PeriodontitisNCT07852520
Breaking Force of Periodontal Suture Materials After Intraoral Exposure
A study testing Silk Suture 3-0, Silk Suture 4-0 and Polypropylene Suture 3-0 in people with Periodontitis, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, six-arm randomized clinical retrieval study was designed to compare the maximum breaking force of three commonly used non-absorbable periodontal suture materials-silk, polypropylene, and polytetrafluoroethylene (PTFE)-in sizes 3-0 and 4-0 before clinical use and after 7 days of intraoral exposure… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Silk Suture 3-0, Silk Suture 4-0 and Polypropylene Suture 3-0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 15 Oct 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of Stage III grade B periodontitis
- Completion of non-surgical periodontal therapy
- Indication for periodontal flap surgery in the maxillary or mandibular posterior region with probing pocket depth ≥5 mm
- Presence of three adjacent teeth with two- and/or three-wall intrabony defects
- Bleeding score ≤20%
Who cannot join
- Systemic diseases affecting healing
- Pregnancy or lactation
- Antibiotic use within the preceding period
- Use of medications affecting periodontal healing
- Smoking according to the prespecified study threshold
- Previous surgery at the study site
- Inability to attend the postoperative day-7 visit
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Dentistry
Adana
About this study
Official title: Maximum Breaking Force of Periodontal Suture Materials Before and After 7 Days of Intraoral Exposure: A Six-Arm Randomized Clinical Retrieval Study With Laboratory Mechanical Testing
This prospective, six-arm randomized clinical retrieval study was designed to compare the maximum breaking force of three commonly used non-absorbable periodontal suture materials-silk, polypropylene, and polytetrafluoroethylene (PTFE)-in sizes 3-0 and 4-0 before clinical use and after 7 days of intraoral exposure following periodontal flap surgery. The study included 120 participants with Stage III Grade B periodontitis requiring periodontal flap surgery. Participants were randomly allocated in a 1:1:1:1:1:1 ratio to one of six suture material-diameter groups: silk 3-0, silk 4-0, polypropylene 3-0, polypropylene 4-0, PTFE 3-0, or PTFE 4-0. Sutures were retrieved on postoperative day 7 and subjected to laboratory mechanical testing. Maximum breaking force was measured using a universal testing machine and compared with independent unused Day-0 specimens of the corresponding material and diameter. The study aimed to determine the effects of suture material, USP diameter, and exposure condition on maximum breaking force.
- Conditions
- Periodontitis
- Being tested
- Silk Suture 3-0, Silk Suture 4-0, Polypropylene Suture 3-0, Polypropylene Suture 4-0, PTFE Suture 3-0
- Keywords
- Periodontal Flap Surgery, Suture Materials
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk Suture 3-0Device
Non-absorbable 3-0 silk suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force.
Silk Suture 4-0Device
Non-absorbable 4-0 silk suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force.
Polypropylene Suture 3-0Device
Non-absorbable 3-0 polypropylene suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force.
Polypropylene Suture 4-0Device
Non-absorbable 4-0 polypropylene suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force.
PTFE Suture 3-0Device
Non-absorbable 3-0 PTFE suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force.
PTFE Suture 4-0Device
Non-absorbable 4-0 PTFE suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force.
