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Not yet recruitingNCT07794280Updated Oct 13, 2026

Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery

An interventional study of Chlorhexidine Diacetate-Coated Polyglactin 910 Suture and Uncoated Polyglactin 910 Suture in Impacted Third Molar Tooth and Surgical Wound Healing, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Not yet recruiting. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment

Updated Oct 13, 2026Start date movedStudy completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

This study evaluates whether coating Polyglactin 910 sutures with chlorhexidine diacetate (CHX-DA) improves outcomes after the surgical removal of impacted mandibular (lower) third molars (wisdom teeth).

The study is a randomized, triple-blind, split-mouth clinical trial. Eligible participants are patients aged 18 to 35 years who need extraction of two symmetrical impacted lower wisdom teeth of similar difficulty. For each participant, one extraction site is closed with standard Polyglactin 910 sutures and the other site is closed with chlorhexidine diacetate-coated Polyglactin 910 sutures, with the allocation assigned by random draw. Participants, the surgeon, and the outcome assessors are all blinded to which suture is used at each site.

The researchers compare the two suture types on the bacterial load at the surgical wound site and on soft tissue healing. Bacterial load is assessed from gingival crevicular fluid collected at the wound site next to the suture and quantified by viability real-time PCR (vPCR, copies/mL). Soft tissue healing is assessed using the IPR healing scale. Both outcomes are measured on days 3, 5, and 7 after surgery.

The aim is to determine whether the chlorhexidine-coated suture reduces bacterial load at the wound site and improves soft tissue healing compared with the uncoated suture.

Read the detailed description

Surgical removal of impacted mandibular third molars is a common oral surgery procedure that carries a risk of postoperative complications such as wound infection, delayed healing, pain, and swelling. Sutures used to close the extraction site can act as a surface for bacterial adhesion from the oral cavity, which may increase the risk of infection at the wound.

Antibacterial-coated sutures have been developed to reduce bacterial colonization and support wound healing. While triclosan-coated sutures have been widely studied, there is limited direct evidence on Polyglactin 910 sutures coated with chlorhexidine diacetate (CHX-DA), particularly in oral surgery. Existing local studies have mostly focused on chlorhexidine solutions or gels for postoperative care rather than on the suture material itself.

This trial uses a split-mouth design, in which each participant receives both suture types at two symmetrical extraction sites, allowing a within-patient comparison that reduces the influence of individual differences. Bacterial load is measured from gingival crevicular fluid collected at the wound site using sterile autoclaved paper cones and quantified by viability real-time PCR (vPCR) for a panel of oral bacterial species. Soft tissue healing is evaluated using the IPR healing scale. Assessments are performed on days 3, 5, and 7 after surgery.

02

Conditions studied

  • Impacted Third Molar Tooth
  • Surgical Wound Healing

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Keywords

  • Polyglactin 910
  • Chlorhexidine diacetate
  • Antibacterial sutures
  • Third molar surgery
  • Split-mouth
  • Bacterial load
03

In context

Surgical Wound

315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.

This study's planned enrollment of 20 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 to 35 years
  • Patients indicated for surgical removal of an impacted mandibular (lower) third molar
  • Patients with two symmetrical impacted mandibular third molars of the same difficulty level according to the Pell-Gregory classification, with a difference in the angulation of the tooth axis (Winter classification) between the two teeth not exceeding 15 degrees

Exclusion criteria

Exclusion Criteria:

  • Patients whose adjacent mandibular second molar is severely decayed/broken down, has only a residual root, or has been extracted
  • Patients using local or systemic antibiotics within 4 weeks before surgery
  • Patients using anti-inflammatory drugs or hormonal medications
  • Patients who are pregnant or breastfeeding
  • Patients allergic to any component of 2% lidocaine with 1:100,000 epinephrine or to any other medication used in the study
  • Patients with systemic diseases such as hypertension, diabetes mellitus, blood disorders, or immunodeficiency that may affect the study results
  • Patients with poor oral hygiene, long-term smoking, or chronic alcohol dependence
  • Patients with radiographic signs suggesting a tumor or cyst associated with the mandibular third molar
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Chlorhexidine Diacetate-Coated Polyglactin 910 Suture

    The extraction site is closed with Polyglactin 910 sutures coated with chlorhexidine diacetate (CHX-DA).

    Device: Chlorhexidine Diacetate-Coated Polyglactin 910 Suture

  • Active comparator
    Uncoated Polyglactin 910 Suture

    The extraction site is closed with standard uncoated Polyglactin 910 sutures.

    Device: Uncoated Polyglactin 910 Suture

Interventions

  • DeviceChlorhexidine Diacetate-Coated Polyglactin 910 Suture

    Polyglactin 910 absorbable suture coated with chlorhexidine diacetate, used to close one extraction site after impacted lower third molar surgery.

  • DeviceUncoated Polyglactin 910 Suture

    Standard uncoated Polyglactin 910 absorbable suture, used to close the other extraction site after impacted lower third molar surgery.

06

What researchers measure

Primary outcomes

  1. Bacterial Load at the Surgical Wound Site

    Bacterial load measured from gingival crevicular fluid collected at the extraction wound site next to the suture using sterile autoclaved paper cones, quantified by viability real-time PCR (vPCR), reported in copies/mL.

    Time frame: Postoperative days 3, 5, and 7

  2. Soft Tissue Healing

    Soft tissue healing at the extraction site assessed using the Inflammatory-Proliferative-Remodeling (IPR) healing scale (inflammatory phase criteria, based on Hamzani et al., 2018 \[PMID: 30324746\]). The scale consists of 8 items (spontaneous or provoked bleeding, granulation tissue, hematoma, soft tissue color, wound margin, suppuration, swelling, and pain), each scored 0 or 1, giving a total score ranging from 0 to 8. Higher scores indicate better soft tissue healing. Total scores are further categorized as poor (≤3), moderate (\>3 to ≤6), and good (\>6).

    Time frame: Postoperative days 3, 5, and 7

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Chaganti S, Kunthsam V, Velangini SY, Alzahrani KJ, Alzahrani FM, Halawani IF, Alshahrani M, Ashi H, Baeshen HA, Patil S. Comparison of bacterial colonization on absorbable non-coated suture with Triclosan- or Chlorhexidine-coated sutures: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2023 Sep;27(18):8371-8383. doi: 10.26355/eurrev_202309_33760. PubMed 37782154 ↗
  • Mohan S, Jayanth BS, Saralaya S, Sunil SM, Sageer ASM, Harikrishnan R. Comparative Study on the Efficacy of Postsurgical Oral Prophylactic Antibiotic Versus Antimicrobial Suture Placement Alone in Preventing Surgical Site Infection After Removal of Impacted Mandibular Third Molar. J Maxillofac Oral Surg. 2020 Dec;19(4):546-551. doi: 10.1007/s12663-019-01267-0. Epub 2019 Aug 2. PubMed 33071503 ↗

Individual participant data

Plan to share: Undecided — A decision on sharing individual participant data has not yet been made.

09

Updates

1 registry update since Sep 25, 2026
Start date
Aug 2026→Oct 20, 2026
Oct 13, 2026
Study completion
Sep 2027→Aug 2027
Oct 13, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionSoft Tissue Healing: how it is measured was reworded
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Start date Aug 2026→Oct 20, 2026
    Study completion Sep 2027→Aug 2027
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionSoft Tissue Healing: how it is measured was reworded
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07794280
Responsible party
Pham Trung Dung (Principal Investigator, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
Aug 31, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Dung Pham, DDS
Contact
trungdung.yds17@gmail.com
+84 852 777 319

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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