Wound HealingNCT06950359
Comparing Two Wound Coverings for Healing and Comfort After Palatal Gum Graft Surgery in Adults
A study testing Gelatin Sponge Dressing (Cutanplast®), Cyanoacrylate Tissue Adhesive (PeriAcryl®) and Polyglycolic Acid Sheet (Neoveil®) in people with Wound Healing, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
After gum-grafting surgery, the bare spot in the palate can be slow to heal and quite sore. In this study, the investigators are trying three dressing methods to see which helps most: Standard care: gelatin sponge alone, Option A: gelatin sponge plus quick-dry tissue glue (cyanoacrylate), Option B: gelatin sponge plus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing
- What is being tested?
- Gelatin Sponge Dressing (Cutanplast®), Cyanoacrylate Tissue Adhesive (PeriAcryl®) and Polyglycolic Acid Sheet (Neoveil®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2024to 14 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Good oral hygiene
- Not using any medications that affect wound healing
- No systemic diseases that may impair the normal healing process
- Non-smokers
- No clotting disorders
- Not being pregnant or in the lactation period (for female patients)
Who cannot join
- Patients with systemic conditions (e.g., diabetes, radiotherapy/chemotherapy, etc.)
- Individuals using any medication that may affect wound healing
- Individuals with coagulation disorders
- Smokers
- Pregnancy and breastfeeding
- Poor oral hygiene
- Patients who do not attend follow-up appointments regularly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs Üniversitesi Diş Hekimliği Fakültesi - Ondokuz Mayis University Faculty of Dentistry
Samsun, Samsun, 55270
About this study
Official title: Evaluation of the Effects of Cyanoacrylate and Polyglycolic Acid-Based Wound Dressings on Secondary Wound Healing
After gum-grafting surgery, the bare spot in the palate can be slow to heal and quite sore. In this study, the investigators are trying three dressing methods to see which helps most: Standard care: gelatin sponge alone, Option A: gelatin sponge plus quick-dry tissue glue (cyanoacrylate), Option B: gelatin sponge plus a dissolvable mesh (polyglycolic acid). Investigators will enroll 45 adults having a free gingival graft and randomly assign 15 people to each group. Once the graft is taken, investigators will apply and suture in the assigned dressing. Follow-up visits will occur at 1 and 2 weeks, and at 1 and 2 months. Investigators will evaluate: Wound healing using two simple scales-how fast the site repairs (LTH index) and (MMS). Pain and burning sensations will also be recorded using a visual analog scale (VAS). By comparing these three approaches, investigators hope to find which dressing speeds recovery, improves the final result, and keeps discomfort to a minimum.
Read the detailed description
Free gingival grafting (FGG) is a well-established periodontal procedure commonly used to increase keratinized tissue width or treat gingival recessions. However, harvesting tissue from the palate leaves a secondary wound at the donor site, which often heals by secondary intention. This can result in considerable postoperative discomfort, delayed epithelialization, and an increased risk of complications such as bleeding, infection, or scarring. This randomized, controlled clinical trial aims to compare the effectiveness of three different wound dressing approaches in promoting healing and reducing patient morbidity at the palatal donor site following FGG surgery. A total of 45 adult patients requiring FGG for periodontal or mucogingival indications will be enrolled and randomly assigned (1:1:1 ratio) into three groups: Control Group: Gelatin sponge (standard care), CYA Group (Option A): Gelatin sponge combined with a cyanoacrylate tissue adhesive (a fast-polymerizing topical glue) and PGA Group (Option B): Gelatin sponge combined with a bioresorbable polyglycolic acid (PGA) sheet. All materials used are biocompatible and approved for surgical application. After the graft is harvested, the assigned dressing will be sutured to the palatal wound under standard aseptic conditions. No additional protective stent will be used to isolate the effect of the test materials. The study is designed to evaluate and compare outcomes related to tissue healing, patient-reported pain, and wound appearance over a structured postoperative timeline. Patients will be followed up on Day 7, Day 14, and at 1 and 2 months after surgery. Objective Clinical Assessments include: Wound healing: Assessed via the Landry, Turnbull, and Howley (LTH) Index and Modified Manchester Scar Scale (MMS), Epithelialization: Measured using the hydrogen peroxide (H₂O₂) bubble test, a visual indicator of open vs. epithelialized tissue. Subjective Patient-Reported Outcomes: Pain and burning sensation: Recorded using a 0-100 Visual Analog Scale (VAS) during the first 7 postoperative days and at follow-up visits. This trial will explore whether the addition of cyanoacrylate or PGA dressing materials can improve clinical healing parameters and enhance patient comfort compared to standard gelatin sponge treatment. The hypothesis is that bioactive dressings may promote faster epithelialization and superior healing outcomes, while also minimizing early postoperative pain. The findings from this trial may contribute to developing best-practice protocols for donor site management following periodontal soft tissue grafting, with the potential to enhance recovery quality and patient satisfaction.
