A Randomized, Multicentre, Double Blind, Parallel Study to Evaluate the Performance and Safety of the Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the "Index Implant" Comparing Coated and Uncoated Implants
研究概览
简要总结
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
详细描述
The study will consist of two parts. Part I, is the main study ending when all subjects have reached visit 5. The study will be evaluated and Clinical Study Report (CSR) will be written for this part.
Part II, of the study is a post-follow up study starting when the first subject has completed visit 5. There will be a separate CSR written for Study Part II.
The study Part I will begin with a baseline visit, visit 1, Informed consent procedure will take place. Provided the subject will give informed consent for both Study Part I and Study Part II the screening procedure starts. Subjects will undergo all screening and baseline assessment procedures including assessments of dental status to determine number of implants needed. Subjects who meet all the inclusion criteria and none of the exclusion criteria will be given a date for implant surgery within three weeks. The required number of implants will be ordered from the Study Distributor.
At the implantation day, visit 2, eligibility will be re-checked before the surgery procedures starts. The subjects who still are eligible will enter the treatment and the implantation surgery is conducted. The first follow-up visit after implantation will take place week 2 post-surgery and the last follow-up visit in Study Part I will be at week 12. Any post-surgical complications and adverse events will be collected and recorded in the eCRF. On demand, depending on the outcome of the surgery, additional visits might occur.
Study Part II, the Post Follow-up Study, consist of two visits, one at month 12 and another visit at month 24 post-surgery. Post-surgical complications and adverse events from Study Part I will be followed-up if not resolved previously. Safety, survival rate and marginal bone loss will be assessed and outcome recorded in the eCRF. Additional visits might occur depending on the status of the subjects.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The devices are delivered single packed and sterile to distributor. The distributor performs blinding, randomization and distribution. The labels are, after blinding of lot number, identical for both the Active and the placebo device.
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
- •Male or female subjects aged >18 years
- •Subjects should be willing to take part, able to understand the information given to them, and give written consent
- •Subject diagnosed with partial edentulism and who needs at least one dental implant in the posterior upper jaw i.e. premolars to first molar. The same subject may also need implants in the posterior mandible (premolars to first molar region)
排除标准
- •Suspected to be immunocompromised or are taking immunosuppressant
- •Current participation in another clinical investigation or participation within the last 6 months
- •Known sensitivity/allergies to any of the test materials or any of their ingredients, such as bisphosphonate, titanium or human fibrinogen
- •Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, or psychiatric disease, hypercalcaemia, previous or ongoing malignancy in the head and neck region or uncontrolled diabetes type I which in the opinion of the Investigator, would compromise the safety of the subject or affect the outcome of the investigation
- •Pregnant and lactating females or those actively seeking to become pregnant in the next 3 months
- •Previous (last 5 years) or on-going Bisphosphonate or Denosumab treatment
- •Significant marginal bone loss prior to implant insertion requiring bone grafting or bone graft substitute
- •Subject with extraction(s) performed in the position of implant placement within the last 2 months
- •Subject with need of >6 implants or a full bridge
- •The final prosthetic construction in need of support from neighbouring teeth
- •Known drug or alcohol abuse
- •Subjects only needed implant(s) in the posterior mandible region
结局指标
主要结局
Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the "Index Implant" Comparing Coated and Uncoated Implants
时间窗: 12 weeks
The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the "index implant" between coated and uncoated implants. An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100 1 No stability 100 stability The aim is to get as close to a 100 as possible
次要结局
- Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants(Week 8 and 12)
- To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12(week 8 and week 12)
- Incidence of Post-surgery Complications and Adverse Events(Day1 to week 12)
- Change in ISQ Highest Value for All Other Implants(week 8 and week 12)
- Survival Rate for All Implants(24 months)
- Change in ISQ (Implant Stability Quotient) Highest Value for the "Index Implant"(Day 1 to week 8)
- Change in Marginal Bone Height for All Implants(Day 1, month 12 and 24)
- Change in Marginal Bone Height for All Other Implants(week 8 and 12)
- Post-surgical Complications and Other Adverse Events (AEs) for All Implants(month 24)
- Occurrence of Signs Associated With Peri-implantitis for All Implants(Month 12 and 24)