Third Molars ExtractionNCT07175818
Cold Plasma-Treated Sutures in Third Molar Surgery: Effects on Outcomes
A study testing Silk suture only, PTFE suture only and Silk Suture + Cold athmospheric Plasma in people with Third Molars Extraction and Suture Materials, run by Izzet Acikan at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Third Molars Extraction, Suture Materials
- What is being tested?
- Silk suture only, PTFE suture only and Silk Suture + Cold athmospheric Plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2025to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old and had no acute pericoronal infection
Who cannot join
- Individuals with systemic con-ditions such as diabetes mellitus, immunodeficiency, bleeding disorders, dyspepsia, or those classified as heavy smokers (over 10 cigarettes daily)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University, Faculty of Dentistry
Kahramanmaraş
About this study
Official title: Effects of Cold Plasma Systems Applied to PTFE and Silk Su-tures Used in Impacted Lower Third Molar Surgery on Post-operative Sequelae and Quality of Life
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.
- Conditions
- Third Molars Extraction, Suture Materials
- Being tested
- Silk suture only, PTFE suture only, Silk Suture + Cold athmospheric Plasma, PTFE Suture + Cold athmospheric Plasma, Silk Suture + Cold athmospheric argon Plasma
- Keywords
- third molar, Cold Plasma, PTFE, Silk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk suture onlyProcedure or surgery
After third molar extraction, the surgical wound will be closed using silk sutures without plasma application.
PTFE suture onlyProcedure or surgery
After third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.
Silk Suture + Cold athmospheric PlasmaProcedure or surgery
After third molar extraction, silk sutures will be exposed to cold atmospheric plasma before being used for wound closure.
PTFE Suture + Cold athmospheric PlasmaProcedure or surgery
After third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application.
Silk Suture + Cold athmospheric argon PlasmaProcedure or surgery
After third molar extraction, silk sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.
PTFE Suture + Cold athmospheric argon PlasmaProcedure or surgery
After third molar extraction, PTFE sutures will be exposed to cold atmospheric argon plasma before being used for wound closure.
| Study group | Role | What they receive |
|---|---|---|
| silk suture only | Active comparator | The group in which only silk sutures will be used for wound closure after third molar extraction. Receives: Procedure: Silk suture only |
| PTFE suture only | Active comparator | The group in which only PTFE sutures will be used for wound closure after third molar extraction. Receives: Procedure: PTFE suture only |
| silk suture and CAP | Experimental | The group in which cold atmospheric plasma is applied to silk sutures before wound closure with silk sutures after third molar extraction. Receives: Procedure: Silk Suture + Cold athmospheric Plasma |
| PTFE suture and CAP | Experimental | The group in which cold atmospheric plasma is applied to PTFE sutures before wound closure with PTFE sutures after third molar extraction. Receives: Procedure: PTFE Suture + Cold athmospheric Plasma |
| silk suture and CAP-Ar | Experimental | The group in which cold atmospheric argon plasma is applied to silk sutures before wound closure with silk sutures after third molar extraction. Receives: Procedure: Silk Suture + Cold athmospheric argon Plasma |
| PTFE suture and CAP-Ar | Experimental | The group in which cold atmospheric argon plasma is applied to PTFE sutures before wound closure with PTFE sutures after third molar extraction. Receives: Procedure: PTFE Suture + Cold athmospheric argon Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assessment
The patients' pain levels were evaluated using a 10-unit Visual Analog Scale (VAS). The patients were given a form on which they could mark the pain they felt as a score between 0 (no pain) and 10 (the most severe pain) at the following time points: 20 minutes before local anesthesia administration, and on postoperative day 1, day 2, day 3, day 4, day 5, day 6, and day 7. After completing these forms, the patients returned them at the end of the 7th day.
Measured: Preoperative 20 minutes before local anesthesia administration, 1st. day, 2nd. day, 3rd. day, 4th. day, 5th. day, 6th. day, 7th. day.
