NCT06116539

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Alfonso X El Sabio University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-03-01
• Completion: 2024-05-01
• First posted: 2023-11-03
• Last updated: 2023-11-03

Locations

1 site across 1 country: Spain