Primary Stability and PES/WES Evaluation for Immediate Implants in the Aesthetic Zone: a Clinical Double-blind Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Bone level
研究概览
简要总结
The use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. The aim was to assess whether the implant design affects primary (PS) and secondary stability (SS), bone level (BL), and PES/WES evaluation.
详细描述
20 implants with two different designs (n=10) were immediately placed in the upper anterior maxilla with no grafting material. ISQ, BL, and PES/WES were evaluated. Results will analyze with the Wilcoxon-Mann-Whitney test (p<0.05).
The random distribution is made prior to assignment following the internet prgram https://www.random.org
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
- Double (Participant, Investigator)
盲法说明
Double (participant, investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who presented aa vertical fracture in an upper incisor that can not be treated conservatively and ended in the extraction, and the treatment needed is a unitary implant.
- •Good systemic health status (ASA I or II).
- •Oral hygiene index of < 2 (Löe and Silness).
- •A minimum of 2 mm of attached mucosa.
- •A minimum of 8 mm of vertical bone.
- •A minimum of 7 mm of bucco-lingual bone.
排除标准
- •Traumatic or complicated incisor extraction.
- •Pregnant or women in the lactation period.
- •Use of any medication that contraindicates implant treatment.
- •A history of alcohol or drug abuse.
- •A requirement for guided bone regeneration.
- •A requirement for tissue graft augmentation.
- •Failure to comply with the study protocol.
结局指标
主要结局
Bone level
时间窗: After 12 months of definitive implant load
The bone level (BL) was determined by an intraoral digital radiograph taken parallel to the long axis of the implant. The distance from the implant neck to the first contact between the bone and the implant was determined. It was measured in both sides, mesial and distal, and the mean between both values was established as the BL value.
PES/WES
时间窗: After 12 months of definitive implant load
Pink Esthetic Score/White Esthetic Score \[PES/WES\] The parameters evaluated by this index are (1) mesial papilla, (2) distal papilla, (3) curvature of facial mucosa, (4) level of facial mucosa, and (5) root convexity/soft tissue color and texture. Each parameter range between 0 and 2. A maximum score of 10 can be obtained, considering acceptable from 6 The WES focuses specifically on the visible part of the restoration and in base on the following five parameters: (1) tooth form, (2) tooth volume/outline, (3) color (hue and value), (4) Surface texture, and (5) translucency. Each parameter is evaluated by comparison with the adjacent teeth, giving a value ranged from 0 to 2. A total score of 10 can be obtained, considering acceptable from 6
次要结局
未报告次要终点
研究者
Arturo Sánchez-Pérez
Associate professor
Universidad de Murcia