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

Future University in Egypt

Status: Active, not recruiting

Conditions: Non-restorable Teeth; Wound Closure; Surgical Tooth Extraction; Intraoral Surgical Incisions

Treatments: Device: N-Butyl Cyanoacrylate Glue (PERIACRYL); Device: PDO Knotless Barbed Suture; Device: 3/0 Resorbable PGA Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT07491276

KBS vs CA in surgical wounds

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring Intra-oral wound closure following intra-oral incisions after surgical extraction of non-restorable teeth.
• Good oral hygiene.
• Highly motivated patients
• Patients agreed to follow-up for post-operative evaluation with informed consent
• Age between 18- 50 years old
• Both genders: Males & Females

Exclusion criteria

• Medically compromised patients as uncontrolled Diabetes, uncontrolled hypertension.
• Patients on chemotherapy or radiation.
• Patients with bad oral hygiene .
• Uncooperative patients: mentally retarded patients.
• Heavy smokers. ( > 1 pack/day).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Group A: Knotless Barbed Suture

Experimental group

Description:

10 patients will receive wound closure using PDO Knotless barbed suture material (RTMED) after surgical extraction.

Treatment:

Device: PDO Knotless Barbed Suture

Group B: N-Butyl Cyanoacrylate Glue

Experimental group

Description:

10 patients will receive wound closure using N-butyl cyanoacrylate glue (PERIACRYL) after surgical extraction.

Treatment:

Device: N-Butyl Cyanoacrylate Glue (PERIACRYL)

Group C: Conventional PGA Suture

Active Comparator group

Description:

10 patients will receive wound closure using traditional 3/0 resorbable polyglycolic acid (PGA) sutures after surgical extraction.

Treatment:

Device: 3/0 Resorbable PGA Suture