Use of Cyanoacrylate in Healing and Pain in the Palatal Donor Site of Connective Tissue Grafts

NCT ID: NCT06116539

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-05-31

Brief 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 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.

Conditions

Pain, Postoperative; Healing Surgical Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Cyanoacrylate Group

In the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.

Group Type: EXPERIMENTAL

Cyanoacrylate

Intervention Type: DRUG

In the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.

Suture Group

In the control group, the edges will be approximated with 4/0 monofilament non-absorbable nylon suture (Aragó, Barcelona, Spain).

Group Type: ACTIVE_COMPARATOR

Suture

Intervention Type: PROCEDURE

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).

Interventions

Cyanoacrylate

In the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.

Intervention Type: DRUG

Suture

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The patient must be considered a candidate for mucogingival treatment
• Requiring grafting around teeth or implants.
• No age limit is established for the sample.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alfonso X El Sabio University

OTHER

Sponsor Role: lead

Responsible Party

Joaquin Lopez-Malla

Master on Oral Surgery, Implantology and Periodontic´s professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquín LM Matute, dentistry

Role: STUDY_DIRECTOR

Alfonso X El Sabio University

Locations

Joaquín López-Malla Matute

A Coruña, La Coruña, Spain

Countries

Spain

Central Contacts

Joaquín LM Matute, dentistry

Role: CONTACT

joaquinlopezmalla@gmail.com

659350394 ext. +34

Marc C Raga, student

Role: CONTACT

marc.carceles@hotmail.es

692486116 ext. +34

Facility Contacts

Joaquín LM Matute, dentistry

Role: primary

joaquinlopezmalla@gmail.com

659350394 ext. +34

Marc C Raga, student

Role: backup

marc.carceles@hotmail.es

692486116 ext. +34

References

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.

Reference Type: BACKGROUND

PMID: 35775864 (View on PubMed)

Basma 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.

Reference Type: BACKGROUND

PMID: 35754198 (View on PubMed)

Castro-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.

Reference Type: BACKGROUND

PMID: 34832409 (View on PubMed)

Stavropoulou 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.

Reference Type: BACKGROUND

PMID: 30517975 (View on PubMed)

Tavelli 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.

Reference Type: BACKGROUND

PMID: 30304077 (View on PubMed)

Tavelli 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.

Reference Type: BACKGROUND

PMID: 29713890 (View on PubMed)

Other Identifiers

cyanoacrylate multicenter

Identifier Type: -

Identifier Source: org_study_id