Intraoral Surgical Incisions, Non-restorable Teeth, Surgical Tooth Extraction, Wound Closure
Conditions
Keywords
Knotless Barbed Suture, N-Butyl Cyanoacrylate Glue, Tissue Adhesive, Wound Healing, Post-operative Pain
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: 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.
Interventions
DEVICEPDO Knotless Barbed Suture
A self-securing monofilament suture with microscopic barbs that eliminate the need for surgical knots during wound closure.
DEVICEN-Butyl Cyanoacrylate Glue (PERIACRYL)
A bacteriostatic tissue adhesive applied to approximated wound edges to provide secure closure and a microbial barrier.
DEVICE3/0 Resorbable PGA Suture
Conventional polyglycolic acid (PGA) resorbable sutures used with standard surgical knot-tying techniques.
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure Time | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Edema | 1st, 3rd, and 7th post-operative days. | Clinical assessment of facial swelling after surgery, categorized as (None, Mild, Moderate, or Severe). |
| Wound Dehiscence | 1st, 3rd, and 7th post-operative days. | Presence or absence of any separation of the wound margins after suture or glue application. |
Countries
Egypt
Contacts
STUDY_CHAIRLobna Abdel Aziz, PHD
Faculty of oral & dental medicine, Future University in Egypt
STUDY_DIRECTORMahmoud Mohsen El Arini, PHD
Faculty of oral & dental medicine, Future University in Egypt
STUDY_CHAIRAbeer Kamal, PHD
Faculty of oral & dental medicine, Misr university for science & technology
Outcome results
None listed