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.
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
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
Crossover
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.
Uncoated Polyglactin 910 Suture
DeviceStandard 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.
Soft Tissue Healing
Soft tissue healing at the extraction site assessed using the IPR (Index) healing scale.
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