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
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.
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.
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.
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Exclusion Criteria:
The extraction site is closed with Polyglactin 910 sutures coated with chlorhexidine diacetate (CHX-DA).
Device: Chlorhexidine Diacetate-Coated Polyglactin 910 Suture
The extraction site is closed with standard uncoated Polyglactin 910 sutures.
Device: Uncoated Polyglactin 910 Suture
Polyglactin 910 absorbable suture coated with chlorhexidine diacetate, used to close one extraction site after impacted lower third molar surgery.
Standard uncoated Polyglactin 910 absorbable suture, used to close the other extraction site after impacted lower third molar surgery.
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
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
No study locations are listed for this record.
Plan to share: Undecided — A decision on sharing individual participant data has not yet been made.
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 ↗
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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