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

March 23, 2026 updated by: Ahmed Khaled Mohamed Kenany, Future University in Egypt

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • New Cairo, Cairo Governorate, Egypt, 11835
        • Faculty of Oral and Dental Medicine, Future University in Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Knotless Barbed Suture
10 patients will receive wound closure using PDO Knotless barbed suture material (RTMED) after surgical extraction.
Device: PDO Knotless Barbed Suture
A self-securing monofilament suture with microscopic barbs that eliminate the need for surgical knots during wound closure.
Experimental: Group B: N-Butyl Cyanoacrylate Glue
10 patients will receive wound closure using N-butyl cyanoacrylate glue (PERIACRYL) after surgical extraction.
Device: N-Butyl Cyanoacrylate Glue (PERIACRYL)
A bacteriostatic tissue adhesive applied to approximated wound edges to provide secure closure and a microbial barrier.
Active Comparator: Group C: Conventional PGA Suture
10 patients will receive wound closure using traditional 3/0 resorbable polyglycolic acid (PGA) sutures after surgical extraction.
Device: 3/0 Resorbable PGA Suture
Conventional polyglycolic acid (PGA) resorbable sutures used with standard surgical knot-tying techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Closure Time
Time Frame: Intra-operatively (at the time of surgery_
The total duration required to achieve clinical closure of the intraoral surgical incision. Measurement starts from the first needle penetration (for suture groups) or the beginning of adhesive application (for the glue group) and ends when the wound edges are fully secured.
Intra-operatively (at the time of surgery_
Post-operative Pain Level
Time Frame: 1st, 3rd, and 7th post-operative days.
Assessment of patient discomfort using the Visual Analogue Scale (VAS). The scale consists of a 10-cm horizontal line with "No Pain" at 0 and "Worst Imaginable Pain" at 10. Patients will mark their perceived pain level on this line.
1st, 3rd, and 7th post-operative days.
Soft Tissue Healing
Time Frame: 1st, 3rd, and 7th post-operative days.
Clinical assessment of the surgical site healing using Landry's Wound Healing Index. This index evaluates five clinical parameters: tissue color, response to palpation, presence of granulation tissue, incision margin, and presence of suppuration. Scores range from 1 (Very Poor) to 5 (Excellent).
1st, 3rd, and 7th post-operative days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Edema
Time Frame: 1st, 3rd, and 7th post-operative days.
Clinical assessment of facial swelling after surgery, categorized as (None, Mild, Moderate, or Severe).
1st, 3rd, and 7th post-operative days.
Wound Dehiscence
Time Frame: 1st, 3rd, and 7th post-operative days.
Presence or absence of any separation of the wound margins after suture or glue application.
1st, 3rd, and 7th post-operative days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Investigators

  • Study Chair: Lobna Abdel Aziz, PHD, Faculty of oral & dental medicine, Future University in Egypt
  • Study Director: Mahmoud Mohsen El Arini, PHD, Faculty of oral & dental medicine, Future University in Egypt
  • Study Chair: Abeer Kamal, PHD, Faculty of oral & dental medicine, Misr university for science & technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBS vs CA in surgical wounds

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are not available due to privacy and ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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