Free Gingival GraftNCT07072546
Chitosan and i-PRF in Palatal Wound Healing
A study testing free gingival graft + gelatin sponge, free gingival graft + chitosan and free gingival graft + chitosan and i-PRF in people with Free Gingival Graft and Wound Healing, run by Biruni University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of chitosan and injectable platelet-rich fibrin (i-PRF) on wound healing at the donor site following free gingival graft (FGG) procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Free Gingival Graft, Wound Healing, i-PRF
- What is being tested?
- free gingival graft + gelatin sponge, free gingival graft + chitosan and free gingival graft + chitosan and i-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Jul 2025to 10 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontally healthy
- Having good oral hygiene (plaque accumulation <20%)
- Requiring a free gingival graft (FGG) procedure in an area with insufficient keratinized gingiva width (<2 mm)
Who cannot join
- Having systemic diseases contraindicating surgical procedures,
- Uncontrolled diabetes (HbA1c > 7),
- Being pregnant or breastfeeding,
- Autoimmune and/or inflammatory diseases of the oral cavity,
- Active periodontal disease,
- Smokers (≥ 10 cigarettes per day)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cukurova University
Adana
Biruni University
Istanbul
About this study
Official title: Effects of Chitosan and i-PRF on Wound Healing After Palatal Graft Harvesting
This study aims to evaluate the effects of chitosan and injectable platelet-rich fibrin (i-PRF) on wound healing at the donor site following free gingival graft (FGG) procedures. The palatal donor area often experiences delayed healing and postoperative discomfort, motivating the search for effective biomaterials to enhance recovery and reduce patient morbidity. Although various approaches have been investigated, the combined application of chitosan and i-PRF has not yet been explored in this context.
The study examines three patient groups treated at the periodontology departments of Çukurova and Biruni University: one with gelatin sponge (control), one with chitosan, and one with chitosan infused with i-PRF. Parameters such as pain (VAS), bleeding, burning sensation, dietary changes, epithelialization (PEHI score), and color match were assessed over a 2-month follow-up.
The findings are expected to provide insights into whether i-PRF-enhanced chitosan offers superior healing outcomes and greater patient comfort compared to conventional methods.
- Conditions
- Free Gingival Graft, Wound Healing, i-PRF, Chitosan
- Being tested
- free gingival graft + gelatin sponge, free gingival graft + chitosan, free gingival graft + chitosan and i-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free gingival graft + gelatin spongeProcedure or surgery
Free gingival graft surgery and application of gelatin sponge to the palatal wound
free gingival graft + chitosanProcedure or surgery
free gingival graft surgery and application of chitosan to the palatal wound
free gingival graft + chitosan and i-PRFProcedure or surgery
free gingival graft surgery and application of chitosan and i-PRF to the palatal wound
| Study group | Role | What they receive |
|---|---|---|
| control | Other | control group Receives: Procedure: free gingival graft + gelatin sponge |
| chitosan | Active comparator | Not described Receives: Procedure: free gingival graft + chitosan |
| chitosan-iprf | Experimental | Not described Receives: Procedure: free gingival graft + chitosan and i-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatal early healing index
The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).
Measured: Day 7
Palatal early healing index
The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).
Measured: Day 14
Palatal early healing index
The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).
Measured: Day 28
Palatal early healing index
The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).
Measured: Day 56
Secondary outcomes (33)
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Measured: Day 1
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Measured: Day 3
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Measured: Day 7
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Measured: Day 14
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Measured: Day 28
Palatal Pain score
The degree of pain in the patient's palatal region will be evaluated using visual analogue scale (0-no pain to 10-severe pain).
Measured: Day 56
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this informations daily.
Measured: Day 1
Difficulty in chewing
The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 7
Difficulty in chewing
The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 14
Difficulty in chewing
The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 28
Difficulty in chewing
The degree of difficulty in chewing in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 56
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Measured: Day 2
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Measured: Day 3
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Measured: Day 4
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Measured: Day 5
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Measured: Day 6
Use of analgesics and palatal bleeding
Patients will be given a form and asked to record this information daily.
Measured: Day 7
Graft dimentions
The width, length, and thickness of the palatal graft will be measured using a periodontal probe and recorded.
Measured: Day 0
Color match
The color match at the donor site will be evaluated in comparison with the adjacent palatal area and the contralateral palatal arch by visual analogue scale (0-very bad to 10-excellent).
Measured: Day 14
Color match
The color match at the donor site will be evaluated in comparison with the adjacent palatal area and the contralateral palatal arch by visual analogue scale (0-very bad to 10-excellent).
Measured: Day 28
Color match
The color match at the donor site will be evaluated in comparison with the adjacent palatal area and the contralateral palatal arch by visual analogue scale (0-very bad to 10-excellent).
Measured: Day 56
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 1
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 3
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 7
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 14
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 28
Burning sensation
The degree of burning sensation in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 56
Changes in dietary habits
The degree of changes in dietary habits in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 1
Changes in dietary habits
The degree of changes in dietary habits in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 3
Changes in dietary habits
The degree of changes in dietary habits in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 7
Changes in dietary habits
The degree of changes in dietary habits in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 14
Changes in dietary habits
The degree of changes in dietary habits in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 28
Changes in dietary habits
The degree of changes in dietary habits in the patient's palatal region will be evaluated using visual analogue scale (0-no to 10-severe).
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start12 Jul 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Gingival GraftStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe 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
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Cukurova University
- Responsible party
- Principal investigator, Burcu KARADUMAN, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072546
- Sponsor's protocol ID
- Chitosan-iPRF
- Status last verified
- Jan 2026
- First submitted
- 7 Jul 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chitosan and i-PRF on Wound Healing After Palatal Graft Harvesting
- ClinicalTrials.gov ID
- NCT07072546
- Acronym / sponsor ID
- Chitosan-iPRF
- Conditions
- Free Gingival Graft, Wound Healing, i-PRF, Chitosan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Cukurova University
- Study start
- 12 Jul 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 18 Jul 2025 (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.
This study aims to evaluate the effects of chitosan and injectable platelet-rich fibrin (i-PRF) on wound healing at the donor site following free gingival graft (FGG) procedures. The palatal donor area often experiences delayed healing and postoperative discomfort, motivating the search for effective biomaterials to enhance recovery and reduce patient morbidity. Although various approaches have been investigated, the combined application of chitosan and i-PRF has not yet been explored in this context.
The study examines three patient groups treated at the periodontology departments of Çukurova and Biruni University: one with gelatin sponge (control), one with chitosan, and one with chitosan infused with i-PRF. Parameters such as pain (VAS), bleeding, burning sensation, dietary changes, epithelialization (PEHI score), and color match were assessed over a 2-month follow-up.
The findings are expected to provide insights into whether i-PRF-enhanced chitosan offers superior healing outcomes and greater patient comfort compared to conventional methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Other | Procedure: free gingival graft + gelatin spongecontrol group |
| chitosan | Active comparator | Procedure: free gingival graft + chitosan |
| chitosan-iprf | Experimental | Procedure: free gingival graft + chitosan and i-PRF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Periodontally healthy
- Having good oral hygiene (plaque accumulation <20%)
- Requiring a free gingival graft (FGG) procedure in an area with insufficient keratinized gingiva width (<2 mm)
Key exclusion criteria (6 listed)
- Having systemic diseases contraindicating surgical procedures,
- Uncontrolled diabetes (HbA1c > 7),
- Being pregnant or breastfeeding,
- Autoimmune and/or inflammatory diseases of the oral cavity,
- Active periodontal disease,
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 graft + gelatin spongeFree gingival graft surgery and application of gelatin sponge to the palatal wound | Procedure or surgery | control |
| free gingival graft + chitosanfree gingival graft surgery and application of chitosan to the palatal wound | Procedure or surgery | chitosan |
| free gingival graft + chitosan and i-PRFfree gingival graft surgery and application of chitosan and i-PRF to the palatal wound | Procedure or surgery | chitosan-iprf |
Primary outcome
Palatal early healing index
Time frame: Day 7
The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).
Palatal early healing index
Time frame: Day 14
The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).
Palatal early healing index
Time frame: Day 28
The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).
Palatal early healing index
Time frame: Day 56
The palatal early healing index (PEHI) measured the following 5 parameters: (1) bleeding on palpation, which was assessed with a damp cotton applicator gently rolled on the wound site; (2) incomplete epithelialization (assessed intraorally by the visual presence or absence of immediate bubble formation after hydrogen peroxide application with sterile gauze on the wound area); (3) presence of redness assessed intraorally; (4) presence of swelling assessed intraorally; and (5) presence of granulation tissue assessed intraorally. Each of the 5 parameters was assessed dichotomously (yes/no).
33 secondary outcomes
Palatal Pain score
Time frame: Day 1
Palatal Pain score
Time frame: Day 3
Palatal Pain score
Time frame: Day 7
Palatal Pain score
Time frame: Day 14
Palatal Pain score
Time frame: Day 28
Palatal Pain score
Time frame: Day 56
Use of analgesics and palatal bleeding
Time frame: Day 1
Difficulty in chewing
Time frame: Day 7
Difficulty in chewing
Time frame: Day 14
Difficulty in chewing
Time frame: Day 28
Difficulty in chewing
Time frame: Day 56
Use of analgesics and palatal bleeding
Time frame: Day 2
Use of analgesics and palatal bleeding
Time frame: Day 3
Use of analgesics and palatal bleeding
Time frame: Day 4
Use of analgesics and palatal bleeding
Time frame: Day 5
Use of analgesics and palatal bleeding
Time frame: Day 6
Use of analgesics and palatal bleeding
Time frame: Day 7
Graft dimentions
Time frame: Day 0
Color match
Time frame: Day 14
Color match
Time frame: Day 28
Color match
Time frame: Day 56
Burning sensation
Time frame: Day 1
Burning sensation
Time frame: Day 3
Burning sensation
Time frame: Day 7
Burning sensation
Time frame: Day 14
Burning sensation
Time frame: Day 28
Burning sensation
Time frame: Day 56
Changes in dietary habits
Time frame: Day 1
Changes in dietary habits
Time frame: Day 3
Changes in dietary habits
Time frame: Day 7
Changes in dietary habits
Time frame: Day 14
Changes in dietary habits
Time frame: Day 28
Changes in dietary habits
Time frame: Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 + gelatin sponge, free gingival graft + chitosan and free gingival graft + chitosan and i-PRF in people with Free Gingival Graft and Wound Healing, run by Biruni University at 2 sites 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 3 inclusion and 6 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Palatal early healing index (time frame: Day 7). The study lists 4 primary outcomes in all. 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 27 Jan 2026.