- Conditions
- Wound Healing
- Being tested
- Gelatin Sponge Dressing (Cutanplast®), Cyanoacrylate Tissue Adhesive (PeriAcryl®), Polyglycolic Acid Sheet (Neoveil®)
- Keywords
- Secondary wound healing, Periodontal surgery, Palatal wound healing, Cyanoacrylate tissue adhesive, Polyglycolic acid dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin Sponge Dressing (Cutanplast®)Device
Absorbable gelatin-based hemostatic sponge used for all study groups as a wound contact dressing.
Cyanoacrylate Tissue Adhesive (PeriAcryl®)Device
High-viscosity N-Butyl Cyanoacrylate/2-Octyl Cyanoacrylate adhesive applied as a topical barrier to the palatal wound site in the Cyanoacrylate Group.
Polyglycolic Acid Sheet (Neoveil®)Device
Bioresorbable PGA sheet placed over the gelatin sponge in the Polyglycolic Acid Group to enhance wound protection and healing.
| Study group | Role | What they receive |
|---|---|---|
| Gelatin Sponge (Control Group) | Active comparator | Participants (n=15) received a gelatin sponge dressing (Cutanplast®) placed over the palatal donor site and secured with crossed sling sutures around adjacent teeth. Receives: Device: Gelatin Sponge Dressing (Cutanplast®) |
| Cyanoacrylate Group (Test Group 1) | Experimental | Participants (n=15) received a gelatin sponge dressing (Cutanplast®), followed by application of cyanoacrylate tissue adhesive (PeriAcryl®) to the sponge and wound margins. The dressing was stabilized using crossed sling sutures. Receives: Device: Gelatin Sponge Dressing (Cutanplast®); Device: Cyanoacrylate Tissue Adhesive (PeriAcryl®) |
| Polyglycolic Acid Group (Test Group 2) | Experimental | Participants (n=15) received a gelatin sponge dressing (Cutanplast®) covered with a polyglycolic acid sheet (Neoveil®), trimmed to fit the wound and fixed with crossed sling sutures. Receives: Device: Gelatin Sponge Dressing (Cutanplast®); Device: Polyglycolic Acid Sheet (Neoveil®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMS (Modified Manchester Scar Scale)
Healing quality assessed by scoring color, contour, and distortion. Each category: 0 (best) to 2 (worst). Total score: 0 (best) to 6 (worst).
Scale Range: 0-6 Directionality: Lower scores = better outcome
Measured: Post-operative days 7, 14, and 1st month
Landry, Turnbull and Howley (LTH) healing index
Healing quality scored from 1 (very poor) to 5 (excellent) based on redness, bleeding, granulation, epithelialization, and suppuration.
Scale Range: 1-5 Directionality: Higher scores = better outcome
Measured: Post-operative day 7, day 14, 1st month and 2nd month
Epithelialization (H₂O₂ bubbling test)
Complete epithelialization assessed using 3% hydrogen peroxide. Positive (bubbles present) = no epithelialization Negative (no bubbles) = complete epithelialization Scale Type: Binary (Positive/Negative) Directionality: Negative result = better outcome
Measured: Post-operative day 7, day 14 and 1st month
VAS pain score
Assessed using a 0-100 modified Visual Analog Scale (VAS), where 0 = no pain and 100 = worst imaginable pain. Patients recorded pain levels daily for 7 days. Additional follow-ups occurred on Day 14, and Month 1.
