Palate; WoundEarly Phase 1RCTNCT07086482
Effect of Cyanoacrylate Tissue Adhesive Versus Collagen Sponge on Palatal Donor Site Healing
A Early Phase 1 study testing Cyanoacrylate tissue adhesive and Collagen sponge in people with Palate; Wound, run by Beirut Arab University at 1 site in Lebanon.
Trial summary
The goal of this clinical trial is to learn if the use of cyanoacrylate glue (PeriAcryl) is effective in healing of the palatal donor site in adults requiring a free gingival graft. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palate; Wound
- What is being tested?
- Cyanoacrylate tissue adhesive and Collagen sponge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteLebanon
- Study dates
- 4 Aug 2025to 20 Apr 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low-moderate anesthetic risk (ASA I-II)
- No restriction on ethnicity or gender
- Patients requiring FGG from the palate for periodontal plastic surgery
- Clinically healthy gingiva after phase I therapy
- Full-mouth plaque index grades 0 and 1
- Bleeding scores <15%
Who cannot join
- Patients who smoke > 10 cigarettes/day
- Patients with coagulation disorders
- Systemic diseases
- Patients on certain medications that may affect periodontal tissues
- Pregnant and lactating patient
- Patients with allergies to drugs that will be prescribed during the treatment phase
- Pathological mental conditions (dementia, psychosis) and lack of cooperation
- Excessive gag reflex
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
Beirut Arab University
Beirut
Nayer Aboelsaad, +96179109899, n.mohamedaboelsaad@bau.edu.lb
About this study
Official title: Effect of Cyanoacrylate Tissue Adhesive Versus Collagen Sponge on Palatal Donor Site Healing After Harvesting a Free Gingival Graft: a Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn if the use of cyanoacrylate glue (PeriAcryl) is effective in healing of the palatal donor site in adults requiring a free gingival graft.
The main question[s] it aims to answer [is/are]:
Read more
Does PeriAcryl accelerate the palatal tissue healing compared with the use of collagen sponge? Does PeriAcryl usage leave the patients more satisfied?
Researcher will compare the outcomes of participants treated with PeriAcryl to those treated with collagen sponge to see if PeriAcryl accelerated the healing process of palatal tissues and led to fewer postoperative complications.
Participants will:
- be assigned to a study group using PeriAcryl or control group using Collagen sponge.
- be followed-up to monitor healing and gather clinical information.
Read the detailed description
This study investigates new approaches to make management of the palatal donor area easier to the operator and more comfortable to the patient. More specifically, it compares the use of PeriAcryl glue (PA) to the use of collagen sponge after harvesting a free gingival graft from the palate in terms of wound healing and epithelization primarily, and patients satisfaction and oral health related quality of life secondarily.
Participants selection:
Healthy patients (with no systemic diseases or coagulation disorders) requiring a free gingival graft to treat a gingival recession or keratinized tissue deficiency around implants and natural teeth will be recruited.
Participants included in this study must have clinically healthy gingiva and good oral hygiene.
Participants grouping:
- Control group: Hemostasis will be achieved by collagen sponge stabilized with 4/0 silk (x) suture on the palatal wound.
- Test group: Cyanoacrylate tissue adhesive (Periacryl®, GluStitch Inc., Canada) will be applied with a pipette following manufacturer's instructions on the entire area of the wound.
All the procedures will be achieved with the full knowledge and consent of the patient. A written informed consent will be obtained for each patient included in this study.
Surgical Protocol:
- Full mouth scaling will be done for every patient at least 2 weeks before the surgery.
- The donor area will be anesthetized using articaine 4% with epinephrine 1:100,000.
- Palatal tissue thickness will be measured using a periodontal probe. Then a free gingival graft (FGG) will be harvested using a 15c blade of 1 to 1.5 mm in thickness, approximately 3 mm away from the palatal gingival margin.
- Pressure will be applied to the donor surface using gauze soaked in saline solution to stop bleeding, while the FGG will be prepared, stabilized and sutured at the recipient site.
- The operator will then receive a sealed envelope holding each patient's assigned grouping as soon as the graft extraction process is finished.
Post-operative Care:
All patients will get the same prescription of antibiotics (Amoxiclave 1g) twice daily for 7 days, and Ibuprofen 600 mg every 8 hours only taken when needed. As well as chlorohexidine 0.12% mouthwash twice daily for 2 weeks.
The same instructions will be given to all the patients (cease smoking, soft diet, oral hygiene, not brushing hard and causing trauma to the surgical site...).
