Pain, PostoperativePhase 1NCT06116539
Use of Cyanoacrylate in Healing and Pain in the Palatal Donor Site of Connective Tissue Grafts
A Phase 1 study testing Cyanoacrylate and Suture in people with Pain, Postoperative and Healing Surgical Wounds, run by Alfonso X El Sabio University at 1 site in Spain.
Trial summary
Periodontal plastic surgery has been performed successfully for a long time in the treatment of gingival recessions and mucogingival defects. Epithelial and connective tissue grafts are considered the "gold standard" treatment for gingival recession due to their biocompatibility and long-term stability, however they… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Healing Surgical Wounds
- What is being tested?
- Cyanoacrylate and Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2024to May 2024
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The patient must be considered a candidate for mucogingival treatment
- Requiring grafting around teeth or implants.
- No age limit is established for the sample.
Who cannot join
- Patients with systemic or scarring compromises
- Treated with bisphosphonates
- Smokers of more than 10 cigarettes a day
- With a history of previous palatal grafting in that location
- Present any type of contraindication to undergo surgery cannot take part in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Joaquín López-Malla Matute
A Coruña, La Coruña, 15011
Joaquín LM Matute, dentistry, 659350394 ext. +34, joaquinlopezmalla@gmail.com
Marc C Raga, student, 692486116 ext. +34, marc.carceles@hotmail.es
About this study
Official title: Multicenter Randomized Clinical Trial of the Use of Cyanoacrylate in Healing and Pain in the Palatal Donor Site of Connective Tissue Grafts
Periodontal plastic surgery has been performed successfully for a long time in the treatment of gingival recessions and mucogingival defects. Epithelial and connective tissue grafts are considered the "gold standard" treatment for gingival recession due to their biocompatibility and long-term stability, however they require tissue harvesting from a donor area, usually the palate, increasing patient discomfort. Various hemostatic and healing agents have been used in conjunction with suturing to speed healing and reduce complications associated with this procedure, such as bleeding and pain. These include absorbable synthetic collagen, absorbable gelatin sponges, oxidized regenerated cellulose, ferric subsulfate, and more recently, cyanoacrylate cements and platelet-rich fibrin. Cyanoacrylate adhesives are synthesized as monomers by condensation of a cyanoacetate with formaldehyde in the presence of catalysts and the adhesive film is developed by rapid polymerization caused by hydroxide groups to the surfaces to be adhered. The properties of cyanoacrylate tissue adhesives of greatest interest in the surgical field are excellent hemostasis, rapid tissue adhesion, and possible bacteriostatic qualities.
Read the detailed description
Periodontal plastic surgery has been performed successfully for a long time in the treatment of gingival recessions and mucogingival defects. Epithelial and connective tissue grafts are considered the "gold standard" treatment for gingival recession due to their biocompatibility and long-term stability, however they require tissue harvesting from a donor area, usually the palate, increasing patient discomfort. Various hemostatic and healing agents have been used in conjunction with suturing to speed healing and reduce complications associated with this procedure, such as bleeding and pain. These include absorbable synthetic collagen, absorbable gelatin sponges, oxidized regenerated cellulose, ferric subsulfate, and more recently, cyanoacrylate cements and platelet-rich fibrin. Cyanoacrylate adhesives are synthesized as monomers by condensation of a cyanoacetate with formaldehyde in the presence of catalysts and the adhesive film is developed by rapid polymerization caused by hydroxide groups to the surfaces to be adhered. The properties of cyanoacrylate tissue adhesives of greatest interest in the surgical field are excellent hemostasis, rapid tissue adhesion, and possible bacteriostatic qualities.
The objective of this study will be to evaluate the perception of pain by the patient in the postoperative period of procedures for taking connective grafts from the palate in which cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) is used in comparison with a control group in which the clot was stabilized with the use of sutures.
Secondary Objectives:
To evaluate the healing of the palate in those patients in whom cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) is used, and compare it with a control group in which the clot is stabilized with the use of suture.
