About this trial
The goal of this clinical trial is to learn if triclosan-coated absorbable stitches (polyglactin 910 sutures coated with triclosan, an antibacterial agent) help soft tissue heal better and have fewer bacteria stuck to the stitches after lower impacted wisdom tooth surgery in adults aged 18 to 35 years.
The main questions it aims to answer are:
1. Does triclosan-coated polyglactin 910 suture lead to better soft-tissue wound healing than non-coated polyglactin 910 suture on postoperative days 3, 5, and 7 after mandibular impacted third molar surgery? 2. Does triclosan-coated polyglactin 910 suture result in a lower oral bacterial load adhered to the suture material than non-coated polyglactin 910 suture on postoperative days 3, 5, and 7 after mandibular impacted third molar surgery?
Participants will:
* Have surgery to remove two similar lower impacted wisdom teeth (one on each side) * Receive triclosan-coated stitches on one side and standard stitches on the other side, with the side assignment chosen at random * Return for follow-up visits on day three, day five, and day seven after surgery for healing checks, simple ratings of pain and swelling, and collection of a small stitch sample for bacterial testing.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 to 35 years.
American Society of Anesthesiologists (ASA) physical status I or II.
Presence of two symmetric impacted mandibular third molars with the same level of difficulty according to the Pell-Gregory and Winter classification; the difference in angulation between the two third molars is no more than 15 degrees.
No use of topical or systemic antibiotics for at least 4 weeks before surgery.
Disqualifiers
Pregnant or breastfeeding.
Allergy to local anesthetic (2% lidocaine with 1:100,000 epinephrine) or any medications used in the study.
Radiographic findings suggestive of a tumor or cyst associated with the impacted mandibular third molar.
Participant withdraws consent or does not agree to continue participation.
Trial design
Crossover
Treatments tested in this trial
Triclosan-coated Polyglactin 910 suture
DeviceAbsorbable braided polyglactin 910 suture coated with triclosan for wound closure after mandibular impacted third molar surgery.
Non-coated polyglactin 910 suture
DeviceAbsorbable braided polyglactin 910 suture without triclosan coating for wound closure after mandibular impacted third molar surgery.
Treatment groups
Trial outcomes
Primary outcomes
Oral bacterial load on suture material (real-time PCR)
Bacterial load on collected suture segments quantified using real-time polymerase chain reaction (real-time PCR) and compared between triclosan-coated and non-coated polyglactin 910 sutures within participants in a two-period crossover design.
Secondary outcomes
Soft-tissue wound healing (IPR score)
Soft-tissue healing will be assessed using the Inflammatory-Proliferative-Remodeling (IPR) Wound Healing Score (Hamzani 2018). The total IPR score ranges from 0 to 8, with higher scores indicating better healing. At each visit, eight parameters are scored as 0 (unfavorable) or 1 (favorable): bleeding (spontaneous or on palpation), granulation tissue, hematoma, tissue color, incision margins, suppuration, edema (VAS 0-100 mm; 0 = 51-100 mm, 1 = 0-50 mm), and pain (VAS 0-100 mm; 0 = 51-100 mm, 1 = 0-50 mm).
Postoperative pain (VAS 0-100)
Participant-reported pain measured on a 0-100 visual analog scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain.
Postoperative swelling (VAS 0-100)
Participant-reported swelling measured on a 0-100 visual analog scale (VAS), where 0 indicates no swelling and 100 indicates the worst imaginable swelling.
Sponsors and contacts
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