NCT06083259

Cyanoacrylate With or Without Suture?

Does Cyanoacrylate Require Supportive Suturing to Reduce Seconder Bleeding and Stabilizing Biomaterial at the Donor Site?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. Intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.

Conditions

• Wound Heal

Interventions

Type	Name	Description
DEVICE	Gelatin sponge stabilization with suture and cyanoacrylate	The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group)
PROCEDURE	Gelatin sponge stabilization with cyanoacrylate	Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test group)

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-08-16
• Completion: 2024-08-16
• First posted: 2023-10-13
• Last updated: 2024-08-19

Locations

1 site across 1 country: Turkey (Türkiye)