Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Extraction success
研究概览
简要总结
The aim of the study is to compare the effectiveness of the vertical extraction system Benex and Physics forceps with the conventional extraction tools (extraction forceps and elevators) in the early wound healing period after tooth extraction, as means for minimally invasive tooth extraction.
All patients aged 18 years and over who require closed tooth extraction with good oral hygiene were eligible for participation.
Participants were randomly allocated to tooth extraction with either Benex, Physics forceps or conventional extraction tools using box randomization. Patients are followed up during the recovery period to assess pain and early wound healing, while at the time of extraction, success and buccal cortical plate fracture were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients with teeth indicated for closed extraction
- •Teeth with at least 1mm of tissue above the bone level
- •Patients without contraindications for surgical intervention (ASA 1 or 2)
- •Patients with good oral hygiene
排除标准
- •Patients with severe systemic conditions or immunosuppression
- •Teeth with mobility greater than Grade 1
- •Teeth indicated for open surgical extraction
- •Patients with acute odontogenic infections
- •Drug or alcohol abuse
- •Patients with psychiatric conditions
- •Patients on anticoagulant or antiaggregant drugs refusing to undergo prior tests and preparation for tooth extraction
- •Patients on chemotherapy, radiotherapy, or oral bisphosphonate intake
研究组 & 干预措施
Benex tooth extraction
This is the first study group where patients undergo extractions with presumably the vertical tooth extraction system Benex.
干预措施: Tooth extraction (Procedure)
Benex tooth extraction
This is the first study group where patients undergo extractions with presumably the vertical tooth extraction system Benex.
干预措施: Benex (Device)
Physics forceps extraction
This is the second study group where patients undergo extractions with the presumably minimally invasive Physics forceps.
干预措施: Tooth extraction (Procedure)
Physics forceps extraction
This is the second study group where patients undergo extractions with the presumably minimally invasive Physics forceps.
干预措施: Physics Forceps (Device)
Convetional extraction
This is the control group where patients undergo tooth extractions with conventional extraction forceps and elevators.
干预措施: Tooth extraction (Procedure)
Convetional extraction
This is the control group where patients undergo tooth extractions with conventional extraction forceps and elevators.
干预措施: Conventional Extraction Forceps (Device)
结局指标
主要结局
Extraction success
时间窗: From the beginning of the extraction to the completion of the procedure
The scale suggested by Choi was used to assess each of the extraction systems. Scored from 1 to 5. Higher is better.
VAS pain score
时间窗: 0, 1, 3, 7 day
Patients were asked to rate their pain experience on a visual analog scale (VAS). Measured in centimeters on 10cm line. Lower is better.
Alveolar bone buccal cortical plate preservation
时间窗: From the beginning of the extraction to the completion of the procedure
The difference between the height of the alveolar bone buccal cortical plate is measured before and after the tooth extraction. Scored in milimeters missing. Lower is better.
Early wound healing
时间窗: 3, 7, 10 day
Landry's early wound healing index was used to evaluated the extraction healing process. Scores from 1 to 5. Higher is better.
次要结局
未报告次要终点