Poly(Lactide-co-glycolide) SuturesNCT07498361
Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial.
A study testing Fast absorbable sutures application and Standard absorbable sutures application in people with Poly(Lactide-co-glycolide) Sutures and Suture Resorption, run by University of Padova, School of Dental Medicine at 1 site in Italy.
Trial summary
This study aims to compare slow-resorbing and fast-resorbing sutures used after the surgical extraction of lower third molars. Sutures are routinely placed after wisdom tooth removal to promote hemostasis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poly(Lactide-co-glycolide) Sutures, Suture Resorption, Third Molar Surgery
- What is being tested?
- Fast absorbable sutures application and Standard absorbable sutures application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non smoker patients
- clinical indication to third molar surgical removal
- patients who are able to express informed consent
Who cannot join
- smokers
- pregnant female
- subjects treated with medications that affect bone metabolism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Hospital Dental Clinic
Padua, Padua, 35100
Hospital Dental Clinic, 049 8218669, odontoiatria@aopd.veneto.it
About this study
This study aims to compare slow-resorbing and fast-resorbing sutures used after the surgical extraction of lower third molars. Sutures are routinely placed after wisdom tooth removal to promote hemostasis. Slow-resorbing and fast-resorbing sutures differ mainly in how long they remain in place, and fast-resorbing sutures often do not require removal. The study evaluates whether these two types of sutures differ in terms of microbiological contamination. Patient-reported inflammation, swelling, and postoperative discomfort will also be assessed.
Each participant will be randomly assigned to receive one of the two suture types. Only routine clinical procedures are involved. Participation includes several standard visits: initial medical and dental history collection with oral and radiographic examination; the surgical extraction of the lower third molar; suture removal at 7 days. No additional invasive procedures are required.
Read more
Participants will receive a daily diary to record pain levels and any pain medication taken during the first postoperative week. At the 7-day visit, wound healing will be evaluated and sutures will be removed, collected and anonymously analyzed by the University Microbiology Laboratory.
This study seeks to provide useful information about the clinical performance and microbiological behavior of different types of resorbable sutures commonly used in oral surgery, with the goal of improving patient care and postoperative outcomes.
Read the detailed description
This study investigates the use of slow-resorbing versus fast-resorbing sutures following the surgical extraction of lower third molars. Sutures are routinely placed after wisdom tooth removal to promote hemostasis. Fast-resorbing sutures often do not require removal, while slow-resorbing sutures typically remain in place longer. The aim of the study is to compare the two types of sutures in terms of microbiological contamination. Patient-reported inflammation, swelling, and overall discomfort will also be assessed.
Each participant will be randomly assigned to receive one of the two suture types. Only routine oral surgery procedures are included, and no additional invasive or non-routine interventions are planned. Participation involves several standard visits: an initial screening visit with medical and dental history collection, oral examination, plaque and bleeding assessment, and radiographic review; the surgical extraction of the lower third molar; suture removal after 7 days.
On the day of the procedure, participants will receive a daily questionnaire to record pain levels and any analgesic medication taken during the first postoperative week. After surgery, standard antibiotic and anti-inflammatory therapy will be prescribed.
At the 7-day visit, sutures will be removed. The removed sutures will be collected and anonymously sent to the University Microbiology Laboratory (UniPD) for analysis and the participant's questionnaire will be retrieved.
Participants are expected to follow all postoperative instructions and attend all scheduled visits, which are essential both for proper clinical follow-up and for participation in the study. Any complications such as pain or bleeding must be promptly reported to the dentist. The overall goal of the study is to better understand the clinical and microbiological behavior of commonly used resorbable sutures in oral surgery, ultimately aiming to improve patient care and postoperative outcomes.
