Impacted Mandibular Third MolarNCT07386366
Soft Tissue Healing and Bacterial Load With Triclosan-Coated Sutures After Impacted Mandibular Third Molar Surgery
A study testing Triclosan-coated Polyglactin 910 suture and Non-coated polyglactin 910 suture in people with Impacted Mandibular Third Molar and Postoperative Wound Healing, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar, Postoperative Wound Healing
- What is being tested?
- Triclosan-coated Polyglactin 910 suture and Non-coated polyglactin 910 suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteVietnam
- Study dates
- 7 Oct 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Specialized Dental Clinic, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City
About this study
Official title: Evaluation of Soft Tissue Healing and Bacterial Load on Triclosan-Coated Polyglactin 910 Sutures After Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical 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:
Read more
- 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?
- 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.
Read the detailed description
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.
- Being tested
- Triclosan-coated Polyglactin 910 suture, Non-coated polyglactin 910 suture
- Keywords
- Triclosan-coated suture, Polyglactin 910, Impacted third molar surgery, Mandibular third molar, Oral surgery, Postoperative wound healing, Bacterial adhesion, Antibacterial suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan-coated Polyglactin 910 sutureDevice
Absorbable braided polyglactin 910 suture coated with triclosan for wound closure after mandibular impacted third molar surgery.
Non-coated polyglactin 910 sutureDevice
Absorbable braided polyglactin 910 suture without triclosan coating for wound closure after mandibular impacted third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Triclosan-coated Polyglactin 910 suture; Device: Non-coated polyglactin 910 suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2).
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start7 Oct 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third MolarStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Khanh Huyen Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Son Hoang Le, Study chair, Department of Oral Surgery, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386366
- Sponsor's protocol ID
- 3774/ĐHYD-HĐĐĐ
- Status last verified
- Aug 2026
- First submitted
- 19 Jan 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft Tissue Healing and Bacterial Load on Triclosan-Coated Polyglactin 910 Sutures After Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07386366
- Acronym / sponsor ID
- 3774/ĐHYD-HĐĐĐ
- Keywords
- Triclosan-coated suture, Polyglactin 910, Impacted third molar surgery, Mandibular third molar, Oral surgery, Postoperative wound healing, Bacterial adhesion, Antibacterial suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Triclosan-coated → Non-coated | Other | Device: Triclosan-coated Polyglactin 910 suture, Device: Non-coated polyglactin 910 sutureTwo-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. |
| Sequence 2: Non-coated → Triclosan-coated | Other | Device: Triclosan-coated Polyglactin 910 suture, Device: Non-coated polyglactin 910 sutureTwo-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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triclosan-coated Polyglactin 910 sutureAbsorbable braided polyglactin 910 suture coated with triclosan for wound closure after mandibular impacted third molar surgery. | Device | Sequence 1: Triclosan-coated → Non-coated, Sequence 2: Non-coated → Triclosan-coated |
| Non-coated polyglactin 910 sutureAbsorbable braided polyglactin 910 suture without triclosan coating for wound closure after mandibular impacted third molar surgery. | Device | Sequence 1: Triclosan-coated → Non-coated, Sequence 2: Non-coated → Triclosan-coated |
Primary outcome
Oral bacterial load on suture material (real-time PCR)
Time frame: Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2).
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.
3 secondary outcomes
Soft-tissue wound healing (IPR score)
Time frame: Postoperative days 3, 5, and 7 after each surgery (Period 1 and Period 2).
Postoperative pain (VAS 0-100)
Time frame: Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2).
Postoperative swelling (VAS 0-100)
Time frame: Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Son Hoang Le study chair
Department of Oral Surgery, Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triclosan-coated Polyglactin 910 suture and Non-coated polyglactin 910 suture in people with Impacted Mandibular Third Molar and Postoperative Wound Healing, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral bacterial load on suture material (real-time PCR) (time frame: Postoperative days 3, 5, and 7 after each surgery (period 1 and period 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.