The test group participants receiving PA in the palatal donor will be informed about the material and that it will disintegrate on its own after 10 days.
While the control group participants receiving collagen sponge with (x) sutures in the palatal donor will be informed that the sutures will be removed after 2 weeks.
Following the operation, a questionnaire will be given to each patient asking them to record any spontaneous bleeding of the surgical incision during the first seven days following the procedure, as well as to rate their level of postoperative discomfort using a visual analogue scale (VAS), quantity of analgesics taken, and other questions related to quality of life.
Follow-ups:
All patients will be followed-up at 7, 14, 21 days, 1 month, 2 months, and 3 months, to evaluate healing up to the formation of the first epithelial layer as evaluated by pressure with a periodontal probe and Laundry wound healing index, and the time of complete integrity of the treated palatal fibromucosa.
- Conditions
- Palate; Wound
- Being tested
- Cyanoacrylate tissue adhesive, Collagen sponge
- Keywords
- palatal donor area, Cyanoacrylate glue, wound healing, free gingival graft
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate tissue adhesiveCombination product
Also called PeriAcryl
Cyanoacrylate tissue adhesive is a chemical synthetic and hybrid tissue sealant possessing strong, rapid acting adhesive properties and is often used in general surgery. Recently, cyanoacrylate tissue adhesive has been effectively introduced into dentistry to close wounds and stop ischemic areas from forming in periodontal aesthetic surgeries. As well as in exposed membranes to preserve the bone graft after guided bone regeneration, in post-extraction sockets, and to seal any surgical flap. This material has strong hemostatic, bacteriostatic, and sealing qualities.
Collagen spongeDevice
Collagen sponge is an organic polymer that promotes the development of blood clots, and it resorbs quickly and completely over time. Collagen sponge create a matrix at the bleeding site, encourage platelet activation and aggregation, and engage the extrinsic coagulation pathway. Thus, it can be utilized as the first choice for wound healing.
| Study group | Role | What they receive |
|---|---|---|
| Collagen sponge | Active comparator | Participants will be treated with collagen sponge at the palatal donor wound to achieve hemostasis. After FGG harvest, pressure will be applied at the palatal wound using a gauze soaked in saline to top the bleeding, then a collagen sponge will be placed and stabilized with 4/0 silk (x) sutures. Receives: Device: Collagen sponge |
| Cyanoacrylate tissue adhesive | Experimental | Participants will be treated with cyanoacrylate tissue adhesive (PeriAcryl) at the palatal donor wound to achieve hemostasis. After FGG harvest, pressure will be applied at the palatal wound using a gauze soaked in saline to top the bleeding, then PeriAcryl will be applied with a pipette following manufacturer's instructions on the entire area of the wound. Receives: Combination Product: Cyanoacrylate tissue adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of palatal wound
Healing will be evaluated using Laundry Wound Healing Index (WHI). WHI has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins, and amount of suppuration.
Measured: 1 month, 2 months and 3 months post-operatively.
Epithelization of the palatal wound
The complete epithelialization will be evaluated clinically by applying 3% hydrogen peroxide into the palatal wound. If bubble formation is not observed, epithelization will be recorded as complete, whereas if bubbles are observed, epithelization will be recorded as incomplete.
Measured: On every follow-up session: 7 days, 14 days, 21 days, 1 month, 2 months and 3 months post-operatively.
Color Match
Tissue color match (CM) will be assessed with adjacent and contralateral palatal tissue (0-no color matching to 10-excellent color matching).
Measured: 3 months post-operatively
Secondary outcomes (6)
Post-operative Pain
Postoperative pain will be evaluated on a Visual analogue scale VAS (0 = no pain to 10 = worst imaginable pain).
Measured: Every day for 7 days, and on the 14th day.
Inflammation Degree
Inflammation degree will be measured on a verbal rating scale (VRS) (0 = no inflammation, 1 = mild inflammation, 2 = marked inflammation, and 3 = extreme inflammation).
Measured: Every day for 7 days, and on the 14th day.
Post-operative Bleeding
Spontaneous bleeding or postoperative delayed bleeding will be assessed (no: no spontaneous bleeding/yes: there is spontaneous bleeding).
Measured: Every day for 7 days, and on the 14th day.
Presence of Hyperesthesia
Presence of hyperesthesia will be evaluated using a Verbal Rating Scale VRS (1 = none; 2 = mild, with no interference in normal life activities; and 3 = severe, with interference in normal life activities).
Measured: Every day for 7 days, and on the 14th day.
