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Insufficient Keratinized GingivaNCT06867055

Evaluation of the Effectiveness of Different Procedures on Palatinal Wound Healing After Free Gingival Graft Surgery.

A study testing Injectable platelet-rich fibrin (I-PRF) and 0.8% hyaluronic acide (HA) in people with Insufficient Keratinized Gingiva, run by SEVAL CEYLAN ŞEN at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to help determine the appropriate method to accelerate wound healing at the free gingival graft donor site and to minimize the patient's postoperative complaints. Read more about this study

Who is it for?
Ages 18 to 58 yearsHealthy volunteers can take part
Conditions the study is for
Insufficient Keratinized Gingiva
What is being tested?
Injectable platelet-rich fibrin (I-PRF) and 0.8% hyaluronic acide (HA)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2023to 15 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

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 to 58 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • patients older than 18 and
  • systemically healthy patients,
  • who didn't use drugs that affect wound healing,
  • didn't have coagulation disorder and nausea, and
  • were not anti-inflammatory drug allergy sufferers.

Who cannot join

  • patients who had systematic disorders (such as diabetes, hypertension, radiotherapy, chemotherapy),
  • patients who were former or active smokers and alcohol users,
  • pregnant and breastfeeding, lactation, menstruation,
  • patients with poor oral hygiene, and patients who didn't attend regular check-ups.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Health Sciences University Gulhane Faculty of Dentistry

    Ankara, Ankara, (533) 316-1232

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Efficacy of Injectable Platelet Rich Fibrin (I-TZF) Impregnated Gelatin Sponge and 0.8% Hyaluronic Acid Gel Impregnated Gelatin Sponge on Clinical Healing of Palatinal Wound Healing After Free Gingival Grafting.

This study aimed to help determine the appropriate method to accelerate wound healing at the free gingival graft donor site and to minimize the patient's postoperative complaints. For this purpose, gelatin sponge impregnated with injectable platelet-rich fibrin (I-PRF), gelatin sponge impregnated with 0.8% polyvinylpyrrolidone sodium hyaluronate (HA) gel, and standard gelatin sponge application were compared to the secondary wound site on the palate.

The main questions aimed at being answered are:

Read more
  • Does the use of I-PRF or HA accelerate wound healing in patients?
  • Does the use of I-PRF or HA reduce pain and burning symptoms?
  • For this purpose, gelatin sponge impregnated with injectable platelet-rich fibrin (I-PRF), gelatin sponge impregnated with 0.8% polyvinylpyrrolidone sodium hyaluronate (HA) gel, and standard gelatin sponge application were compared to the secondary wound site on the palate.

Participants will:

  • They will record whether there is pain and burning for 7 days after the operation.
  • They will record if there is bleeding in the palate area.
  • They will write the number of painkillers they use daily.
  • They will visit the clinic on the 3rd, 5th, 7th, 14th, 21st, 28th days and 1st and 3rd months after the operation.
Being tested
Injectable platelet-rich fibrin (I-PRF), 0.8% hyaluronic acide (HA), control group
Keywords
wound healing, analog pain scale, free gingival graft, injectable plathelet rich fibrin, palate, Wound epithelization, topical hyaluronic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injectable platelet-rich fibrin (I-PRF)Biological

    I-PRF were produced with 11-mL plastic tubes (16*10 mm) using a Nuve NF 200 centrifugation device with a rotor angulation with a radius of 101 mm at the clot (Nuve NF 200, Nuve Industrial Materials Manufacturing and Trade Company, Ankara, Türkiye). The I-PRF at the top of the tube was collected with a syringe and transferred to the metal bowl. It was held for 20-25 min for polymerization.

  • 0.8% hyaluronic acide (HA)Drug

    0.8% polyvinylpyrrolidone sodium hyaluronate (HA) (Gengigel Prof, Ricerfarma SRL.) gel was impregnated on a sterile gelatin sponge and sutured with 4/0 silk suture (4/0 Sterisilk, SSM Medical Equipment, Türkiye) on the palate area and bleeding control was provided with SX bioplast plate.

