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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Knotless Barbed Suture | Experimental | 10 patients will receive wound closure using PDO Knotless barbed suture material (RTMED) after surgical extraction. |
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| Group B: N-Butyl Cyanoacrylate Glue | Experimental | 10 patients will receive wound closure using N-butyl cyanoacrylate glue (PERIACRYL) after surgical extraction. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDO Knotless Barbed Suture | Device | A self-securing monofilament suture with microscopic barbs that eliminate the need for surgical knots during wound closure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Edema | Clinical assessment of facial swelling after surgery, categorized as (None, Mild, Moderate, or Severe). | 1st, 3rd, and 7th post-operative days. |
| Wound Dehiscence | Presence or absence of any separation of the wound margins after suture or glue application. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine, Future University in Egypt | New Cairo | Cairo Governorate | 11835 | Egypt |
Data are not available due to privacy and ethical restrictions.
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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.
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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.
| 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. |
|
| 1st, 3rd, and 7th post-operative days. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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