Number of Analgesic Pills Taken
Number of analgesic pills taken by the patient post-operatively will be recorded. Minimal amount of analgesic pills taken indicate minimal post-operative pain, whereas excess use of analgesic pills indicate increased post-operative pain.
Measured: During the first 14 days post-operatively.
Oral Health related Quality of Life
A questionnaire will be given to the participants to evaluate how the surgery affected patients' daily activities, physical state, psychological state, and oral hygiene performance. The questions will be answered with very often, fairly often, occasionally, hardly ever, never, and don't know.
Measured: During the first 14 days post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start4 Aug 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palate; WoundStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayer Aboelsaad, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086482
- Sponsor's protocol ID
- 2024-H-0140-D-M-0588
- Acronym
- RCT
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cyanoacrylate Tissue Adhesive Versus Collagen Sponge on Palatal Donor Site Healing After Harvesting a Free Gingival Graft: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07086482
- Acronym / sponsor ID
- RCT / 2024-H-0140-D-M-0588
- Conditions
- Palate; Wound
- Keywords
- palatal donor area, Cyanoacrylate glue, wound healing, free gingival graft
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 25 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.
The goal of this clinical trial is to learn if the use of cyanoacrylate glue (PeriAcryl) is effective in healing of the palatal donor site in adults requiring a free gingival graft.
The main question[s] it aims to answer [is/are]:
Does PeriAcryl accelerate the palatal tissue healing compared with the use of collagen sponge? Does PeriAcryl usage leave the patients more satisfied?
Researcher will compare the outcomes of participants treated with PeriAcryl to those treated with collagen sponge to see if PeriAcryl accelerated the healing process of palatal tissues and led to fewer postoperative complications.
Participants will:
- be assigned to a study group using PeriAcryl or control group using Collagen sponge.
- be followed-up to monitor healing and gather clinical information.
Detailed description
This study investigates new approaches to make management of the palatal donor area easier to the operator and more comfortable to the patient. More specifically, it compares the use of PeriAcryl glue (PA) to the use of collagen sponge after harvesting a free gingival graft from the palate in terms of wound healing and epithelization primarily, and patients satisfaction and oral health related quality of life secondarily.
Participants selection:
Healthy patients (with no systemic diseases or coagulation disorders) requiring a free gingival graft to treat a gingival recession or keratinized tissue deficiency around implants and natural teeth will be recruited.
Participants included in this study must have clinically healthy gingiva and good oral hygiene.
Participants grouping:
- Control group: Hemostasis will be achieved by collagen sponge stabilized with 4/0 silk (x) suture on the palatal wound.
- Test group: Cyanoacrylate tissue adhesive (Periacryl®, GluStitch Inc., Canada) will be applied with a pipette following manufacturer's instructions on the entire area of the wound.
All the procedures will be achieved with the full knowledge and consent of the patient. A written informed consent will be obtained for each patient included in this study.
Surgical Protocol:
- Full mouth scaling will be done for every patient at least 2 weeks before the surgery.
- The donor area will be anesthetized using articaine 4% with epinephrine 1:100,000.
- Palatal tissue thickness will be measured using a periodontal probe. Then a free gingival graft (FGG) will be harvested using a 15c blade of 1 to 1.5 mm in thickness, approximately 3 mm away from the palatal gingival margin.
- Pressure will be applied to the donor surface using gauze soaked in saline solution to stop bleeding, while the FGG will be prepared, stabilized and sutured at the recipient site.
- The operator will then receive a sealed envelope holding each patient's assigned grouping as soon as the graft extraction process is finished.
Post-operative Care:
All patients will get the same prescription of antibiotics (Amoxiclave 1g) twice daily for 7 days, and Ibuprofen 600 mg every 8 hours only taken when needed. As well as chlorohexidine 0.12% mouthwash twice daily for 2 weeks.
The same instructions will be given to all the patients (cease smoking, soft diet, oral hygiene, not brushing hard and causing trauma to the surgical site...).
The test group participants receiving PA in the palatal donor will be informed about the material and that it will disintegrate on its own after 10 days.
While the control group participants receiving collagen sponge with (x) sutures in the palatal donor will be informed that the sutures will be removed after 2 weeks.
Following the operation, a questionnaire will be given to each patient asking them to record any spontaneous bleeding of the surgical incision during the first seven days following the procedure, as well as to rate their level of postoperative discomfort using a visual analogue scale (VAS), quantity of analgesics taken, and other questions related to quality of life.