Evaluate the appearance of complications in procedures for taking connective grafts from the palate, such as necrosis or bleeding.
To evaluate the relationship between the dimensions of the connective tissue graft/thickness of the remaining epithelium after taking the graft and the appearance of complications.
Evaluate the time of the procedure in the harvesting of the graft, both in the suture and cyanoacrylate groups.
- Conditions
- Pain, Postoperative, Healing Surgical Wounds
- Being tested
- Cyanoacrylate, Suture
- Keywords
- tissue adhesive, wound dressing, cyanoacrylate, gingival graft, palatal graft, conective tissue graft
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyanoacrylateDrug
In the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.
SutureProcedure or surgery
After harvesting the full-thickness connective tissue graft, the edges of the control group will be approximated with 4/0 non-absorbable monofilament nylon suture (Aragó, Barcelona, Spain).
| Study group | Role | What they receive |
|---|---|---|
| Cyanoacrylate Group | Experimental | In the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied. Receives: Drug: Cyanoacrylate |
| Suture Group | Active comparator | In the control group, the edges will be approximated with 4/0 monofilament non-absorbable nylon suture (Aragó, Barcelona, Spain). Receives: Procedure: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
The pain perceived by the patient will be evaluated by means of a Visual Analogue Scale (calibrated from 0 to 10, with 10 being the worst pain imaginable) during the first 1,2,3,4,5,6,7 and 14 days.
Measured: Days 1,2,3,4,5,6,7 and 14 after the procedure
Secondary outcomes (1)
Donor site healing
Donor site healing will be assessed visually at 7 and 14 days using the modified early wound healing index (MEHI),calibrated from 1 to 5, with 1 being complete closure with flap without a fibrin line on the palate, and 5 being incomplete closure of the flap with complete necrosis of the palatal tissue.
Measured: will be evaluated at 7 and 14 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfonso X El Sabio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquin Lopez-Malla, Alfonso X El Sabio University
- Investigators
- Joaquín LM Matute, dentistry, Study director, Alfonso X El Sabio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116539
- Sponsor's protocol ID
- cyanoacrylate multicenter
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alhourani MA, Kasem T, Hamadah O. Comparative study between using a tissue adhesive (N-BCA & OCA) and surgical sutures in free gingival graft surgery: A randomized controlled clinical trial. Dent Med Probl. 2022 Apr-Jun;59(2):241-248. doi: 10.17219/dmp/135382.
PubMed 35775864Basma HS, Saleh MHA, Abou-Arraj RV, Imbrogno M, Ravida A, Wang HL, Li P, Geurs N. Patient-reported outcomes of palatal donor site healing using four different wound dressing modalities following free epithelialized mucosal grafts: A four-arm randomized controlled clinical trial. J Periodontol. 2023 Jan;94(1):88-97. doi: 10.1002/JPER.22-0172. Epub 2022 Aug 3.
PubMed 35754198Castro-Gaspar C, Olmedo-Gaya MV, Romero-Olid MN, Lisbona-Gonzalez MJ, Vallecillo-Rivas M, Reyes-Botella C. Comparison between Tissue Adhesive Cyanoacrylate and Suture for Palatal Fibromucosa Healing: A Randomized Controlled Study. Materials (Basel). 2021 Nov 19;14(22):7009. doi: 10.3390/ma14227009.
PubMed 34832409Stavropoulou C, Atout RN, Brownlee M, Schroth RJ, Kelekis-Cholakis A. A randomized clinical trial of cyanoacrylate tissue adhesives in donor site of connective tissue grafts. J Periodontol. 2019 Jun;90(6):608-615. doi: 10.1002/JPER.18-0475. Epub 2018 Dec 26.
PubMed 30517975Tavelli L, Asa'ad F, Acunzo R, Pagni G, Consonni D, Rasperini G. Minimizing Patient Morbidity Following Palatal Gingival Harvesting: A Randomized Controlled Clinical Study. Int J Periodontics Restorative Dent. 2018 Nov/Dec;38(6):e127-e134. doi: 10.11607/prd.3581.