Scale Range: 0-100 Directionality: Higher scores = worse outcome
Measured: Post-operative days 1-7, 14th day and 1st month
Secondary outcomes (1)
VAS burning sensation score
Assessed using a 0-100 modifed Visual Analog Scale (VAS), where 0 = no burning sensation and 100 = worst imaginable burning sensation. Patients recorded burning sensation levels daily for 7 days. Additional follow-ups occurred on Day 14, and Month 1. Scale Range: 0-100 Directionality: Higher scores = worse outcome
Measured: Post-operative days 1-7, 14th day and 1st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start7 Jan 2024
- Primary completion14 Dec 2024
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hooman Hashemzadeh, Ondokuz Mayıs University
- Investigators
- Hooman Hashemzadeh, DDS, Principal investigator, Ondokuz Mayıs UniversityUmur Sakallıoğlu, PHD, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950359
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/712
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Cyanoacrylate and Polyglycolic Acid-Based Wound Dressings on Secondary Wound Healing
- ClinicalTrials.gov ID
- NCT06950359
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/712
- Conditions
- Wound Healing
- Keywords
- Secondary wound healing, Periodontal surgery, Palatal wound healing, Cyanoacrylate tissue adhesive, Polyglycolic acid dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 30 Apr 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.
After gum-grafting surgery, the bare spot in the palate can be slow to heal and quite sore. In this study, the investigators are trying three dressing methods to see which helps most: Standard care: gelatin sponge alone, Option A: gelatin sponge plus quick-dry tissue glue (cyanoacrylate), Option B: gelatin sponge plus a dissolvable mesh (polyglycolic acid). Investigators will enroll 45 adults having a free gingival graft and randomly assign 15 people to each group. Once the graft is taken, investigators will apply and suture in the assigned dressing. Follow-up visits will occur at 1 and 2 weeks, and at 1 and 2 months. Investigators will evaluate: Wound healing using two simple scales-how fast the site repairs (LTH index) and (MMS). Pain and burning sensations will also be recorded using a visual analog scale (VAS). By comparing these three approaches, investigators hope to find which dressing speeds recovery, improves the final result, and keeps discomfort to a minimum.
Detailed description
Free gingival grafting (FGG) is a well-established periodontal procedure commonly used to increase keratinized tissue width or treat gingival recessions. However, harvesting tissue from the palate leaves a secondary wound at the donor site, which often heals by secondary intention. This can result in considerable postoperative discomfort, delayed epithelialization, and an increased risk of complications such as bleeding, infection, or scarring. This randomized, controlled clinical trial aims to compare the effectiveness of three different wound dressing approaches in promoting healing and reducing patient morbidity at the palatal donor site following FGG surgery. A total of 45 adult patients requiring FGG for periodontal or mucogingival indications will be enrolled and randomly assigned (1:1:1 ratio) into three groups: Control Group: Gelatin sponge (standard care), CYA Group (Option A): Gelatin sponge combined with a cyanoacrylate tissue adhesive (a fast-polymerizing topical glue) and PGA Group (Option B): Gelatin sponge combined with a bioresorbable polyglycolic acid (PGA) sheet. All materials used are biocompatible and approved for surgical application. After the graft is harvested, the assigned dressing will be sutured to the palatal wound under standard aseptic conditions. No additional protective stent will be used to isolate the effect of the test materials. The study is designed to evaluate and compare outcomes related to tissue healing, patient-reported pain, and wound appearance over a structured postoperative timeline. Patients will be followed up on Day 7, Day 14, and at 1 and 2 months after surgery. Objective Clinical Assessments include: Wound healing: Assessed via the Landry, Turnbull, and Howley (LTH) Index and Modified Manchester Scar Scale (MMS), Epithelialization: Measured using the hydrogen peroxide (H₂O₂) bubble test, a visual indicator of open vs. epithelialized tissue. Subjective Patient-Reported Outcomes: Pain and burning sensation: Recorded using a 0-100 Visual Analog Scale (VAS) during the first 7 postoperative days and at follow-up visits. This trial will explore whether the addition of cyanoacrylate or PGA dressing materials can improve clinical healing parameters and enhance patient comfort compared to standard gelatin sponge treatment. The hypothesis is that bioactive dressings may promote faster epithelialization and superior healing outcomes, while also minimizing early postoperative pain. The findings from this trial may contribute to developing best-practice protocols for donor site management following periodontal soft tissue grafting, with the potential to enhance recovery quality and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gelatin Sponge (Control Group) | Active comparator | Device: Gelatin Sponge Dressing (Cutanplast®)Participants (n=15) received a gelatin sponge dressing (Cutanplast®) placed over the palatal donor site and secured with crossed sling sutures around adjacent teeth. |
| Cyanoacrylate Group (Test Group 1) | Experimental | Device: Gelatin Sponge Dressing (Cutanplast®), Device: Cyanoacrylate Tissue Adhesive (PeriAcryl®)Participants (n=15) received a gelatin sponge dressing (Cutanplast®), followed by application of cyanoacrylate tissue adhesive (PeriAcryl®) to the sponge and wound margins. The dressing was stabilized using crossed sling sutures. |
| Polyglycolic Acid Group (Test Group 2) | Experimental | Device: Gelatin Sponge Dressing (Cutanplast®), Device: Polyglycolic Acid Sheet (Neoveil®)Participants (n=15) received a gelatin sponge dressing (Cutanplast®) covered with a polyglycolic acid sheet (Neoveil®), trimmed to fit the wound and fixed with crossed sling sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years and older
- Good oral hygiene
- Not using any medications that affect wound healing
- No systemic diseases that may impair the normal healing process
- Non-smokers
Key exclusion criteria (7 listed)
- Patients with systemic conditions (e.g., diabetes, radiotherapy/chemotherapy, etc.)
