Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Microbiological evaluation of the sutures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non smoker patients
- •clinical indication to third molar surgical removal
- •patients who are able to express informed consent
排除标准
- •pregnant female
- •subjects treated with medications that affect bone metabolism
研究组 & 干预措施
Polysorb group
Standard absorbable sutures will be applied on these patients.
干预措施: Standard absorbable sutures application (Device)
Velosorb group
Fast absorbable sutures will be applied on these patients
干预措施: Fast absorbable sutures application (Device)
结局指标
主要结局
Microbiological evaluation of the sutures
时间窗: 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.
次要结局
- 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))
研究者
Stefano Sivolella
Principal Investigator
University of Padova, School of Dental Medicine