A New Syndesmotomy Technique for Tooth Extractions: Preserving the Integrity of the Alveolar Bone
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mean difference of bone sounding (mm) before and after tooth extraction
研究概览
简要总结
In both surgical and nor surgical tooth extractions, the first phase is done by syndesmotomy. This procedure allows to interrupt the fibers of the periodontal ligament. Traditionally, syndesmotomy is done by manual instruments. Usually, the manual approach leads to the loss of the vestibular cortical plate due to the size of those instruments.
The piezoelectric surgery device provides an alternative to manual instruments. Its advantages are: selectivity for hard tissues; better cut control; protection of soft tissue, vessels and nerves; post-op pain and discomfort reduction.
The aim of this study is to evaluate a piezosurgery driven syndesmotomy technique during tooth extraction.
详细描述
Piezoelectric bone surgery is a recent and innovative technology, permitting a selective cut of mineralized tissue while sparing soft tissue. Similar to a dental scaler, a high frequency vibration, in the range of 25-35 kHz, is transmitted to a metallic tip. The handpiece of the instrument is equipped with a sterile irrigation system and light-emitting diode (LED) light, which improves visibility and overall safety. Piezoelectric surgery is particularly useful when performing delicate bone procedures such as periodontal or endodontic surgery. It is also indicated when performing more invasive bone surgery such as maxillectomy, mandibulectomy, and condylectomy, where preservation of neurovascular structures is important. Piezoelectric surgery is still employed in tooth extraction of third lower molars. In literature, there are low evidence of the use of piezoelectric surgery for single-rooted tooth extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years old
- •Single-rooted tooth to extract that:
- •has mobility grade 0 or 1
- •is considered hopeless or needs to be extracted due to orthodontic indication
- •Sign of informed consent
排除标准
- •Age lower than 18 years old
- •Pregnancy
- •Heavy smokers (more than 10 cigarettes a day)
- •Uncompensated systemic diseases
- •Drugs that influence wound healing (radiotherapy in the last year, bisphosphonates)
- •Low compliance due to psychiatric diseases
- •Mobility grade 2 or 3
- •Refusal of informed consent
结局指标
主要结局
Mean difference of bone sounding (mm) before and after tooth extraction
时间窗: Day0, before and after the surgical extraction
Bone sounding is a measurement in millimeters that represents the distance between alveolar crest and free gingival margin. This measurement is taken under local anesthesia before and after the tooth extraction. This outcome provides informations about the integrity of the alveolar bone before and after the surgical procedure. Six sites for tooth are considered. The mean difference expressed in millimeters is considered for each site.
次要结局
- Post-operative pain evaluation: VAS scale value (0-10) at D1, D3, D7 and D21(Day 1, 3, 7, 21 after tooth extraction)
- Post-operative pain trend evaluation: VAS scale values difference (0-10) at D1, D3, D7 and D21(Day 1, 3, 7, 21 after tooth extraction)
- Post-operative quality of life evaluation: QoL score (0-100) at D1, D3, D7 and D21(Day 1, 3, 7, 21 after tooth extraction)
- Post-operative quality of life trend evaluation: QoL score differences (0-100) at D1, D3, D7 and D21(Day 1, 3, 7, 21 after tooth extraction)
- Number of analgesics taken a week after the surgical procedure(From surgical procedure to day 7)
研究者
Manicone Paolo Francesco
Associate professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS