Wound HealingNCT06459947
Effect of Cyanoacrylate and Concentrated Growth Factor on Palatal Donor Site
A study testing Free gingival graft procedure in people with Wound Healing and Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after free gingival graft (FGG) operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and concentrated growth factor (CGF) applications. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing, Pain, Patient Comfort
- What is being tested?
- Free gingival graft procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2024to 28 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy
- not had periodontal surgery in the last 6 months
Who cannot join
- smoker
- allergic to medication
- high anxiety (using modified dental anxiety scale)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cyanoacrylate and Concentrated Growth Factor on Wound Healing and Patient Comfort at the Palatal Donor Site
The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after free gingival graft (FGG) operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and concentrated growth factor (CGF) applications.
Read the detailed description
Free gingival graft obtained in the palatal region causes morbidity. Therefore, clinicians try to overcome these difficulties by isolating the wound in the palatal region from the oral environment and/or accelerating wound healing.
Periodontal dressings, acrylic stents, hemostatic agents, surgical sponges, platelet concentrates, low-level laser therapy, photobiomodulation, cyanoacrylate tissue adhesives and hyaluronic acid are some of the methods used for donor site management or to accelerate healing.
Cyanoacrylate adhesives form an adhesive film through rapid polymerization triggered by the hydroxyl groups on the surfaces to which they are applied. They have both bacteriostatic and hemostatic properties.
In recent years, it has been observed that the use of platelet concentrates such as Platelet Rich Plasma (PRP), Platelet Rich Fibrin (PRF) and autogenous products such as CGF (concentrated growth factor) in periodontal treatments has increased.
CGF is obtained by centrifuging blood in four different cycles and times. This product contains a relatively intact fibrin clot containing platelets, leukocytes, various growth factors and cytokines. CGF can be applied as a carrier of growth factors and/or a barrier membrane to aid tissue regeneration and wound healing in clinical applications.
The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after FGG operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and CGF applications.
- Conditions
- Wound Healing, Pain, Patient Comfort
- Being tested
- Free gingival graft procedure
- Keywords
- cyanoacrylate, free gingival graft, concentrated growth factor
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graft procedureProcedure or surgery
The palatal area is anesthetized using local anesthesia. The free gingival graft (FGG) is taken from the donor site with a scalpel.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group) | Active comparator | After FGG is taken from the palatal area, the sponge is placed in the wound area. Receives: Procedure: Free gingival graft procedure |
| Group 2 (Cyanoacrylate group) | Active comparator | After the FGG is taken from the palatal area, a cyanoacrylate tissue adhesive is placed in the wound area. Receives: Procedure: Free gingival graft procedure |
| Group 3 (Concentrated Growth Factor group) | Active comparator | After the FGG is taken from the palatal area, concentrated growth factor (CGF) group is placed in the wound area. CGF is obtained by centrifuging blood in four different cycles and times. Receives: Procedure: Free gingival graft procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
The patient is given a form to record the post-operative pain level in the palatial area with Visual analogue scale (VAS). The VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain)
Measured: The pain level is recorded every hour for the first 8 hours after the operation, and on the 2nd, 3rd, 4th, 5th, 6th, 7th days after the operation.
Epithelialization
Hydrogen peroxide is used to detect epithelialization in the donor area after the operation. If epithelialization is not completed, H2O2 affects the catalase enzyme in the connective tissue and releases water and oxygen. Thus, clinically, it forms blisters on the palatal wound surface. Epithelialization scores will be divided into three groups: absent, partially epitheliazed and completely epithelialized.
Measured: The epithelialization is examined on the 7th, 14th, 21st, and 28th days
Secondary outcomes (4)
Number of analgesic drugs
Patients are asked to note the number of analgesics they took for pain during the first week.
Measured: Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Healing Index
The Healing Index is recorded with a 5-level score ranging from 1 (very poor) to 5 (excellent).
Measured: The Healing Index is recorded on the 7th, 14th, 21st and 28th days.
Color Match
The color match is evaluated by Visual analogue scale (VAS). (0: no color match, 10: perfect color match)
Measured: The color match is evaluated on the 7th, 14th, 21st and 28th days.
Secondary Bleeding
Post-operative bleeding in the palatal region is noted. The patient notes the postoperative bleeding status of the palatal area. Bleeding scores are recorded as yes or no.
Measured: Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start2 Mar 2024
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dicle Altındal, Yuzuncu Yil University
- Investigators
- Dicle Altindal, DDS, Principal investigator, Yuzuncu Yil UniversityElif Tore Sari, PhD, Study chair, Yuzuncu Yil UniversityNazli Zeynep Alpaslan, PhD, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459947
- Sponsor's protocol ID
- 28.02.2024/07
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lektemur Alpan A, Torumtay Cin G. PRF improves wound healing and postoperative discomfort after harvesting subepithelial connective tissue graft from palate: a randomized controlled trial. Clin Oral Investig. 2020 Jan;24(1):425-436. doi: 10.1007/s00784-019-02934-9. Epub 2019 May 18.
PubMed 31104113Verissimo AH, Ribeiro AKC, Martins ARLA, Gurgel BCV, Lins RDAU. Comparative analysis of the hemostatic, analgesic and healing effects of cyanoacrylate on free gingival graft surgical wounds in donor and recipient areas: a systematic review. J Mater Sci Mater Med. 2021 Aug 18;32(9):98. doi: 10.1007/s10856-021-06573-z.
PubMed 34406492Altindal D, Sari Can ET, Alpaslan NZ. The effects of cyanoacrylate and concentrated growth factor on wound healing and patient comfort at the palatal donor site: a randomized controlled clinical trial. Clin Oral Investig. 2026 Sep 7;30(10):434. doi: 10.1007/s00784-026-07113-1.
