Randomized, Monocentric, Double Blinded, Prospective Study to Evaluate the Early Wound Healing After the Utilization of NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- early wound healing score (EHS)
研究概览
简要总结
The aim of this study is to prove that Novosyn Quick and Monosyn Quick are equivalent in early wound healing in adult patients undergoing resective periodontal surgery.
In order to show equivalence between Novosyn Quick and Monosyn Quick EHS, which is composed of 3 parameters: clinical signs of reepithelization, clinical signs of haemostasis and clinical signs of inflammation, will be calculated for each suture 10 ± 5 days postoperatively and cannot differ more than 2 points.
Furthermore, complications, the handling of the suture material, pain, satisfaction of the patient and bacterial contamination of the thread (optional) will also be assessed as secondary objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and the observers (assessors) will be blinded to the applied suture material.
Patients will not be informed which suture material will be applied. The observers (assessors) who will perform the assessment of the wounds will also be unaware of the applied suture type.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient undergoing resective periodontal surgery abd one of the incisions below has been performed:
- •Crestal incision
- •Vertical incision
- •Intrasulcular incision
- •Submarginal incision
- •Written informed consent regarding the data collection for the RCT
排除标准
- •Emergency surgery.
- •Pregnancy.
- •Breastfeeding
- •Patients taking medication that might affect wound healing.
- •Patients having a condition that might affect wound healing.
- •Patients with hypersensitivity or allergy to the suture material
研究组 & 干预措施
Novosyn®
Novosyn® Quick is available in a range of gauge sizes and lengths, non-needled or attached to stainless steel needles of varying types and sizes: Novosyn® Quick sutures are available undyed in sizes USP 2 (5 metric) through USP 6-0 (0.7 metric).
干预措施: Novosyn® in resective periodontal surgery (Device)
Monosyn®
Monosyn® Quick is a sterile, synthetic, absorbable, monofilament surgical suture material made from a triblock copolymer comprising glycolide (72 %), ε-caprolactone (14 %) and trimethylene carbonate (14 %), which is only available undyed.
干预措施: Monosyn® in resective periodontal surgery (Device)
结局指标
主要结局
early wound healing score (EHS)
时间窗: 10 ± 5 days postoperatively
The primary end point in order to evaluate the primary objective of the study will be the determination of early wound healing score (EHS) in patients undergoing resective periodontal surgery. The EHS will be evaluated in 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH), and clinical signs of inflammation (CSI). Zero, 3 or 6 points have been used to evaluate the CSR, whereas 0, 1, or 2 points have been used for both CSH and CSI (Table 3). The summation of these 3 parameters generated the EHS. The EHS for ideal wound healing was 10 points, while the worst possible score was 0 points. An EHS of 0 points was assigned in the presence of suppuration, independently of the ratings for the 3 single parameters.
次要结局
- Number of patients showing postoperative wound dehiscence(10 ± 5 days postoperatively)
- Number of patients showing postoperative Swelling(10 ± 5 days postoperatively)
- Number of patients with Bacterial contamination of the thread (optional)(10 ± 5 days postoperatively)
- Number of patients showing postoperative Oral candidiasis(10 ± 5 days postoperatively)
- Number of patients showing postoperative Bleeding(10 ± 5 days postoperatively)
- Number of patients showing postoperative Infection(10 ± 5 days postoperatively)
- Satisfaction of the patient(10 ± 5 days postoperatively)
- Number of patients showing postoperative Dentinal hypersensitivity(10 ± 5 days postoperatively)
- Number of patients showing postoperative Angular cheilitis(10 ± 5 days postoperatively)
- Number of Systemic complications(10 ± 5 days postoperatively)
- Pain assessment(10 ± 5 days postoperatively)
- Assessment of the handling of the suture material(intraoperatively)