ClinicalTrials.gg
Not yet recruitingNCT07804888IPRF-HA-FGGUpdated Sep 4, 2026

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

An interventional study of Free gingival graft and Free Gingival Graft with i-PRF in Lack of Keratinized Tissue, Mucogingival Surgery and Gingival Recession, sponsored by Saglik Bilimleri Universitesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 69 studies in Gingival Recession with a site in Turkey — 14 open to participants now, 15 under way, none of them phase 3. Gingival Recession · Turkey.

Planned enrollment
15th of 56
45 · median 36
Started
2026
with 4 others
No phase
52 of 69
12 open now
Primary completion
2027-01
later than 11 of 14 live
Registered
69th of 69
by date

Among the 69 studies in Gingival Recession with a site in Turkey, this one is the 15th largest by planned enrollment of the 56 interventional ones, is one of 5 that started in 2026, is one of 52 with no phase, reaches primary completion later than 11 of the 14 other live ones, and was the 69th registered.

By phase

69 studies; the count open now beside each. This study's row is marked.

No phasethis study52 · 12 open
Observational13 · 2 open
Phase 11 · 0 open
Phase 1/21 · 0 open
Phase 21 · 0 open
Phase 31 · 0 open

By the year they started

First in 2010; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 36 across the 56 interventional studies, 80 across the 13 observational. Of the 52 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 69 studies in Gingival Recession with a site in Turkey, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Lack of Keratinized Tissue
  • Mucogingival Surgery
  • Gingival Recession

Browse trials for

Keywords

  • free gingival graft
  • I-PRF
  • hyaluronic acid
  • injectable platelet-rich fibrin
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 18 years or older.
  • Systemically healthy patients with no 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 to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients with systemic diseases that may affect wound healing (e.g., uncontrolled diabetes mellitus, 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    FGG + i-PRF

    Free gingival graft combined with injectable platelet-rich fibrin (i-PRF).

    Procedure: Free Gingival Graft with i-PRF

  • Experimental
    FGG + Hyaluronic Acid

    Free gingival graft combined with 0.8% hyaluronic acid gel.

    Procedure: Free Gingival Graft with Hyaluronic Acid

  • Active comparator
    Conventional FGG (Control)

    Conventional free gingival graft applied without any additional biological agents.

    Procedure: Free gingival graft

Interventions

  • ProcedureFree 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.

    Also known as: Conventional FGG

  • ProcedureFree 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.

    Also known as: FGG + injectable platelet-rich fibrin

  • ProcedureFree 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.

    Also known as: FGG with 0.8% HA gel, Gingigel

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1 month, and 3 months post-operation

Secondary outcomes

  1. Probing Depth (PD)

    Measurement of Probing Depth (PD) in millimeters using a UNC-15 periodontal probe.

    Time frame: Baseline, 1 month, and 3 months post-operation

  2. 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.

    Time frame: 7 days, 14 days, 21 days, 1 month, and 3 months post-operation

  3. 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.

    Time frame: 3 months post-operation

  4. Clinical Attachment Level (CAL)

    Measurement of clinical attachment level in millimeters using a UNC-15 periodontal probe.

    Time frame: Baseline, 1 month, and 3 months post-operation

  5. Gingival Recession Height

    Measurement of gingival recession height in millimeters using a UNC-15 periodontal probe.

    Time frame: Baseline, 1 month, and 3 months post-operation.

  6. Keratinized Tissue Height

    Measurement of keratinized tissue height in millimeters using a UNC-15 periodontal probe.

    Time frame: Baseline, 1 month, and 3 months post-operation.

  7. 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.

    Time frame: Baseline and 3 months post-operation.

Other outcomes

  1. Postoperative Pain

    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.

    Time frame: Up to 7 days post-operation

  2. Patient-Reported Comfort Level: Postoperative Bleeding

    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.

    Time frame: Up to 14 days post-operation

  3. Patient-Reported Comfort Level: Postoperative Edema

    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.

    Time frame: Up to 14 days post-operation

  4. Patient-Reported Comfort Level: Difficulty Speaking

    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).

    Time frame: Up to 14 days post-operation

  5. Patient-Reported Comfort Level: Difficulty Eating

    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

    Time frame: Up to 14 days post-operation

07

Study locations

1 site
  • University of Health Sciences, Gülhane Faculty of Dentistry
    Ankara, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

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

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jan 2027, 4 months later.

Of 233 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 4 months is below that.

Counting every sponsor, half of 235 studies reached it within 19 months; a quarter within 11 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2026
First posted
Sep 4, 2026
StartEst.
Sep 2026
Primary completionEst.
Jan 2027
CompletionEst.
Mar 2027
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07804888
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Zeynep Cansu GÜZEL, DDS (Doctor of Dental Surgery)
Contact
zeynepcansu.guzel@sbu.edu.tr
+90 312 567 15 00 ext. 4931
Zeynep Cansu GÜZEL, DDS (Doctor of Dental Surgery)
Contact
guzelcns@gmail.com
+90 553 221 38 36
Gülbahar USTAOĞLU, Professor
principal investigator · University of Health Sciences, Gülhane Faculty of Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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