- Being tested
- Fast absorbable sutures application, Standard absorbable sutures application
- Keywords
- poly(lactide-co-glycolide) sutures, third molar surgery, microbial biofilm, suture resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast absorbable sutures applicationDevice
Fast absorbable sutures application on experimental group
Standard absorbable sutures applicationDevice
Standard absorbable sutures application will be applied on control group
| Study group | Role | What they receive |
|---|---|---|
| Polysorb group | Active comparator | Standard absorbable sutures will be applied on these patients. Receives: Device: Standard absorbable sutures application |
| Velosorb group | Experimental | Fast absorbable sutures will be applied on these patients Receives: Device: Fast absorbable sutures application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological evaluation of the sutures
After seven days, one operator will remove the sutures and immediately place them in a sterile, pre-weighed tube containing 1 ml of Brain Heart Infusion broth (BHI, Thermo Fisher, Waltham, USA), avoiding external contamination. Samples will be immediately transported to the microbiology laboratory, weighed, vortexed, and seeded on blood agar (BA), anaerobe blood agar (CDC), chocolate agar (CA), and Mitis salivarius agar (MSA), under anaerobic and aerobic conditions at 37°C for 24 hours. The bacterial load will be quantified as colony-forming units per millilitre (CFU/ml) and normalised by the weight of the sample.
Measured: Evaluation will be conducted at the removal of the sutures (7 days after surgery)
Secondary outcomes (2)
Clinician evaluation
From the clinician's perspective, they will be required to report, on a VAS scale, the level of difficulty encountered during suture removal at 7 days post-surgery, which will be performed using sterile scissors and forceps. The Visual Analog Scale (VAS) is used with values ranging from 1 to 10, where 1 corresponds to the minimum value (minimal difficulty for the operator) and 10 corresponds to the maximum value (maximum difficulty for the operator), with 2-9 representing intermediate values.
Measured: Clinical evaluation will be collected at the removal of the sutures (7 days after surgery)
Patient reported outcomes
From the patient's perspective, a VAS (Visual Analogue Scale) will be used to subjectively assess the discomfort during the 7 days in which the sutures remain in the mouth, as well as the pain associated with their removal after 7 days. The Visual Analog Scale (VAS) is used with values ranging from 1 to 10, where 1 corresponds to the minimum value (minimal discomfort for the patient) and 10 corresponds to the maximum value (maximum discomfort for the patient), with 2-9 representing intermediate values.
Measured: These parameters will be collected 7 days after surgery (at sutures removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start3 Dec 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
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 Poly(Lactide-co-glycolide) SuturesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova, School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Sivolella, University of Padova, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498361
- Sponsor's protocol ID
- AOP3206
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asher R, Chacartchi T, Tandlich M, Shapira L, Polak D. Microbial accumulation on different suture materials following oral surgery: a randomized controlled study. Clin Oral Investig. 2019 Feb;23(2):559-565. doi: 10.1007/s00784-018-2476-0. Epub 2018 May 2.
PubMed 29717362
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07498361
- Acronym / sponsor ID
- AOP3206
- Keywords
- poly(lactide-co-glycolide) sutures, third molar surgery, microbial biofilm, suture resorption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of Padova, School of Dental MedicineUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 27 Mar 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 study aims to compare slow-resorbing and fast-resorbing sutures used after the surgical extraction of lower third molars. Sutures are routinely placed after wisdom tooth removal to promote hemostasis. Slow-resorbing and fast-resorbing sutures differ mainly in how long they remain in place, and fast-resorbing sutures often do not require removal. The study evaluates whether these two types of sutures differ in terms of microbiological contamination. Patient-reported inflammation, swelling, and postoperative discomfort will also be assessed.
Each participant will be randomly assigned to receive one of the two suture types. Only routine clinical procedures are involved. Participation includes several standard visits: initial medical and dental history collection with oral and radiographic examination; the surgical extraction of the lower third molar; suture removal at 7 days. No additional invasive procedures are required.
Participants will receive a daily diary to record pain levels and any pain medication taken during the first postoperative week. At the 7-day visit, wound healing will be evaluated and sutures will be removed, collected and anonymously analyzed by the University Microbiology Laboratory.
This study seeks to provide useful information about the clinical performance and microbiological behavior of different types of resorbable sutures commonly used in oral surgery, with the goal of improving patient care and postoperative outcomes.
