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NCT Number: NCT07498361

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Dental Clinic

Padua, 35100, Italy

Location status: Recruiting

Location contact

Hospital Dental Clinic

CONTACT

[email protected]

049 8218669

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fast absorbable sutures application

Device

Fast absorbable sutures application on experimental group

Standard absorbable sutures application

Device

Standard absorbable sutures application will be applied on control group

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinician evaluation

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

    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.

  2. Patient reported outcomes

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Sivolella, DDS

CONTACT

[email protected]

049 821 8669

Sponsors and collaborators

Lead sponsor

University of Padova, School of Dental Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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