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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
A self-securing monofilament suture with microscopic barbs that eliminate the need for surgical knots during wound closure.
A bacteriostatic tissue adhesive applied to approximated wound edges to provide secure closure and a microbial barrier.
Conventional polyglycolic acid (PGA) resorbable sutures used with standard surgical knot-tying techniques.
Faculty of Oral and Dental Medicine, Future University in Egypt
New Cairo, Cairo Governorate, Egypt
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.
Time frame: 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.
Time frame: 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).
Time frame: 1st, 3rd, and 7th post-operative days.
Post-operative Edema
Clinical assessment of facial swelling after surgery, categorized as (None, Mild, Moderate, or Severe).
Time frame: 1st, 3rd, and 7th post-operative days.
Wound Dehiscence
Presence or absence of any separation of the wound margins after suture or glue application.
Time frame: 1st, 3rd, and 7th post-operative days.
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