Facial Swelling Assessment
Facial swelling was assessed by performing three-dimensional (3D) facial scans at three different time points: prior to surgery (T0), on the second postoperative day (T1), and on the seventh postoperative day (T2). All scans were obtained in the same clinical room under consistent lighting conditions. For image acquisition, the Qlone appli-cation (EyeCue Vision Technologies LTD.), compatible with iOS devices (iPhone 14, Apple Inc., CA, USA), was utilized, offering a guided face-scanning process. Upon completion, each scan was converted into an STL file, which was subsequently transferred to the 3D Slicer software. The paired scans were then superimposed, and volumetric differences were calculated.
Measured: prior to surgery, on the second postoperative day, and on the seventh postoperative day
Mouth Opening Assessment
Interincisal mouth opening was measured both before and after surgery using a standard monoblock caliper. During the assessment, participants were seated upright with the orbitomeatal plane aligned parallel to the ground. The maximum unassisted midline in-terincisal distance was recorded in millimeters (mm) at three time points.
Measured: prior to the operation, on the second postoperative day, and on the seventh postoperative day
Quality of life Assessment
Quality of life was evaluated before and after surgery using the OHIP-14 questionnaire. Postoperative assessments were carried out on the preoperatively, 2nd, and 7th days following the procedure. Each question was rated on a 4-point scale: 1 = "never," 2 = "sometimes," 3 = "fairly often," and 4 = "very often." The possible total score ranged from 0 to 56, with higher scores reflecting greater impairment in quality of life.
Measured: preoperatively, 2nd, and 7th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start24 Mar 2025
- Primary completion30 May 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Third Molars ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izzet Acikan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Izzet Acikan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175818
- Sponsor's protocol ID
- HRÜ/25.04.42
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the results reported in the article, including anonymized demographic information, postoperative pain scores, swelling measurements, mouth opening values, and quality of life questionnaire results, will be shared. A data dictionary describing each variable will also be provided to ensure proper interpretation. Data will be made available upon reasonable request from qualified researchers after publication of the main results.
Publications
Ercan UK, Ibis F, Dikyol C, Horzum N, Karaman O, Yildirim C, Cukur E, Demirci EA. Prevention of bacterial colonization on non-thermal atmospheric plasma treated surgical sutures for control and prevention of surgical site infections. PLoS One. 2018 Sep 5;13(9):e0202703. doi: 10.1371/journal.pone.0202703. eCollection 2018.
PubMed 30183745
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cold Plasma Systems Applied to PTFE and Silk Su-tures Used in Impacted Lower Third Molar Surgery on Post-operative Sequelae and Quality of Life
- ClinicalTrials.gov ID
- NCT07175818
- Acronym / sponsor ID
- HRÜ/25.04.42
- Conditions
- Third Molars Extraction, Suture Materials
- Keywords
- third molar, Cold Plasma, PTFE, Silk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Izzet AcikanUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| silk suture only | Active comparator | Procedure: Silk suture onlyThe group in which only silk sutures will be used for wound closure after third molar extraction. |
| PTFE suture only | Active comparator | Procedure: PTFE suture onlyThe group in which only PTFE sutures will be used for wound closure after third molar extraction. |
| silk suture and CAP | Experimental | Procedure: Silk Suture + Cold athmospheric PlasmaThe group in which cold atmospheric plasma is applied to silk sutures before wound closure with silk sutures after third molar extraction. |
| PTFE suture and CAP | Experimental | Procedure: PTFE Suture + Cold athmospheric PlasmaThe group in which cold atmospheric plasma is applied to PTFE sutures before wound closure with PTFE sutures after third molar extraction. |
| silk suture and CAP-Ar | Experimental | Procedure: Silk Suture + Cold athmospheric argon PlasmaThe group in which cold atmospheric argon plasma is applied to silk sutures before wound closure with silk sutures after third molar extraction. |
| PTFE suture and CAP-Ar | Experimental | Procedure: PTFE Suture + Cold athmospheric argon PlasmaThe group in which cold atmospheric argon plasma is applied to PTFE sutures before wound closure with PTFE sutures after third molar extraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least 18 years old and had no acute pericoronal infection
Key exclusion criteria (1 listed)
- Individuals with systemic con-ditions such as diabetes mellitus, immunodeficiency, bleeding disorders, dyspepsia, or those classified as heavy smokers (over 10 cigarettes daily)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silk suture onlyAfter third molar extraction, the surgical wound will be closed using silk sutures without plasma application. | Procedure or surgery | silk suture only |
| PTFE suture onlyAfter third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application. | Procedure or surgery | PTFE suture only |
| Silk Suture + Cold athmospheric PlasmaAfter third molar extraction, silk sutures will be exposed to cold atmospheric plasma before being used for wound closure. | Procedure or surgery | silk suture and CAP |
| PTFE Suture + Cold athmospheric PlasmaAfter third molar extraction, the surgical wound will be closed using PTFE sutures without plasma application. | Procedure or surgery | PTFE suture and CAP |
| Silk Suture + Cold athmospheric argon PlasmaAfter third molar extraction, silk sutures will be exposed to cold atmospheric argon plasma before being used for wound closure. | Procedure or surgery | silk suture and CAP-Ar |
| PTFE Suture + Cold athmospheric argon PlasmaAfter third molar extraction, PTFE sutures will be exposed to cold atmospheric argon plasma before being used for wound closure. | Procedure or surgery | PTFE suture and CAP-Ar |
Primary outcome
Postoperative Pain Assessment
Time frame: Preoperative 20 minutes before local anesthesia administration, 1st. day, 2nd. day, 3rd. day, 4th. day, 5th. day, 6th. day, 7th. day.
