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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:
Participants will:
This randomized, double-blind, two-period crossover clinical trial evaluates the antibacterial performance of triclosan-coated polyglactin 910 sutures compared with standard (non-coated) polyglactin 910 sutures following impacted mandibular third molar surgery. The study is designed to determine whether triclosan coating reduces bacterial adherence/amount on suture material during early postoperative healing and to examine associated soft-tissue healing.
Each participant undergoes two separate surgical extractions of impacted mandibular third molars performed on different occasions 4 weeks apart. The operated side (right or left) may vary by case and is recorded; treatment assignment is based on surgery order (period 1 versus period 2). Participants are randomized to one of two sequences: (A) triclosan-coated suture in the first surgery followed by non-coated suture in the second surgery, or (B) the reverse sequence. Standardized perioperative management is used across both periods to reduce procedural variability.
Masking is maintained for participants and outcome assessors. Allocation is concealed and documented for analysis after data collection. For each surgery, follow-up assessments are conducted during the first postoperative week using prespecified clinical evaluations and laboratory testing of a small collected suture segment, with consistent follow-up timing across both periods. Follow-up visits occur on postoperative days 3, 5, and 7 after each surgery.
The crossover design enables within-participant comparisons between suture types, reducing inter-individual variation in oral microbiota and healing response. The 4-week interval between procedures is intended to minimize carryover effects from the first surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Triclosan-coated → Non-coated | Other | Two-period crossover. Period 1 (first surgery): triclosan-coated polyglactin 910 suture. Period 2 (second surgery, approximately 4 weeks later): non-coated polyglactin 910 suture. Operated side (right/left) may vary by case; assignment is based on surgery order. |
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| Sequence 2: Non-coated → Triclosan-coated | Other | Two-period crossover. Period 1 (first surgery): non-coated polyglactin 910 suture. Period 2 (second surgery, approximately 4 weeks later): triclosan-coated polyglactin 910 suture. Operated side (right/left) may vary by case; assignment is based on surgery order. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan-coated Polyglactin 910 suture | Device | Absorbable braided polyglactin 910 suture coated with triclosan for wound closure after mandibular impacted third molar surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Le Khanh Huyen Nguyen | Contact | 84981869502 | nlkhuyen.ths.rhm24@ump.edu.vn |
| Name | Affiliation | Role |
|---|---|---|
| Son Hoang Le | Department of Oral Surgery, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialized Dental Clinic, University of Medicine and Pharmacy at Ho Chi Minh City | Recruiting | Ho Chi Minh City | Vietnam |
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| Non-coated polyglactin 910 suture | Device | Absorbable braided polyglactin 910 suture without triclosan coating for wound closure after mandibular impacted third molar surgery. |
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| Postoperative days 3, 5, and 7 after each surgery (Period 1 and Period 2). |
| 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 days 3, 5, and 7 after each surgery (period 1 and period 2). |
| 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. | Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2). |