| Study group | Role | What they receive |
|---|---|---|
| SİLK 3-0 | Experimental | Participants underwent periodontal flap surgery with wound closure using 3-0 silk sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. Receives: Device: Silk Suture 3-0 |
| SİLK 4-0 | Experimental | Participants underwent periodontal flap surgery with wound closure using 4-0 silk sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. Receives: Device: Silk Suture 4-0 |
| POLYPROPYLENE 3-0 | Experimental | Participants underwent periodontal flap surgery with wound closure using 3-0 polypropylene sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. Receives: Device: Polypropylene Suture 3-0 |
| POLYPROPYLENE 4-0 | Experimental | Participants underwent periodontal flap surgery with wound closure using 4-0 polypropylene sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. Receives: Device: Polypropylene Suture 4-0 |
| PTFE 3-0 | Experimental | Participants underwent periodontal flap surgery with wound closure using 3-0 PTFE sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. Receives: Device: PTFE Suture 3-0 |
| PTFE 4-0 | Experimental | Participants underwent periodontal flap surgery with wound closure using 4-0 PTFE sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. Receives: Device: PTFE Suture 4-0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Breaking Force of Retrieved Sutures
Measured: Postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 May 2025
- Primary completion1 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BAHAR ALKAYA, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852520
- Sponsor's protocol ID
- TDH-2025-17774
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximum Breaking Force of Periodontal Suture Materials Before and After 7 Days of Intraoral Exposure: A Six-Arm Randomized Clinical Retrieval Study With Laboratory Mechanical Testing
- ClinicalTrials.gov ID
- NCT07852520
- Acronym / sponsor ID
- TDH-2025-17774
- Conditions
- Periodontitis
- Keywords
- Periodontal Flap Surgery, Suture Materials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 1 Oct 2026 (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 prospective, six-arm randomized clinical retrieval study was designed to compare the maximum breaking force of three commonly used non-absorbable periodontal suture materials-silk, polypropylene, and polytetrafluoroethylene (PTFE)-in sizes 3-0 and 4-0 before clinical use and after 7 days of intraoral exposure following periodontal flap surgery. The study included 120 participants with Stage III Grade B periodontitis requiring periodontal flap surgery. Participants were randomly allocated in a 1:1:1:1:1:1 ratio to one of six suture material-diameter groups: silk 3-0, silk 4-0, polypropylene 3-0, polypropylene 4-0, PTFE 3-0, or PTFE 4-0. Sutures were retrieved on postoperative day 7 and subjected to laboratory mechanical testing. Maximum breaking force was measured using a universal testing machine and compared with independent unused Day-0 specimens of the corresponding material and diameter. The study aimed to determine the effects of suture material, USP diameter, and exposure condition on maximum breaking force.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SİLK 3-0 | Experimental | Device: Silk Suture 3-0Participants underwent periodontal flap surgery with wound closure using 3-0 silk sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. |
| SİLK 4-0 | Experimental | Device: Silk Suture 4-0Participants underwent periodontal flap surgery with wound closure using 4-0 silk sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. |
| POLYPROPYLENE 3-0 | Experimental | Device: Polypropylene Suture 3-0Participants underwent periodontal flap surgery with wound closure using 3-0 polypropylene sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. |
| POLYPROPYLENE 4-0 | Experimental | Device: Polypropylene Suture 4-0Participants underwent periodontal flap surgery with wound closure using 4-0 polypropylene sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. |
| PTFE 3-0 | Experimental | Device: PTFE Suture 3-0Participants underwent periodontal flap surgery with wound closure using 3-0 PTFE sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. |
| PTFE 4-0 | Experimental | Device: PTFE Suture 4-0Participants underwent periodontal flap surgery with wound closure using 4-0 PTFE sutures. Sutures were retrieved on postoperative day 7 for mechanical testing of maximum breaking force. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Diagnosis of Stage III grade B periodontitis
- Completion of non-surgical periodontal therapy
- Indication for periodontal flap surgery in the maxillary or mandibular posterior region with probing pocket depth ≥5 mm
- Presence of three adjacent teeth with two- and/or three-wall intrabony defects
Key exclusion criteria (7 listed)
- Systemic diseases affecting healing
- Pregnancy or lactation
- Antibiotic use within the preceding period
- Use of medications affecting periodontal healing
- Smoking according to the prespecified study threshold
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 3-0Non-absorbable 3-0 silk suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force. | Device | SİLK 3-0 |
| Silk Suture 4-0Non-absorbable 4-0 silk suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force. | Device | SİLK 4-0 |
| Polypropylene Suture 3-0Non-absorbable 3-0 polypropylene suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force. | Device | POLYPROPYLENE 3-0 |
| Polypropylene Suture 4-0Non-absorbable 4-0 polypropylene suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force. | Device | POLYPROPYLENE 4-0 |
| PTFE Suture 3-0Non-absorbable 3-0 PTFE suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force. | Device | PTFE 3-0 |
| PTFE Suture 4-0Non-absorbable 4-0 PTFE suture used for wound closure following periodontal flap surgery. The suture was retrieved on postoperative day 7 and subjected to mechanical testing for maximum breaking force. | Device | PTFE 4-0 |
Primary outcome
Maximum Breaking Force of Retrieved Sutures
Time frame: Postoperative day 7
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 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 3-0, Silk Suture 4-0 and Polypropylene Suture 3-0 in people with Periodontitis, run by Cukurova University 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 6 inclusion and 7 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 6 Oct 2026. 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?
Maximum Breaking Force of Retrieved Sutures (time frame: Postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.