The patients' pain levels were evaluated using a 10-unit Visual Analog Scale (VAS). The patients were given a form on which they could mark the pain they felt as a score between 0 (no pain) and 10 (the most severe pain) at the following time points: 20 minutes before local anesthesia administration, and on postoperative day 1, day 2, day 3, day 4, day 5, day 6, and day 7. After completing these forms, the patients returned them at the end of the 7th day.
Facial Swelling Assessment
Time frame: prior to surgery, on the second postoperative day, and on the seventh postoperative day
Facial swelling was assessed by performing three-dimensional (3D) facial scans at three different time points: prior to surgery (T0), on the second postoperative day (T1), and on the seventh postoperative day (T2). All scans were obtained in the same clinical room under consistent lighting conditions. For image acquisition, the Qlone appli-cation (EyeCue Vision Technologies LTD.), compatible with iOS devices (iPhone 14, Apple Inc., CA, USA), was utilized, offering a guided face-scanning process. Upon completion, each scan was converted into an STL file, which was subsequently transferred to the 3D Slicer software. The paired scans were then superimposed, and volumetric differences were calculated.
Mouth Opening Assessment
Time frame: prior to the operation, on the second postoperative day, and on the seventh postoperative day
Interincisal mouth opening was measured both before and after surgery using a standard monoblock caliper. During the assessment, participants were seated upright with the orbitomeatal plane aligned parallel to the ground. The maximum unassisted midline in-terincisal distance was recorded in millimeters (mm) at three time points.
Quality of life Assessment
Time frame: preoperatively, 2nd, and 7th days
Quality of life was evaluated before and after surgery using the OHIP-14 questionnaire. Postoperative assessments were carried out on the preoperatively, 2nd, and 7th days following the procedure. Each question was rated on a 4-point scale: 1 = "never," 2 = "sometimes," 3 = "fairly often," and 4 = "very often." The possible total score ranged from 0 to 56, with higher scores reflecting greater impairment in quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Results publication: PubMed 30183745Ercan UK, Ibis F, Dikyol C, Horzum N, Karaman O, Yildirim C, Cukur E, Demirci EA. Prevention of bacterial colonization on non-thermal atmospheric plasma treated surgical sutures for control and prevention of surgical site infections. PLoS One. 2018 Sep 5;13(9):e0202703. doi: 10.1371/journal.pone.0202703. eCollection 2018.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the results reported in the article, including anonymized demographic information, postoperative pain scores, swelling measurements, mouth opening values, and quality of life questionnaire results, will be shared. A data dictionary describing each variable will also be provided to ensure proper interpretation. Data will be made available upon reasonable request from qualified researchers after publication of the main results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silk suture only, PTFE suture only and Silk Suture + Cold athmospheric Plasma in people with Third Molars Extraction and Suture Materials, run by Izzet Acikan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Assessment (time frame: Preoperative 20 minutes before local anesthesia administration, 1st. day, 2nd. day, 3rd. day, 4th. day, 5th. day, 6th. day, 7th. day.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.