PubMed 42702656
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cyanoacrylate and Concentrated Growth Factor on Wound Healing and Patient Comfort at the Palatal Donor Site
- ClinicalTrials.gov ID
- NCT06459947
- Acronym / sponsor ID
- 28.02.2024/07
- Conditions
- Wound Healing, Pain, Patient Comfort
- Keywords
- cyanoacrylate, free gingival graft, concentrated growth factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 14 Jun 2024 (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 aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after free gingival graft (FGG) operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and concentrated growth factor (CGF) applications.
Detailed description
Free gingival graft obtained in the palatal region causes morbidity. Therefore, clinicians try to overcome these difficulties by isolating the wound in the palatal region from the oral environment and/or accelerating wound healing.
Periodontal dressings, acrylic stents, hemostatic agents, surgical sponges, platelet concentrates, low-level laser therapy, photobiomodulation, cyanoacrylate tissue adhesives and hyaluronic acid are some of the methods used for donor site management or to accelerate healing.
Cyanoacrylate adhesives form an adhesive film through rapid polymerization triggered by the hydroxyl groups on the surfaces to which they are applied. They have both bacteriostatic and hemostatic properties.
In recent years, it has been observed that the use of platelet concentrates such as Platelet Rich Plasma (PRP), Platelet Rich Fibrin (PRF) and autogenous products such as CGF (concentrated growth factor) in periodontal treatments has increased.
CGF is obtained by centrifuging blood in four different cycles and times. This product contains a relatively intact fibrin clot containing platelets, leukocytes, various growth factors and cytokines. CGF can be applied as a carrier of growth factors and/or a barrier membrane to aid tissue regeneration and wound healing in clinical applications.
The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after FGG operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and CGF applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control group) | Active comparator | Procedure: Free gingival graft procedureAfter FGG is taken from the palatal area, the sponge is placed in the wound area. |
| Group 2 (Cyanoacrylate group) | Active comparator | Procedure: Free gingival graft procedureAfter the FGG is taken from the palatal area, a cyanoacrylate tissue adhesive is placed in the wound area. |
| Group 3 (Concentrated Growth Factor group) | Active comparator | Procedure: Free gingival graft procedureAfter the FGG is taken from the palatal area, concentrated growth factor (CGF) group is placed in the wound area. CGF is obtained by centrifuging blood in four different cycles and times. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- systemically healthy
- not had periodontal surgery in the last 6 months
Key exclusion criteria (3 listed)
- smoker
- allergic to medication
- high anxiety (using modified dental anxiety scale)
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 procedureThe palatal area is anesthetized using local anesthesia. The free gingival graft (FGG) is taken from the donor site with a scalpel. | Procedure or surgery | Group 1 (Control group), Group 2 (Cyanoacrylate group), Group 3 (Concentrated Growth Factor group) |
Primary outcome
VAS
Time frame: The pain level is recorded every hour for the first 8 hours after the operation, and on the 2nd, 3rd, 4th, 5th, 6th, 7th days after the operation.
The patient is given a form to record the post-operative pain level in the palatial area with Visual analogue scale (VAS). The VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain)
Epithelialization
Time frame: The epithelialization is examined on the 7th, 14th, 21st, and 28th days
Hydrogen peroxide is used to detect epithelialization in the donor area after the operation. If epithelialization is not completed, H2O2 affects the catalase enzyme in the connective tissue and releases water and oxygen. Thus, clinically, it forms blisters on the palatal wound surface. Epithelialization scores will be divided into three groups: absent, partially epitheliazed and completely epithelialized.
4 secondary outcomes
Number of analgesic drugs
Time frame: Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Healing Index
Time frame: The Healing Index is recorded on the 7th, 14th, 21st and 28th days.
Color Match
Time frame: The color match is evaluated on the 7th, 14th, 21st and 28th days.
Secondary Bleeding
Time frame: Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
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 17 Jun 2026.
- Background: PubMed 31104113Lektemur Alpan A, Torumtay Cin G. PRF improves wound healing and postoperative discomfort after harvesting subepithelial connective tissue graft from palate: a randomized controlled trial. Clin Oral Investig. 2020 Jan;24(1):425-436. doi: 10.1007/s00784-019-02934-9. Epub 2019 May 18.
- Background: PubMed 34406492Verissimo AH, Ribeiro AKC, Martins ARLA, Gurgel BCV, Lins RDAU. Comparative analysis of the hemostatic, analgesic and healing effects of cyanoacrylate on free gingival graft surgical wounds in donor and recipient areas: a systematic review. J Mater Sci Mater Med. 2021 Aug 18;32(9):98. doi: 10.1007/s10856-021-06573-z.
- Derived from this study: PubMed 42702656Altindal D, Sari Can ET, Alpaslan NZ. The effects of cyanoacrylate and concentrated growth factor on wound healing and patient comfort at the palatal donor site: a randomized controlled clinical trial. Clin Oral Investig. 2026 Sep 7;30(10):434. doi: 10.1007/s00784-026-07113-1.
- Individual participant dataSharing planned: No
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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.
Dicle Altindal, DDS principal investigator
Yuzuncu Yil University
Elif Tore Sari, PhD study chair
Yuzuncu Yil University
Nazli Zeynep Alpaslan, PhD study chair
Yuzuncu Yil University
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 procedure in people with Wound Healing and Pain, run by Yuzuncu Yil University 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 2 inclusion and 3 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 17 Jun 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?
VAS (time frame: The pain level is recorded every hour for the first 8 hours after the operation, and on the 2nd, 3rd, 4th, 5th, 6th, 7th days after the operation.). The study lists 2 primary outcomes in all. 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 NCT06459947, which also lists 3 linked publications.
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 17 Jun 2026.