Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Accumulation of soft deposits
研究概览
简要总结
Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Therefore, oral surgery has specific demands for suture materials.
Aim: The primary objective of this study was to compare the bacterial load on different suture materials. The secondary objective was to determine the impact of suture material on decubitus.
Material & methods: This prospective experimental study with a 'split-mouth' design enrolled 36 patients requiring oral surgery. Five different suture materials were compared regarding their microbiological load and decubitus at the suture removal. Bacterial accumulation on the same 5 suture materials was also tested in an in vitro biofilm model.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •36 patients
- •in need for periodontal surgery
- •patients in good general health
- •able to sign IC form
排除标准
- •patients that were deemed unlikely to comply with the study protocol, as judged by the examiner
- •patients who had a present alcohol and/or drug abuse
研究组 & 干预措施
Silk 4.0
Silk suture
干预措施: Silk 4.0 (Device)
PG910 4.0
Vicryl Rapid suture
干预措施: PG 910 4.0 (Device)
PP 4.0
Non-absorbable polypropylene monofilament
干预措施: PP 4.0 (Device)
Silk 5.0
Silk suture
干预措施: Silk 5.0 (Device)
PG910 5.0
Vicryl suture
干预措施: PG910 5.0 (Device)
PP 5.0
Non-absorbable polypropylene monofilament
干预措施: PP 5.0 (Device)
APG 5.0
Antibacterial Vicryl suture
干预措施: APG 5.0 (Device)
ePTFE 5.0
expanded polytetrafluoroethylene
干预措施: ePTFE 5.0 (Device)
结局指标
主要结局
Accumulation of soft deposits
时间窗: 7 to 14 days
Accumulation of soft deposits on each suture material was assessed visually as being present or absent before removing the knots.
次要结局
- Area of inflammation(7 to 14 days)
- Microbial deposits on the sutures(7 to 14 days)