-PRF and Free Gingival Graft with Hyaluronic Acid in people with Lack of Keratinized Tissue and Mucogingival Surgery, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lack of Keratinized Tissue, Mucogingival Surgery, Gingival Recession
- What is being tested?
- Free gingival graft, Free Gingival Graft with i-PRF and Free Gingival Graft with Hyaluronic Acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zeynep Cansu GÜZEL, DDS (Doctor of Dental Surgery) contact
Turkey (Türkiye)1 site
University of Health Sciences, Gülhane Faculty of Dentistry
Ankara
Zeynep Cansu GÜZEL, DDS, +90 312 567 15 00 ext. 4931, zeynepcansu.guzel@sbu.edu.tr
About this study
Official title: 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.
Read the 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.
- Being tested
- Free gingival graft, Free Gingival Graft with i-PRF, Free Gingival Graft with Hyaluronic Acid
- Keywords
- free gingival graft, I-PRF, hyaluronic acid, injectable platelet-rich fibrin
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graftProcedure or surgery
Also called Conventional FGG
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.
Free Gingival Graft with i-PRFProcedure or surgery
Also called FGG + injectable platelet-rich fibrin
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.
Free Gingival Graft with Hyaluronic AcidProcedure or surgery
Also called FGG with 0.8% HA gel, Gingigel
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.
| Study group | Role | What they receive |
|---|---|---|
| FGG + i-PRF | Experimental | Free gingival graft combined with injectable platelet-rich fibrin (i-PRF). Receives: Procedure: Free Gingival Graft with i-PRF |
| FGG + Hyaluronic Acid | Experimental | Free gingival graft combined with 0.8% hyaluronic acid gel. Receives: Procedure: Free Gingival Graft with Hyaluronic Acid |
| Conventional FGG (Control) | Active comparator | Conventional free gingival graft applied without any additional biological agents. Receives: Procedure: Free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Graft Shrinkage
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.
Measured: Baseline, 1 month, and 3 months post-operation
Secondary outcomes (7)
Probing Depth (PD)
Measurement of Probing Depth (PD) in millimeters using a UNC-15 periodontal probe.
Measured: Baseline, 1 month, and 3 months post-operation
Wound Healing Index
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.
Measured: 7 days, 14 days, 21 days, 1 month, and 3 months post-operation
Root Coverage Esthetic Score (RES)
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.
Measured: 3 months post-operation
Clinical Attachment Level (CAL)
Measurement of clinical attachment level in millimeters using a UNC-15 periodontal probe.
Measured: Baseline, 1 month, and 3 months post-operation
Gingival Recession Height
Measurement of gingival recession height in millimeters using a UNC-15 periodontal probe.
Measured: Baseline, 1 month, and 3 months post-operation.
Keratinized Tissue Height
Measurement of keratinized tissue height in millimeters using a UNC-15 periodontal probe.
Measured: Baseline, 1 month, and 3 months post-operation.
Keratinized Tissue Thickness
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.
Measured: Baseline and 3 months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lack of Keratinized TissueStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gülbahar USTAOĞLU, Professor, Principal investigator, University of Health Sciences, Gülhane Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804888
- Sponsor's protocol ID
- SBU-26-11
- Acronym
- IPRF-HA-FGG
- Status last verified
- Sep 2026
- First submitted
- 23 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Treatments, Administered in Addition to Free Gingival Graft Therapy, on Clinical Healing
- ClinicalTrials.gov ID
- NCT07804888
- Acronym / sponsor ID
- IPRF-HA-FGG / SBU-26-11
- Keywords
- free gingival graft, I-PRF, hyaluronic acid, injectable platelet-rich fibrin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FGG + i-PRF | Experimental | Procedure: Free Gingival Graft with i-PRFFree gingival graft combined with injectable platelet-rich fibrin (i-PRF). |
| FGG + Hyaluronic Acid | Experimental | Procedure: Free Gingival Graft with Hyaluronic AcidFree gingival graft combined with 0.8% hyaluronic acid gel. |
| Conventional FGG (Control) | Active comparator | Procedure: Free gingival graftConventional free gingival graft applied without any additional biological agents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free gingival graftAlso: Conventional FGGThe 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. | Procedure or surgery | Conventional FGG (Control) |
| Free Gingival Graft with i-PRFAlso: FGG + injectable platelet-rich fibrinThe 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. | Procedure or surgery | FGG + i-PRF |
| Free Gingival Graft with Hyaluronic AcidAlso: FGG with 0.8% HA gel, GingigelThe 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. | Procedure or surgery | FGG + Hyaluronic Acid |
Primary outcome
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.
7 secondary outcomes
Probing Depth (PD)
Time frame: 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
Root Coverage Esthetic Score (RES)
Time frame: 3 months post-operation
Clinical Attachment Level (CAL)
Time frame: Baseline, 1 month, and 3 months post-operation
Gingival Recession Height
Time frame: Baseline, 1 month, and 3 months post-operation.
Keratinized Tissue Height
Time frame: Baseline, 1 month, and 3 months post-operation.
Keratinized Tissue Thickness
Time frame: Baseline and 3 months post-operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep Cansu GÜZEL, DDS (Doctor of Dental Surgery) contact
Gülbahar USTAOĞLU, Professor principal investigator
University of Health Sciences, Gülhane Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft, Free Gingival Graft with i-PRF and Free Gingival Graft with Hyaluronic Acid in people with Lack of Keratinized Tissue and Mucogingival Surgery, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Cansu GÜZEL, DDS (Doctor of Dental Surgery) (+90 312 567 15 00 ext. 4931, zeynepcansu.guzel@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Graft Shrinkage (time frame: Baseline, 1 month, and 3 months post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.