Cold Plasma-Treated Sutures in Third Molar Surgery: Effects on Outcomes

Izzet Acikan

Status: Completed

Conditions: Suture Materials; Third Molars Extraction

Treatments: Procedure: PTFE Suture + Cold athmospheric argon Plasma; Procedure: Silk Suture + Cold athmospheric Plasma; Procedure: Silk Suture + Cold athmospheric argon Plasma; Procedure: Silk suture only; Procedure: PTFE Suture + Cold athmospheric Plasma; Procedure: PTFE suture only

Study type: Interventional

Funder types: Other

Identifiers

NCT07175818

HRÜ/25.04.42

Details and patient eligibility

About

This study aims to compare the effectiveness of two types of surgical suture materials, silk and polytetrafluoroethylene (PTFE), used alone and in combination with cold atmospheric plasma systems, on postoperative outcomes such as pain, facial swelling, and limitation of mouth opening following mandibular third molar surgery. Written informed consent will be obtained from all volunteers prior to participation. For all groups, the surgical procedures will be performed on an outpatient basis under local anesthesia (2% lidocaine with 1:100,000 epinephrine) by a single surgeon. After achieving deep local anesthesia by blocking the inferior alveolar, buccal, and lingual nerves, the incision will be made using a modified envelope flap. Bone osteotomy will be performed under copious irrigation with sterile saline, using a high-speed straight surgical handpiece (20,000-40,000 rpm) and a #10 surgical round bur. After successful extraction of the teeth, bone margins will be appropriately smoothed, and the surgical site will be irrigated thoroughly with saline. The mucoperiosteal flap will then be closed with sutures according to the group criteria. For groups assigned to plasma application, plasma will be applied to the surface of the sutures. Pre- and postoperative evaluations will be conducted for all patients regarding facial swelling, limitation of mouth opening, and pain, using the same techniques. Assessment of swelling and mouth opening limitation will also be performed by the surgeon. Quality of life will be evaluated preoperatively and postoperatively for all participants. Follow-up examinations will be performed preoperatively, on the 2nd postoperative day, and on the 7th postoperative day. At these time points, facial scans will be recorded using the Qlone application on an iPhone 14, and STL files will be generated.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 18 years old and had no acute pericoronal infection

Exclusion criteria

• Individuals with systemic con-ditions such as diabetes mellitus, immunodeficiency, bleeding disorders, dyspepsia, or those classified as heavy smokers (over 10 cigarettes daily)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 6 patient groups

silk suture only

Active Comparator group

Description:

The group in which only silk sutures will be used for wound closure after third molar extraction.

Treatment:

Procedure: Silk suture only

PTFE suture only

Active Comparator group

Description:

The group in which only PTFE sutures will be used for wound closure after third molar extraction.

Treatment:

Procedure: PTFE suture only

silk suture and CAP

Experimental group

Description:

The group in which cold atmospheric plasma is applied to silk sutures before wound closure with silk sutures after third molar extraction.

Treatment:

Procedure: Silk Suture + Cold athmospheric Plasma

PTFE suture and CAP

Experimental group

Description:

The group in which cold atmospheric plasma is applied to PTFE sutures before wound closure with PTFE sutures after third molar extraction.

Treatment:

Procedure: PTFE Suture + Cold athmospheric Plasma

silk suture and CAP-Ar

Experimental group

Description:

The group in which cold atmospheric argon plasma is applied to silk sutures before wound closure with silk sutures after third molar extraction.

Treatment:

Procedure: Silk Suture + Cold athmospheric argon Plasma

PTFE suture and CAP-Ar

Experimental group

Description:

The group in which cold atmospheric argon plasma is applied to PTFE sutures before wound closure with PTFE sutures after third molar extraction.

Treatment:

Procedure: PTFE Suture + Cold athmospheric argon Plasma