Effects of Early Loading Protocol on the Survival of the Nobel N1 Implant System: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Implant survival
研究概览
简要总结
The purpose of the study is to evaluate whether N1 dental implants are successful when a final crown is placed on them at 6 weeks from implant placement surgery.
详细描述
This study aims to evaluate the survival and stability of the Nobel N1 dental implant and its accompanying crown over a one-year period when the crown is placed either 6 or 12 weeks after implant placement. The Nobel N1 implant is an FDA-approved, newly designed implant featuring an innovative surgical placement protocol intended to minimize bone trauma, promote faster integration, and potentially allow for the placement of final crowns earlier-at 6 weeks instead of the traditional 4 to 5 months. This study will enroll adult participants who are missing a single tooth in the back of the mouth.
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
- Single (Outcomes Assessor)
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
- •Males and females, age 18 or older
- •Can provide an Informed Consent in English.
- •Absence of a single posterior tooth in mandible or maxilla with presence of natural neighboring teeth (except for second molar which only requires presence of first molar)
- •Presence of antagonist teeth
- •Possibility and will for an immediate restoration.
- •Systemic health recorded as an American Society of Anesthesiologists (ASA) I or II
排除标准
- •· Unavailability to attend the follow-up visits.
- •A systemic contraindication for oral surgical procedures; ASA III or IV.
- •Pregnancy or nursing on screening or before the surgical procedure.
- •Diseases that could alter healing or bone metabolism (uncontrolled diabetes, diagnostic osteoporosis, etc.),
- •Taking medications that are altering healing or bone metabolism (bisphosphonates, long-time corticosteroids intake, RANK inhibitors, etc.)
- •Alcohol or drug abuse.
- •Current heavy smoking behavior (≥10 cigarettes/day).
- •Radiation therapy to the head or neck region.
- •Pathology in the implant planned sites that prevent implant placement.
- •Current diagnosis of Diabetes, which is uncontrolled (>7 HbA1C).
- •Need for sinus lift or vertical bone augmentation
- •Previously failed implant site
结局指标
主要结局
Implant survival
时间窗: 6 months, 1 year
Implant survival will be measured if it is not failed and still present at time points
Misch implant success criteria
时间窗: 6 months, 1 year
Implant success will be measured according to Misch et al.
次要结局
- Marginal bone loss(6 months, 1 year)
- Probing depth(6 months, 1 year)
- Presence of sulcular suppuration on gentle probing(6 months, 1 year)
- Presence of sulcular bleeding on gentle probing(6 months, 1 year)
- Peri-implant Mucosal Tissue Index(Prosthetic delivery, 6 months, 1 year)
- Patient satisfaction questionnaire(Prosthetic delivery, 6 months, 1 year)
- Prosthetic complications(6 months, 1 year)