Wound Healing and Bacterial Adherence With Triclosan-Coated Sutures After Mandibular Impacted Third Molar Surgery

NCT07386366 | Recruiting

• 1 other identifier: 3774/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Impacted Mandibular Third Molar; Postoperative Wound Healing

Keywords

Triclosan-coated suture; Polyglactin 910; Impacted third molar surgery; Mandibular third molar; Oral surgery; Postoperative wound healing; Bacterial adhesion; Antibacterial suture

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (3)

• Soft-tissue wound healing (IPR score)

  Postoperative days 3, 5, and 7 after each surgery (Period 1 and Period 2).

• Postoperative pain (VAS 0-100)

  Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2).

• Postoperative swelling (VAS 0-100)

  Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2).

Study Arms (2)

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.

Device: Triclosan-coated Polyglactin 910 suture; Device: Non-coated polyglactin 910 suture

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.

Device: Triclosan-coated Polyglactin 910 suture; Device: Non-coated polyglactin 910 suture

Interventions

Triclosan-coated Polyglactin 910 suture DEVICE

Absorbable braided polyglactin 910 suture coated with triclosan for wound closure after mandibular impacted third molar surgery.

Sequence 1: Triclosan-coated → Non-coated; Sequence 2: Non-coated → Triclosan-coated

Non-coated polyglactin 910 suture DEVICE

Absorbable braided polyglactin 910 suture without triclosan coating for wound closure after mandibular impacted third molar surgery.

Sequence 1: Triclosan-coated → Non-coated; Sequence 2: Non-coated → Triclosan-coated

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Able and willing to provide written informed consent.
• No active infection associated with the mandibular third molar at the time of enrollment.

You may not qualify if:

• 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.
• Unable to attend scheduled follow-up visits.
• Difference in surgical extraction time between the two procedures is 12 minutes or more.
• Suture loss/loosening before completion of the final assessment time point.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Specialized Dental Clinic, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Vietnam

RECRUITING

Study Officials

• Son Hoang Le

  Department of Oral Surgery, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY CHAIR

Central Study Contacts

Le Khanh Huyen Nguyen

CONTACT

84981869502; nlkhuyen.ths.rhm24@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 4, 2026
• Study Start: October 7, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)