Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial.

NCT07498361 | Recruiting DMC

• 1 other identifier: AOP3206
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Poly(Lactide-co-glycolide) Sutures; Suture Resorption; Third Molar Surgery

Keywords

poly(lactide-co-glycolide) sutures; third molar surgery; microbial biofilm; suture resorption

Outcome Measures

Primary Outcomes (1)

• 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.

  Evaluation will be conducted at the removal of the sutures (7 days after surgery)

Secondary Outcomes (2)

• Clinician evaluation

  Clinical evaluation will be collected at the removal of the sutures (7 days after surgery)

• Patient reported outcomes

  These parameters will be collected 7 days after surgery (at sutures removal)

Study Arms (2)

Polysorb group

ACTIVE COMPARATOR

Standard absorbable sutures will be applied on these patients.

Device: Standard absorbable sutures application

Velosorb group

EXPERIMENTAL

Fast absorbable sutures will be applied on these patients

Device: Fast absorbable sutures application

Interventions

Fast absorbable sutures application DEVICE

Fast absorbable sutures application on experimental group

Velosorb group

Standard absorbable sutures application DEVICE

Standard absorbable sutures application will be applied on control group

Polysorb group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non smoker patients
• clinical indication to third molar surgical removal
• patients who are able to express informed consent

You may not qualify if:

• smokers
• pregnant female
• subjects treated with medications that affect bone metabolism

Sponsors & Collaborators

• University of Padova, School of Dental Medicine: lead

Study Sites (1)

Hospital Dental Clinic

Padua, Padua, 35100, Italy

RECRUITING

Related Publications (1)

• R. Asher, T. Chacartchi, M. Tandlich, L. Shapira, and D. Polak, "Microbial accumulation on different suture materials following oral surgery: a randomized controlled study.," Clin. Oral Investig., vol. 23, no. 2, pp. 559-565, Feb. 2019.

  BACKGROUND

Central Study Contacts

Stefano Sivolella, DDS

CONTACT

049 821 8669; stefano.sivolella@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: March 27, 2026
• Study Start: December 3, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)