Chlorhexidine Diacetate-Coated Polyglactin 910 Suture
DevicePolyglactin 910 absorbable suture coated with chlorhexidine diacetate, used to close one extraction site after impacted lower third molar surgery.
NCT Number: NCT07794280
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.
Trial opening soon.
Get Notified18 year–35 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Postoperative days 3, 5, and 7
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 at the extraction site assessed using the IPR (Index) healing scale.
Contact information is provided by the study sponsor or research team.
University of Medicine and Pharmacy at Ho Chi Minh City
Other
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
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