  • control groupOther

    Sterile gelatin sponge was sutured with 4/0 silk suture (4/0 Sterisilk, SSM Medical Equipment, Turkey) in the palatal region where FGG was taken and bleeding was controlled with SX bioplast plate.

Study groups in NCT06867055
Study groupRoleWhat they receive
I-PRFExperimental]. In the first test group, based on the g force, peripheral blood was collected in sterile plain plastic tubes (Beliver Industrial Estate, Pylmouth, UK.) and centrifuged to obtain I-PRF [16]. Injectable platelet-rich fibrin was produced using a protocol of 2500 RPM for 3 min (RCF-max = 509.53 g) I-PRF were produced with 11-mL plastic tubes (16*10 mm) using a Nuve NF 200 centrifugation device with a rotor angulation with a radius of 101 mm at the clot (Nuve NF 200, Nuve Industrial Materials Manufacturing and Trade Company, Ankara, Türkiye). The I-PRF at the top of the tube was collected with a syringe and transferred to the metal bowl. It was held for 20-25 min for polymerization. In the I-PRF test group, I-PRF was impregnated on a sterile gelatin sponge and sutured with 4/0 silk suture (4/0 Sterisilk, SSM Medical Equipment, Türkiye) on the palate area and bleeding was controlled with SX bioplast plate.
Receives: Biological: Injectable platelet-rich fibrin (I-PRF)
Gengigel (HA)Experimental0.8% polyvinylpyrrolidone sodium hyaluronate (HA) (Gengigel Prof, Ricerfarma SRL.) gel was impregnated on a sterile gelatin sponge and sutured with 4/0 silk suture (4/0 Sterisilk, SSM Medical Equipment, Türkiye) on the palate area and bleeding control was provided with SX bioplast plate.
Receives: Drug: 0.8% hyaluronic acide (HA)
ControlExperimentalOnly sterile gelatin sponge was sutured with 4/0 silk suture (4/0 Sterisilk, SSM Medical Equipment, Turkey) in the palatal region where FGG was taken and bleeding was controlled with SX bioplast plate.
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Landry Wound Healing Index (WHI)

    The primary result expected from the study is that the healing of the palatinal region left for secondary healing is faster in the I-PRF and 0.8% HA groups compared to the control group.

    The primary outcome of the study was to measure the palatal wound healing status using the Landry Wound Healing Index (WHI) (Landry RG (1985) Efectiveness of benzydamine HC1 in the treatment of periodontal post-surgical patients. Faculty of Dentistry, University of Toronto), which grades the wound healing on a scale of the 3rd, 7th, 14th, 21st, and 28th days postoperatively. This index, which has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, granulation tissue presence, incision margins' epithelialization, and amount of suppuration.

    Measured: 1st, 3rd, 7th, 14th, 21st, 28th days and 1st and 3rd month after the surgical procedure

Secondary outcomes (10)
  1. pain and burn (Visual Analog Scale)

    The secondary result expected from the study is that postoperative pain and burning are less in the I-PRF and 0.8% HA groups compared to the control group.

    The secondary outcomes of the study were to measure patients' perception of pain, discomfort while chewing, and burning sensation after FGG harvesting using a numerical rating scale (VAS) from 0 (no pain, no discomfort while chewing, no burning sense) to 10 (the worst pain imaginable, extreme discomfort while chewing, extreme burning sense) between days 1 and 7, and the amount of analgesic consumption between days 1 and 7 postoperatively.

    Measured: First 7 day after the surgical procedure

  2. Tissue color match (CM)

    Tissue color match (CM) was assessed with adjacent and contralateral palatal tissue (0-no color matching to 10-excellent color matching)

    Measured: 1st, 3rd, 7th, 14th, 21st, 28th days and 1st and 3rd month after the surgical procedure

  3. postoperative bleeding

    The patients were asked to keep a record of whether there was any bleeding in the palatal region, and at the same time, the presence of postoperative bleeding, also known as delayed bleeding (DB), was recorded as present (+) or absent (-) on the days when the patients came to the follow up appointments.

    Measured: 1st, 3rd, 5th, and 7th day after the surgical procedure.