Detailed description
This study investigates the use of slow-resorbing versus fast-resorbing sutures following the surgical extraction of lower third molars. Sutures are routinely placed after wisdom tooth removal to promote hemostasis. Fast-resorbing sutures often do not require removal, while slow-resorbing sutures typically remain in place longer. The aim of the study is to compare the two types of sutures in terms of microbiological contamination. Patient-reported inflammation, swelling, and overall discomfort will also be assessed.
Each participant will be randomly assigned to receive one of the two suture types. Only routine oral surgery procedures are included, and no additional invasive or non-routine interventions are planned. Participation involves several standard visits: an initial screening visit with medical and dental history collection, oral examination, plaque and bleeding assessment, and radiographic review; the surgical extraction of the lower third molar; suture removal after 7 days.
On the day of the procedure, participants will receive a daily questionnaire to record pain levels and any analgesic medication taken during the first postoperative week. After surgery, standard antibiotic and anti-inflammatory therapy will be prescribed.
At the 7-day visit, sutures will be removed. The removed sutures will be collected and anonymously sent to the University Microbiology Laboratory (UniPD) for analysis and the participant's questionnaire will be retrieved.
Participants are expected to follow all postoperative instructions and attend all scheduled visits, which are essential both for proper clinical follow-up and for participation in the study. Any complications such as pain or bleeding must be promptly reported to the dentist. The overall goal of the study is to better understand the clinical and microbiological behavior of commonly used resorbable sutures in oral surgery, ultimately aiming to improve patient care and postoperative outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polysorb group | Active comparator | Device: Standard absorbable sutures applicationStandard absorbable sutures will be applied on these patients. |
| Velosorb group | Experimental | Device: Fast absorbable sutures applicationFast absorbable sutures will be applied on these patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non smoker patients
- clinical indication to third molar surgical removal
- patients who are able to express informed consent
Key exclusion criteria (3 listed)
- smokers
- pregnant female
- subjects treated with medications that affect bone metabolism
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 |
|---|---|---|
| Fast absorbable sutures applicationFast absorbable sutures application on experimental group | Device | Velosorb group |
| Standard absorbable sutures applicationStandard absorbable sutures application will be applied on control group | Device | Polysorb group |
Primary outcome
Microbiological evaluation of the sutures
Time frame: Evaluation will be conducted at the removal of the sutures (7 days after surgery)
After seven days, one operator will remove the sutures and immediately place them in a sterile, pre-weighed tube containing 1 ml of Brain Heart Infusion broth (BHI, Thermo Fisher, Waltham, USA), avoiding external contamination. Samples will be immediately transported to the microbiology laboratory, weighed, vortexed, and seeded on blood agar (BA), anaerobe blood agar (CDC), chocolate agar (CA), and Mitis salivarius agar (MSA), under anaerobic and aerobic conditions at 37°C for 24 hours. The bacterial load will be quantified as colony-forming units per millilitre (CFU/ml) and normalised by the weight of the sample.
2 secondary outcomes
Clinician evaluation
Time frame: Clinical evaluation will be collected at the removal of the sutures (7 days after surgery)
Patient reported outcomes
Time frame: These parameters will be collected 7 days after surgery (at sutures removal)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 29717362Asher R, Chacartchi T, Tandlich M, Shapira L, Polak D. Microbial accumulation on different suture materials following oral surgery: a randomized controlled study. Clin Oral Investig. 2019 Feb;23(2):559-565. doi: 10.1007/s00784-018-2476-0. Epub 2018 May 2.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast absorbable sutures application and Standard absorbable sutures application in people with Poly(Lactide-co-glycolide) Sutures and Suture Resorption, run by University of Padova, School of Dental Medicine at 1 site in Italy.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Apr 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Sivolella, DDS (049 821 8669, stefano.sivolella@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological evaluation of the sutures (time frame: Evaluation will be conducted at the removal of the sutures (7 days after surgery)). 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 NCT07498361, 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 6 Apr 2026.