Follow-ups:
All patients will be followed-up at 7, 14, 21 days, 1 month, 2 months, and 3 months, to evaluate healing up to the formation of the first epithelial layer as evaluated by pressure with a periodontal probe and Laundry wound healing index, and the time of complete integrity of the treated palatal fibromucosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen sponge | Active comparator | Device: Collagen spongeParticipants will be treated with collagen sponge at the palatal donor wound to achieve hemostasis. After FGG harvest, pressure will be applied at the palatal wound using a gauze soaked in saline to top the bleeding, then a collagen sponge will be placed and stabilized with 4/0 silk (x) sutures. |
| Cyanoacrylate tissue adhesive | Experimental | Combination Product: Cyanoacrylate tissue adhesiveParticipants will be treated with cyanoacrylate tissue adhesive (PeriAcryl) at the palatal donor wound to achieve hemostasis. After FGG harvest, pressure will be applied at the palatal wound using a gauze soaked in saline to top the bleeding, then PeriAcryl will be applied with a pipette following manufacturer's instructions on the entire area of the wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Low-moderate anesthetic risk (ASA I-II)
- No restriction on ethnicity or gender
- Patients requiring FGG from the palate for periodontal plastic surgery
- Clinically healthy gingiva after phase I therapy
- Full-mouth plaque index grades 0 and 1
Key exclusion criteria (8 listed)
- Patients who smoke > 10 cigarettes/day
- Patients with coagulation disorders
- Systemic diseases
- Patients on certain medications that may affect periodontal tissues
- Pregnant and lactating patient
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 |
|---|---|---|
| Cyanoacrylate tissue adhesiveAlso: PeriAcrylCyanoacrylate tissue adhesive is a chemical synthetic and hybrid tissue sealant possessing strong, rapid acting adhesive properties and is often used in general surgery. Recently, cyanoacrylate tissue adhesive has been effectively introduced into dentistry to close wounds and stop ischemic areas from forming in periodontal aesthetic surgeries. As well as in exposed membranes to preserve the bone graft after guided bone regeneration, in post-extraction sockets, and to seal any surgical flap. This material has strong hemostatic, bacteriostatic, and sealing qualities. | Combination product | Cyanoacrylate tissue adhesive |
| Collagen spongeCollagen sponge is an organic polymer that promotes the development of blood clots, and it resorbs quickly and completely over time. Collagen sponge create a matrix at the bleeding site, encourage platelet activation and aggregation, and engage the extrinsic coagulation pathway. Thus, it can be utilized as the first choice for wound healing. | Device | Collagen sponge |
Primary outcome
Healing of palatal wound
Time frame: 1 month, 2 months and 3 months post-operatively.
Healing will be evaluated using Laundry Wound Healing Index (WHI). WHI has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins, and amount of suppuration.
Epithelization of the palatal wound
Time frame: On every follow-up session: 7 days, 14 days, 21 days, 1 month, 2 months and 3 months post-operatively.
The complete epithelialization will be evaluated clinically by applying 3% hydrogen peroxide into the palatal wound. If bubble formation is not observed, epithelization will be recorded as complete, whereas if bubbles are observed, epithelization will be recorded as incomplete.
Color Match
Time frame: 3 months post-operatively
Tissue color match (CM) will be assessed with adjacent and contralateral palatal tissue (0-no color matching to 10-excellent color matching).
6 secondary outcomes
Post-operative Pain
Time frame: Every day for 7 days, and on the 14th day.
Inflammation Degree
Time frame: Every day for 7 days, and on the 14th day.
Post-operative Bleeding
Time frame: Every day for 7 days, and on the 14th day.
Presence of Hyperesthesia
Time frame: Every day for 7 days, and on the 14th day.
Number of Analgesic Pills Taken
Time frame: During the first 14 days post-operatively.
Oral Health related Quality of Life
Time frame: During the first 14 days post-operatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Palate; Wound
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Recruiting
Dynamics of Wound Healing in Patients With Obesity
Wound Healing
Active, not recruiting
Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing
Palatal Donor Site Wound Healing
Recruiting
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Mucosal Erosion, Gingival Recession
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.
Nayer Aboelsaad study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cyanoacrylate tissue adhesive and Collagen sponge in people with Palate; Wound, run by Beirut Arab University at 1 site in Lebanon.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Aug 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 Lebanon. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dania EL Rostom, MSc Oral and Dental Surgery (+96171659355, daniarostom1999@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of palatal wound (time frame: 1 month, 2 months and 3 months post-operatively.). The study lists 3 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 17 Aug 2025.