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

NCT07491276 | Active Not Recruiting

• 1 other identifier: KBS vs CA in surgical wounds
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Knotless Barbed Suture; N-Butyl Cyanoacrylate Glue; Tissue Adhesive; Wound Healing; Post-operative Pain

Outcome Measures

Primary Outcomes (3)

• Wound Closure Time

  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

  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

  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 Outcomes (2)

• Post-operative Edema

  1st, 3rd, and 7th post-operative days.

• Wound Dehiscence

  1st, 3rd, and 7th post-operative days.

Study Arms (3)

Group A: Knotless Barbed Suture

EXPERIMENTAL

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

Device: PDO Knotless Barbed Suture

Group B: N-Butyl Cyanoacrylate Glue

EXPERIMENTAL

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

Device: N-Butyl Cyanoacrylate Glue (PERIACRYL)

Group C: Conventional PGA Suture

ACTIVE COMPARATOR

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

Device: 3/0 Resorbable PGA Suture

Interventions

N-Butyl Cyanoacrylate Glue (PERIACRYL) DEVICE

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

Group B: N-Butyl Cyanoacrylate Glue

3/0 Resorbable PGA Suture DEVICE

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

Group C: Conventional PGA Suture

PDO Knotless Barbed Suture DEVICE

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

Group A: Knotless Barbed Suture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Faculty of Oral and Dental Medicine, Future University in Egypt

New Cairo, Cairo Governorate, 11835, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Lobna Abdel Aziz, PHD

  Faculty of oral & dental medicine, Future University in Egypt

  STUDY CHAIR

• Mahmoud Mohsen El Arini, PHD

  Faculty of oral & dental medicine, Future University in Egypt

  STUDY DIRECTOR

• Abeer Kamal, PHD

  Faculty of oral & dental medicine, Misr university for science & technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the intervention groups. Due to the nature of the surgical materials, the operator cannot be blinded; however, patients will not be informed of the specific wound closure material used in their surgical site.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Candidate, Department of Oral and Maxillofacial Surgery

Model Details: This is a randomized, three-arm, parallel-group clinical trial. Participants requiring surgical extraction of non-restorable teeth are randomly allocated into one of three groups to compare different wound closure techniques: knotless barbed sutures, N-butyl cyanoacrylate glue, and conventional resorbable PGA sutures.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: June 16, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)