Skip to main content
Clinical Trials/NCT07491276
NCT07491276Active, not recruitingNot Applicable

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

Future University in Egypt1 site in 1 country30 target enrollmentStarted: June 16, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
30
Locations
1
Primary Endpoint
Wound Closure Time

Study Overview

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.

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

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.

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.

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

  • Post-operative Edema(1st, 3rd, and 7th post-operative days.)
  • Wound Dehiscence(1st, 3rd, and 7th post-operative days.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Khaled Mohamed Kenany

Master's Candidate, Department of Oral and Maxillofacial Surgery

Future University in Egypt

Study Sites (1)

Loading locations...

Similar Trials