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NCT Number: NCT07491276

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

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.

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Key information

Conditions

Non-restorable Teeth Intraoral Surgical Incisions Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Tooth Extraction Wound Closure

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine, Future University in Egypt

New Cairo, Cairo Governorate, 11835, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PDO Knotless Barbed Suture

Device

A self-securing monofilament suture with microscopic barbs that eliminate the need for surgical knots during wound closure.

N-Butyl Cyanoacrylate Glue (PERIACRYL)

Device

A bacteriostatic tissue adhesive applied to approximated wound edges to provide secure closure and a microbial barrier.

3/0 Resorbable PGA Suture

Device

Conventional polyglycolic acid (PGA) resorbable sutures used with standard surgical knot-tying techniques.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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

Acronym: KBA vs CA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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