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

NCT07794280 | Not Yet Recruiting

• 1 other identifier: 3419/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Impacted Third Molar Tooth; Surgical Wound Healing

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Postoperative days 3, 5, and 7

• Soft Tissue Healing

  Soft tissue healing at the extraction site assessed using the IPR (Index) healing scale.

  Postoperative days 3, 5, and 7

Study Arms (2)

Chlorhexidine Diacetate-Coated Polyglactin 910 Suture

EXPERIMENTAL

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

Device: Chlorhexidine Diacetate-Coated Polyglactin 910 Suture

Uncoated Polyglactin 910 Suture

ACTIVE COMPARATOR

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

Device: Uncoated Polyglactin 910 Suture

Interventions

Chlorhexidine Diacetate-Coated Polyglactin 910 Suture DEVICE

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

Chlorhexidine Diacetate-Coated Polyglactin 910 Suture

Uncoated Polyglactin 910 Suture DEVICE

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

Uncoated Polyglactin 910 Suture

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Related Publications (2)

• 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.

  PMID: 37782154 RESULT

• 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.

  PMID: 33071503 RESULT

Central Study Contacts

Dung Pham, DDS

CONTACT

+84 852 777 319; trungdung.yds17@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Allocation of each extraction site to a suture type was performed by an independent person who conducted the randomization draw and was the only party aware of the group assignment. The two suture types are visually similar, so participants, the surgeon, and the outcome assessors remained unaware of which suture was placed at each site throughout the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08