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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Padova, School of Dental Medicine

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

non smoker patients

clinical indication to third molar surgical removal

patients who are able to express informed consent

Disqualifiers

smokers

pregnant female

subjects treated with medications that affect bone metabolism

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: Polysorb groupActive comparator 1 intervention
Group B: Velosorb groupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Clinical evaluation will be collected at the removal of the sutures (7 days after surgery)
2

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.

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

Other outcomes

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