NCT07491276

Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions

Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions (Randomized Controlled Clinical Study).

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Future University in Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This clinical study aims to compare the efficacy of knotless barbed sutures versus N-butyl cyanoacrylate glue tissue adhesive for the closure of intra-oral surgical incisions, with traditional PGA vicryl sutures as a control group. The study evaluates three primary outcomes: the time required for incision closure, postoperative pain levels using the Visual Analog Scale (VAS) score, and the soft tissue healing progress using Landry's wound healing index. Secondary outcomes will include the assessment of postoperative edema and other clinical healing parameters. The goal is to determine which closure technique provides superior surgical efficiency, less patient discomfort, and better wound healing in oral and maxillofacial procedures.

Detailed description

Background and Rationale: Conventional intraoral suturing requires the placement of knots to secure the material and maintain tension. However, this presents technical challenges such as restricted access and difficulty in instrumentation. Knots are also associated with complications like food debris accumulation, microbial colonization, and tissue irritation. This study evaluates two modern alternatives-knotless barbed sutures and N-butyl cyanoacrylate glue-to overcome these limitations. Objectives: The primary objective is to compare the efficacy of knotless barbed sutures and N-butyl cyanoacrylate glue against traditional resorbable PGA sutures for intraoral surgical incisions. The study focuses on improving wound closure, healing, and decreasing post-operative pain and edema. Methods: This randomized controlled clinical trial includes 30 patients (18-50 years old) requiring surgical extraction of non-restorable teeth. Participants are randomly assigned to three groups: * Group A: Closure using PDO Knotless barbed sutures (RTMED). * Group B: Closure using N-butyl cyanoacrylate glue (PERIACRYL). * Group C (Control): Closure using 3/0 resorbable PGA sutures. Procedures and Follow-up: After surgical extraction under local anesthesia, the wound is closed according to the assigned group. Post-operative care includes antibiotics (Amoxicillin) and analgesics (Diclofenac potassium). Patients are evaluated on the 1st, 3rd, and 7th post-operative days. Outcome Measures: * Primary Outcomes: Wound closure time (seconds), post-operative pain (VAS score), and wound healing (Landry's index). * Secondary Outcomes: Post-operative edema (mm) and assessment of complications like dehiscence or infection.

Conditions

• Non-restorable Teeth
• Intraoral Surgical Incisions
• Wound Closure
• Surgical Tooth Extraction

Interventions

Type	Name	Description
DEVICE	PDO Knotless Barbed Suture	A self-securing monofilament suture with microscopic barbs that eliminate the need for surgical knots during wound closure.
DEVICE	N-Butyl Cyanoacrylate Glue (PERIACRYL)	A bacteriostatic tissue adhesive applied to approximated wound edges to provide secure closure and a microbial barrier.
DEVICE	3/0 Resorbable PGA Suture	Conventional polyglycolic acid (PGA) resorbable sutures used with standard surgical knot-tying techniques.

Timeline

• Start date: 2025-06-16
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2026-03-24
• Last updated: 2026-03-25

Locations

1 site across 1 country: Egypt