PubMed 30304077Tavelli L, Ravida A, Saleh MHA, Maska B, Del Amo FS, Rasperini G, Wang HL. Pain perception following epithelialized gingival graft harvesting: a randomized clinical trial. Clin Oral Investig. 2019 Jan;23(1):459-468. doi: 10.1007/s00784-018-2455-5. Epub 2018 Apr 30.
PubMed 29713890
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial of the Use of Cyanoacrylate in Healing and Pain in the Palatal Donor Site of Connective Tissue Grafts
- ClinicalTrials.gov ID
- NCT06116539
- Acronym / sponsor ID
- cyanoacrylate multicenter
- Conditions
- Pain, Postoperative, Healing Surgical Wounds
- Keywords
- tissue adhesive, wound dressing, cyanoacrylate, gingival graft, palatal graft, conective tissue graft
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alfonso X El Sabio UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 3 Nov 2023 (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.
Periodontal plastic surgery has been performed successfully for a long time in the treatment of gingival recessions and mucogingival defects. Epithelial and connective tissue grafts are considered the "gold standard" treatment for gingival recession due to their biocompatibility and long-term stability, however they require tissue harvesting from a donor area, usually the palate, increasing patient discomfort. Various hemostatic and healing agents have been used in conjunction with suturing to speed healing and reduce complications associated with this procedure, such as bleeding and pain. These include absorbable synthetic collagen, absorbable gelatin sponges, oxidized regenerated cellulose, ferric subsulfate, and more recently, cyanoacrylate cements and platelet-rich fibrin. Cyanoacrylate adhesives are synthesized as monomers by condensation of a cyanoacetate with formaldehyde in the presence of catalysts and the adhesive film is developed by rapid polymerization caused by hydroxide groups to the surfaces to be adhered. The properties of cyanoacrylate tissue adhesives of greatest interest in the surgical field are excellent hemostasis, rapid tissue adhesion, and possible bacteriostatic qualities.
Detailed description
Periodontal plastic surgery has been performed successfully for a long time in the treatment of gingival recessions and mucogingival defects. Epithelial and connective tissue grafts are considered the "gold standard" treatment for gingival recession due to their biocompatibility and long-term stability, however they require tissue harvesting from a donor area, usually the palate, increasing patient discomfort. Various hemostatic and healing agents have been used in conjunction with suturing to speed healing and reduce complications associated with this procedure, such as bleeding and pain. These include absorbable synthetic collagen, absorbable gelatin sponges, oxidized regenerated cellulose, ferric subsulfate, and more recently, cyanoacrylate cements and platelet-rich fibrin. Cyanoacrylate adhesives are synthesized as monomers by condensation of a cyanoacetate with formaldehyde in the presence of catalysts and the adhesive film is developed by rapid polymerization caused by hydroxide groups to the surfaces to be adhered. The properties of cyanoacrylate tissue adhesives of greatest interest in the surgical field are excellent hemostasis, rapid tissue adhesion, and possible bacteriostatic qualities.
The objective of this study will be to evaluate the perception of pain by the patient in the postoperative period of procedures for taking connective grafts from the palate in which cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) is used in comparison with a control group in which the clot was stabilized with the use of sutures.
Secondary Objectives:
To evaluate the healing of the palate in those patients in whom cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) is used, and compare it with a control group in which the clot is stabilized with the use of suture.
Evaluate the appearance of complications in procedures for taking connective grafts from the palate, such as necrosis or bleeding.
To evaluate the relationship between the dimensions of the connective tissue graft/thickness of the remaining epithelium after taking the graft and the appearance of complications.
Evaluate the time of the procedure in the harvesting of the graft, both in the suture and cyanoacrylate groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyanoacrylate Group | Experimental | Drug: CyanoacrylateIn the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied. |
| Suture Group | Active comparator | Procedure: SutureIn the control group, the edges will be approximated with 4/0 monofilament non-absorbable nylon suture (Aragó, Barcelona, Spain). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must be considered a candidate for mucogingival treatment
- Requiring grafting around teeth or implants.
