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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Fast absorbable sutures application
  Fast absorbable sutures application on experimental group
• Устройство Standard absorbable sutures application
  Standard absorbable sutures application will be applied on control group

Первичные конечные точки

• Microbiological evaluation of the sutures [Срок оценки: Evaluation will be conducted at the removal of the sutures (7 days after surgery)]

Вторичные конечные точки (2)

• Clinician evaluation [Срок оценки: Clinical evaluation will be collected at the removal of the sutures (7 days after surgery)]
• Patient reported outcomes [Срок оценки: These parameters will be collected 7 days after surgery (at sutures removal)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Hospital Dental Clinic — Padua

Публикации

• 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. PMID 29717362

Идентификаторы

NCT: NCT07498361 · AOP3206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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