The Effect of Microsurgical Approach to Periodontal Flap Healing: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Early wound healing index
研究概览
简要总结
Scientists do research to answer important questions which might help change or improve the way we do things in the future.
The investigators know that using glasses with special attachments that provide magnification (dental loupes) for dental procedures results in better healing than not using magnification. This study will test if using a microscope, that gives much higher magnification, can result in even better healing than using dental loupes.
详细描述
A two-arm split mouth randomized controlled trial investigating the effect of using an experimental microsurgical approach with a digital microscope (Group 1) or standard of care surgical approach with dental loupes (Group 2) on post-operative wound healing of two standardized vertical releasing incisions. The split mouth design will ensure that each patient serves as their own control.
The hypothesis is that the wound closure technique in Group 1: Microsurgical approach with digital microscope will have improved periodontal flap vertical releasing incision wound healing as compared to the Group 2: Standard of Care surgical approach with dental loupes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability of subject to understand and the willingness to sign a written informed consent document.
- •Males and females; Age 18 -89 years old
- •Require surgical flap treatment of periodontal disease
- •Either maxillary or mandibular arch
- •ASA I or II
- •Has consistent transportation for all clinical and study visits
排除标准
- •Pregnancy, or those planning to become pregnant
- •Diabetics with an HbA1c >7.1
- •Not eligible for surgical periodontal therapy
- •Require vertical or horizontal hard tissue augmentation
- •Non-English speaking
研究组 & 干预措施
Group 1: Microsurgical incision closure
Microsurgical approach to wound closure using a digital microscope to enhance view
干预措施: Microsurgical approach with Digital Microscope (Procedure)
Group 2: Dental loupes incision closure
Standard of care surgical approach to wound closure using Dental Loupes.
结局指标
主要结局
Early wound healing index
时间窗: One, two and three weeks
Assessment of early soft tissue wound healing
次要结局
- Difference in time between procedures(End of surgical procedure at last suture placement)
研究者
Angela Palaiologou-Gallis, DDS, MS
Professor
The University of Texas Health Science Center at San Antonio