- Individuals using any medication that may affect wound healing
- Individuals with coagulation disorders
- Smokers
- Pregnancy and breastfeeding
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 |
|---|---|---|
| Gelatin Sponge Dressing (Cutanplast®)Absorbable gelatin-based hemostatic sponge used for all study groups as a wound contact dressing. | Device | Cyanoacrylate Group (Test Group 1), Gelatin Sponge (Control Group), Polyglycolic Acid Group (Test Group 2) |
| Cyanoacrylate Tissue Adhesive (PeriAcryl®)High-viscosity N-Butyl Cyanoacrylate/2-Octyl Cyanoacrylate adhesive applied as a topical barrier to the palatal wound site in the Cyanoacrylate Group. | Device | Cyanoacrylate Group (Test Group 1) |
| Polyglycolic Acid Sheet (Neoveil®)Bioresorbable PGA sheet placed over the gelatin sponge in the Polyglycolic Acid Group to enhance wound protection and healing. | Device | Polyglycolic Acid Group (Test Group 2) |
Primary outcome
MMS (Modified Manchester Scar Scale)
Time frame: Post-operative days 7, 14, and 1st month
Healing quality assessed by scoring color, contour, and distortion. Each category: 0 (best) to 2 (worst). Total score: 0 (best) to 6 (worst). Scale Range: 0-6 Directionality: Lower scores = better outcome
Landry, Turnbull and Howley (LTH) healing index
Time frame: Post-operative day 7, day 14, 1st month and 2nd month
Healing quality scored from 1 (very poor) to 5 (excellent) based on redness, bleeding, granulation, epithelialization, and suppuration. Scale Range: 1-5 Directionality: Higher scores = better outcome
Epithelialization (H₂O₂ bubbling test)
Time frame: Post-operative day 7, day 14 and 1st month
Complete epithelialization assessed using 3% hydrogen peroxide. Positive (bubbles present) = no epithelialization Negative (no bubbles) = complete epithelialization Scale Type: Binary (Positive/Negative) Directionality: Negative result = better outcome
VAS pain score
Time frame: Post-operative days 1-7, 14th day and 1st month
Assessed using a 0-100 modified Visual Analog Scale (VAS), where 0 = no pain and 100 = worst imaginable pain. Patients recorded pain levels daily for 7 days. Additional follow-ups occurred on Day 14, and Month 1. Scale Range: 0-100 Directionality: Higher scores = worse outcome
1 secondary outcome
VAS burning sensation score
Time frame: Post-operative days 1-7, 14th day and 1st month
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 30 Apr 2025.
- 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.
Hooman Hashemzadeh, DDS principal investigator
Ondokuz Mayıs University
Umur Sakallıoğlu, PHD study director
Ondokuz Mayıs 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 Gelatin Sponge Dressing (Cutanplast®), Cyanoacrylate Tissue Adhesive (PeriAcryl®) and Polyglycolic Acid Sheet (Neoveil®) in people with Wound Healing, run by Ondokuz Mayıs 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 7 inclusion and 7 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 30 Apr 2025. 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?
MMS (Modified Manchester Scar Scale) (time frame: Post-operative days 7, 14, and 1st month). 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 30 Apr 2025.