Multicenter Randomized Clinical Trial of the Use of Cyanoacrylate in Healing and Pain in the Palatal Donor Site of Connective Tissue Grafts

Alfonso X El Sabio University1 site in 1 country80 target enrollmentJanuary 2024

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2024

End Date

May 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alfonso X El Sabio University

Responsible Party

Principal Investigator

Joaquin Lopez-Malla

Master on Oral Surgery, Implantology and Periodontic´s professor

Alfonso X El Sabio University

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.

Arms & Interventions

Cyanoacrylate Group

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

Intervention: Cyanoacrylate

Suture Group

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

Intervention: Suture

Outcomes

Primary Outcomes

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.