Clinical, Radiographic, and Histomorphometric Analysis of AstraTech Implant EV Placed and Immediately Provisionalized Into Preserved Alveolar Ridges: A Prospective 3-Year Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement.
研究概览
简要总结
The revised purpose of this study is to compare and evaluate the stability of the implant body, survival rate, bone-level changes, and the implant's soft-tissue outcomes over a period of 1 year. Only 1 tooth is studied per participant.
In July of 2024, the revised protocol and revised Statistical Analysis plan were amended post-hoc, and the revised protocol and statistical analysis plan were approved by the IRB review committee in July of 2024.
As a result, the study has been terminated due to a change in the study's data analysis, and so the study will only analyze data up to and including the 1-year point.
详细描述
Group 1: 3 months after ARP-SG, a dental implant will be placed using Azento® with an AstraTech Implant System EV and an immediate implant temporary crown using Azento®. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.
Group 2: 6 months after ARP-SG, a dental implant will be placed using Azento® with an AstraTech Implant System EV and an immediate temporary crown using Azento®. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.
Group 3: 9 months after ARP-SG, a dental implant will be placed using Azento® with an AstraTech Implant System EV and an immediate temporary crown using Azento®. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.
SCREENING - Visit 1 After reading and signing the informed consent form, participants will complete a detailed medical and dental history form. The investigators will review the form with the participant to ensure they can safely participate in the study. Participants will also have an oral exam to determine if the participant qualifies for the study
VISIT 2: Abutment & Crown Placement Group 1 (TE + 14 weeks) Group 2 (TE + 26 weeks) Group 3 (TE + 38 weeks)
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects may identify as either male, female, or intersex
- •Age: 18 years or older
- •Subjects with a healed, single-rooted tooth (except mandibular incisors) that has previously undergone ARP-SG with particulate allograft material within the past 2 months.
- •Subjects must have stable occlusion, with absence of caries or other known acute pathology (i.e., untreated endodontic lesion, periodontal abscess, external/internal resorption, etc.) on teeth proximal to the implant site that would negatively influence implant outcomes
- •Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
- •Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
- •Subjects must have read, understood and signed an informed consent form
- •Subjects must be willing to return for the required number of visits
- •Subjects' tooth must be a permanent tooth, not a primary tooth (also known as baby tooth).
排除标准
- •Mandibular incisors
- •Acute infection associated with the tooth to be extracted or with adjacent teeth
- •Unstable occlusion, presence of caries or other acute pathology on teeth adjacent to the implant site
- •History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use [>10 cigs/day]), history of head/neck radiation, history of chemotherapy within the last 5 years
- •Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
- •Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
- •Pregnant women or nursing mothers
- •Subjects that are unwilling or unable to sign the informed consent
- •History of lack of compliance with dental visits
- •Subjects unwilling to return for the required number of visits
- •Subject currently undergoing orthodontic treatment
结局指标
主要结局
Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement.
时间窗: 1 year after permanent final crown placement
For participants that had permanent restoration of the final crown performed, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 1 year of having the permanent final crown placement. Note: Only 1 implant was placed per participant.
次要结局
未报告次要终点
研究者
Christopher Barwacz
Principal Investigator
University of Iowa