Effect of Different Suture Techniques on Early Healing of Peri-implant Soft Tissue Following Open-flap Implant Surgery in Esthetic Area: a Randomized Clinical Trial Comparing Horizontal and Vertical Mattress Sutures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Blood perfusion volume (PU) change during the observation period
研究概览
简要总结
The purposes of this study are to compare the blood perfusion and early healing of horizontal mattress suture with vertical mattress sutures following open-flap implant surgery. Patients wanting single implant replacement in esthetic area will be recruited. This is a randomized, open-label, controlled clinical trial. Noninvasive procedures will be used to assess the primary and secondary outcomes.
Inclusion Criteria: With sufficient bone width (≥6mm), With mesial-distal distance over 8mm, age over 18, Willing to participate Exclusion Criteria: Patients want multiple adjacent implant replacements in esthetic area, Untreated periodontitis, Smokers, Diabetes mellitus
详细描述
The overall aim of this study is to compare the microcirculation changes of peri-implant soft tissues following open-flap implant surgery using different suture techniques. Subjects fulfilling the inclusion and exclusion criteria will be invited to participate in the study and randomized to one of the two groups: vertical mattress suture (test group) and horizontal mattress suture (control group) on a 1:1 ratio. A laser Doppler flowmetry machine (LDF) (LW1111, LEA) will be used to measure the tissue perfusion. Assessment will be performed at different time, including: Baseline Assessments (presurgical measurements) - T0; Immediate after anesthesia - T1; Immediate after suture - T2; 1 hour after surgery - T3; 2 hours after surgery - T4; 6 hours after surgery - T5; 24 hours after surgery - T6; 72 hours after surgery - T7; 7 days after surgery - T8; 14 days after surgery - T9; 30 days after surgery - T10. The primary outcome is blood perfusion volume (PU) change during the observation period. And secondary outcomes include blood flow velocity change during the observation period, hemoglobin count change during the observation period, blood oxygen saturation change during the observation period; three-dimensional soft-tissue volumetric changes during the observation period, changes in clinical wound healing score during the observation period, PROMs (VAS).
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
- None
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
- •Aged 18 and above
- •Subjects want single implant treatment in esthetic area (premolar to premolar) in maxilla
- •With sufficient bone width (≥6mm)
- •With mesial-distal distance over 8mm
- •Evidence of subject ability to achieve good oral hygiene and control periodontitis in the whole of the dentition (FMPS<20% and FMBS<20%)
- •Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give written informed consent.
排除标准
- •Subjects want multiple adjacent implant treatment
- •Patients with inadequate bone volume where major bone augmentation would be required at implant location.
- •Subjects with untreated periodontitis
- •Current smokers
- •Subjects with diabetes mellitus.
- •Pregnant females
- •Participation in another intervention trial
- •Inability or unwillingness of individual to give written informed consent.
研究组 & 干预措施
test group
vertical mattress suture
干预措施: different suture types (Procedure)
control group
horizontal mattress suture
干预措施: different suture types (Procedure)
结局指标
主要结局
Blood perfusion volume (PU) change during the observation period
时间窗: Immediate after anesthesia;Immediate after suture;1hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7days after surgery;14ddays after surgery;30days after surgery
LEA measurement
次要结局
- Changes in clinical wound healing score during the observation period(24h after surgery;72h after surgery;7 days after surgery;14days after surgery;30 days after surgery)
- Blood flow velocity change during the observation period(Immediate after anesthesia;Immediate after suture;1 hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;14days after surgery;30days after surgery)
- Blood oxygen saturation change during the observation period(Immediate after anesthesia;Immediate after suture;1 hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;14days after surgery;30days after surgery)
- Three-dimensional soft-tissue volumetric changes during the observation period(1. Intra-oral scanning: before surgery;Immediate after suture;1 hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;14days after surgery;30 day after surgery)
- Hemoglobin count change during the observation period(Immediate after anesthesia;Immediate after suture;1 hour after surgery;2hour after surgery;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;14days after surgery;30days after surgery)
- patient reported outcome measures (PROMs, VAS)(Immediate after suture;6hour after surgery;24hour after surgery;72hour after surgery;7 days after surgery;)
研究者
Junyu Shi
Dr.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University