Impacted Third Molar ToothNCT07794280
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
A study testing Chlorhexidine Diacetate-Coated Polyglactin 910 Suture and Uncoated Polyglactin 910 Suture in people with Impacted Third Molar Tooth and Surgical Wound Healing, run by University of Medicine and Pharmacy at Ho Chi Minh City.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth, Surgical Wound Healing
- What is being tested?
- Chlorhexidine Diacetate-Coated Polyglactin 910 Suture and Uncoated Polyglactin 910 Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to Aug 2027
- Phase
- Interventional
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
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Soft Tissue Healing and Antibacterial Efficacy of Chlorhexidine Diacetate-Coated Polyglactin 910 Sutures in the Surgery of Impacted Mandibular Third Molars: A Randomized, Triple-Blind, Split-Mouth Clinical Trial
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.
Read more
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.
- Conditions
- Impacted Third Molar Tooth, Surgical Wound Healing
- Being tested
- Chlorhexidine Diacetate-Coated Polyglactin 910 Suture, Uncoated Polyglactin 910 Suture
- Keywords
- Polyglactin 910, Chlorhexidine diacetate, Antibacterial sutures, Third molar surgery, Split-mouth, Bacterial load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Diacetate-Coated Polyglactin 910 SutureDevice
Polyglactin 910 absorbable suture coated with chlorhexidine diacetate, used to close one extraction site after impacted lower third molar surgery.
Uncoated Polyglactin 910 SutureDevice
Standard uncoated Polyglactin 910 absorbable suture, used to close the other extraction site after impacted lower third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Diacetate-Coated Polyglactin 910 Suture | Experimental | The extraction site is closed with Polyglactin 910 sutures coated with chlorhexidine diacetate (CHX-DA). Receives: Device: Chlorhexidine Diacetate-Coated Polyglactin 910 Suture |
| Uncoated Polyglactin 910 Suture | Active comparator | The extraction site is closed with standard uncoated Polyglactin 910 sutures. Receives: Device: Uncoated Polyglactin 910 Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 3, 5, and 7
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).
Measured: Postoperative days 3, 5, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start20 Oct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- 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
- Model description
- Split-mouth design. Each participant undergoes extraction of two symmetrical impacted lower third molars. The two extraction sites within the same participant are randomly assigned to the two suture types (chlorhexidine diacetate-coated Polyglactin 910 versus uncoated Polyglactin 910), so each participant receives both interventions and serves as their own control.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pham Trung Dung, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794280
- Sponsor's protocol ID
- 3419/ĐHYD-HĐĐĐ
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on sharing individual participant data has not yet been made.
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 37782154Mohan 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