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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-24

Study Completion Date

2025-06-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Third Molars Extraction Suture Materials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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silk suture only

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

Group Type ACTIVE_COMPARATOR

Silk suture only

Intervention Type PROCEDURE

After third molar extraction, the surgical wound will be closed using silk sutures without plasma application.

PTFE suture only

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

Group Type ACTIVE_COMPARATOR

PTFE suture only

Intervention Type PROCEDURE

After third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.

silk suture and CAP

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

Group Type EXPERIMENTAL

Silk Suture + Cold athmospheric Plasma

Intervention Type PROCEDURE

After third molar extraction, silk sutures will be exposed to cold atmospheric plasma before being used for wound closure.

PTFE suture and CAP

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

Group Type EXPERIMENTAL

PTFE Suture + Cold athmospheric Plasma

Intervention Type PROCEDURE

After third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.

silk suture and CAP-Ar

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

Group Type EXPERIMENTAL

Silk Suture + Cold athmospheric argon Plasma

Intervention Type PROCEDURE

After third molar extraction, silk sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.

PTFE suture and CAP-Ar

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

Group Type EXPERIMENTAL

PTFE Suture + Cold athmospheric argon Plasma

Intervention Type PROCEDURE

After third molar extraction, PTFE sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.

Interventions

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Silk suture only

After third molar extraction, the surgical wound will be closed using silk sutures without plasma application.

Intervention Type PROCEDURE

PTFE suture only

After third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.

Intervention Type PROCEDURE

Silk Suture + Cold athmospheric Plasma

After third molar extraction, silk sutures will be exposed to cold atmospheric plasma before being used for wound closure.

Intervention Type PROCEDURE

PTFE Suture + Cold athmospheric Plasma

After third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.

Intervention Type PROCEDURE

Silk Suture + Cold athmospheric argon Plasma

After third molar extraction, silk sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.

Intervention Type PROCEDURE

PTFE Suture + Cold athmospheric argon Plasma

After third molar extraction, PTFE sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No