  4. H2O2 bubbling

    The epithelialization of the palatal region was recorded according to the application of 3% hydrogen peroxide to the region and whether there was foaming or not, and was calculated as a percentage (H2O2 bubbling). Complete epithelization (CE) was also evaluated clinically by monitoring the surface characteristics and clarity of the wound contour and recorded as "yes" or "no".

    Measured: 1st, 3rd, 7th, 14th, 21st, 28th days after the surgical procedure

  5. Oral Health Related Quality of Life (OHRQoL)

    Oral Health Related Quality of Life (OHRQoL) was administered on the 7th and 14th days after the surgical procedures to analyse how the person's daily physical-social life and mental health status were affected. This scale developed by McGrath and Bedi evaluates the effects of oral health on quality of life in both positive and negative domains. The scale includes 16 questions consisting of 4 different categories. The categories consist of current symptoms (2 questions) and physical (5 questions), psychological (5 questions) and social (4 questions) conditions. The questions in the OHRQOL-TR questionnaire are scored on a Likert scale with values between 1 and 5 (such as 'very bad' (score 1), 'bad' (score 2), 'none' (score 3), 'good' (score 4) or 'very good' (score 5)). When the scores of 16 questions are totalled, there is a value in the range of 16-80. The reliability and validity of the Turkish version of the scale was proved and reported in the study conducted by Mumcu et al.

    Measured: 7th and 14th days after the surgical procedure.

  6. Number of analgesics taken

    Patients were informed that the number of analgesics theytook for post-operative pain relief was recorded for 7 days

    Measured: First 7 day after the surgical procedure.

  7. palatal soft-tissue thickness (PSTT)

    The PSTT in the harvested area was measured after theadministration of local anaesthesia.The measurement was made approximately 5 mm apical to the gingival marginof the first premolar using a #15 endodontic reamer. Thepenetration depth was measured using a digital caliper. Themeasurements were obtained before harvesting the FGG and at 1 and 3 months after the operation.The graft thickness was measured in the same way at the middle points of all four edges of the graft. The mean of theobtained values was calculated and considered to be the graft thickness. The dimensions of the graft were standardized using a sterile aluminium foil template of 7 * 12 mm.

    Measured: Initial, 1st and 3rd month after the surgical procedure

  8. tissue consistency

    After the operation, the consistency of the donor area in the palatal region was marked to be soft and firm.

    Measured: On the 3rd, 7th, 14th and 21st days after surgery

  9. Palate sensitivity

    Palate sensitivity was measured by using a numerical rating scale (VAS) from 0 (no sensitivity) to 10 (most sensitivity) on the 7th, 14th and 21st days after surgery

    Measured: On the 7th, 14th and 21st days after surgery

  10. Loss of sensation

    Loss of sensation was recorded as none (0), moderate (1), and severe (2) on the 3rd, 7th, 14th, 21st, 28th day, 1st month, and 3rd month after the operation.

    Measured: n the 3rd, 7th, 14th, 21st, 28th day, 1st month, and 3rd month after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start15 May 2023
  3. Primary completion15 Aug 2025
  4. Study completion15 Sep 2025

Resources

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
Model description
This study was designed as a randomized, single blind, parallel group controlled clinical trial.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06867055
Sponsor's protocol ID
Seval1
Status last verified
Mar 2026
First submitted
4 Mar 2025
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ceylan Sen S, Sarac Atagun O, Ustaoglu G, Ozcan E. Comparative evaluation of hyaluronic acid and injectable platelet-rich fibrin in palatal wound healing: a randomized clinical trial. BMC Oral Health. 2025 Oct 29;25(1):1693. doi: 10.1186/s12903-025-07183-9.

    PubMed 41162972

Questions about this trial

What is this clinical trial studying?

A study testing Injectable platelet-rich fibrin (I-PRF) and 0.8% hyaluronic acide (HA) in people with Insufficient Keratinized Gingiva, run by SEVAL CEYLAN ŞEN 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 4 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: finished, as of the sponsor's last update on 4 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Landry Wound Healing Index (WHI) (time frame: 1st, 3rd, 7th, 14th, 21st, 28th days and 1st and 3rd month after the surgical procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06867055, which also lists 1 linked publication.

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 Mar 2026.

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