- No age limit is established for the sample.
Key exclusion criteria (5 listed)
- Patients with systemic or scarring compromises
- Treated with bisphosphonates
- Smokers of more than 10 cigarettes a day
- With a history of previous palatal grafting in that location
- Present any type of contraindication to undergo surgery cannot take part in the study.
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 |
|---|---|---|
| CyanoacrylateIn the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied. | Drug | Cyanoacrylate Group |
| SutureAfter harvesting the full-thickness connective tissue graft, the edges of the control group will be approximated with 4/0 non-absorbable monofilament nylon suture (Aragó, Barcelona, Spain). | Procedure or surgery | Suture Group |
Primary outcome
Pain perception
Time frame: Days 1,2,3,4,5,6,7 and 14 after the procedure
The pain perceived by the patient will be evaluated by means of a Visual Analogue Scale (calibrated from 0 to 10, with 10 being the worst pain imaginable) during the first 1,2,3,4,5,6,7 and 14 days.
1 secondary outcome
Donor site healing
Time frame: will be evaluated at 7 and 14 days after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Background: PubMed 35775864Alhourani MA, Kasem T, Hamadah O. Comparative study between using a tissue adhesive (N-BCA & OCA) and surgical sutures in free gingival graft surgery: A randomized controlled clinical trial. Dent Med Probl. 2022 Apr-Jun;59(2):241-248. doi: 10.17219/dmp/135382.
- Background: PubMed 35754198Basma HS, Saleh MHA, Abou-Arraj RV, Imbrogno M, Ravida A, Wang HL, Li P, Geurs N. Patient-reported outcomes of palatal donor site healing using four different wound dressing modalities following free epithelialized mucosal grafts: A four-arm randomized controlled clinical trial. J Periodontol. 2023 Jan;94(1):88-97. doi: 10.1002/JPER.22-0172. Epub 2022 Aug 3.
- Background: PubMed 34832409Castro-Gaspar C, Olmedo-Gaya MV, Romero-Olid MN, Lisbona-Gonzalez MJ, Vallecillo-Rivas M, Reyes-Botella C. Comparison between Tissue Adhesive Cyanoacrylate and Suture for Palatal Fibromucosa Healing: A Randomized Controlled Study. Materials (Basel). 2021 Nov 19;14(22):7009. doi: 10.3390/ma14227009.
- Background: PubMed 30517975Stavropoulou C, Atout RN, Brownlee M, Schroth RJ, Kelekis-Cholakis A. A randomized clinical trial of cyanoacrylate tissue adhesives in donor site of connective tissue grafts. J Periodontol. 2019 Jun;90(6):608-615. doi: 10.1002/JPER.18-0475. Epub 2018 Dec 26.
- Background: PubMed 30304077Tavelli L, Asa'ad F, Acunzo R, Pagni G, Consonni D, Rasperini G. Minimizing Patient Morbidity Following Palatal Gingival Harvesting: A Randomized Controlled Clinical Study. Int J Periodontics Restorative Dent. 2018 Nov/Dec;38(6):e127-e134. doi: 10.11607/prd.3581.
- Background: PubMed 29713890Tavelli L, Ravida A, Saleh MHA, Maska B, Del Amo FS, Rasperini G, Wang HL. Pain perception following epithelialized gingival graft harvesting: a randomized clinical trial. Clin Oral Investig. 2019 Jan;23(1):459-468. doi: 10.1007/s00784-018-2455-5. Epub 2018 Apr 30.
- 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.
Joaquín LM Matute, dentistry study director
Alfonso X El Sabio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyanoacrylate and Suture in people with Pain, Postoperative and Healing Surgical Wounds, run by Alfonso X El Sabio University at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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 Spain. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquín LM Matute, dentistry (659350394 ext. +34, joaquinlopezmalla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (time frame: Days 1,2,3,4,5,6,7 and 14 after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06116539, which also lists 6 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 3 Nov 2023.