Immediate Vs. Early Loading of Immediately Placed Bone Level Tapered Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Implant stability
研究概览
简要总结
The study aims to compare implant stabilities between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in the partial and total edentulous patients assessing marginal bone loss, oral health-related quality of life, and patient satisfaction within one, two and five years of follow-ups.
详细描述
The objectives of the study
The primary objective of this study will be to compare primary and secondary stability between immediate and early loaded, immediately placed bone-level tapered dental implants in the upper jaw in partial and total edentulous patients. The second objective will be marginal bone level changes and soft tissue changes such as keratinised tissue width and gingival thickness which will be assessed at one, two and five years postoperatively. The gained results will assess and compared within partial and total edentulous patients.
Additionally, the study also will be analyse functional and aesthetic outcomes as well as the possibility of the complication and its prevalences including (biological, mechanical, and procedure-related complications) comparing the their incidence between partial and total edentulous patients.
Materials and methods
The study is design as a prospective, randomised, controlled clinical trial which will be conducted at School of Dental Medicine in accordance with the Declaration of Helsinki (World Medical Association, 2013) and the CONSORT Statement.
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)
盲法说明
Only investigators who will assess outcome including radiographic assessment, clinical outcomes and patients clinicians' satisfaction will be blinded all time. These investigators would not be familiar with group allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 18 years of age;
- •systemically healthy;
- •periodontally healthy or with stable treated periodontitis and good oral hygiene (FMPS and FMBS ≤ 15%, measured at six sites per tooth)
- •Have maxillary dentition with one or multiple failing teeth
- •Have sufficient bone volume to immediately place implants
- •Non-smoker or light smoker
排除标准
- •An active or chronic disease that affects bone metabolism or wound healing (ASA III type);
- •Diminished mental capacities that could mitigate the ability to comply with the protocol;
- •History of maxillary augmentation; oral carcinoma or inflammatory changes;
- •History of head and neck radiotherapy.
研究组 & 干预措施
Test: Immediate implant loading
Implants will be immediately following surgical procedure loaded with temporary restorations.
干预措施: Immediate implant loading (Device)
Control: Early implant loading
Implants will not be received prosthetic restoration, and will left with healing abutments (HA) for 6 weeks.
干预措施: Early implant loading (Device)
结局指标
主要结局
Implant stability
时间窗: Change implant stability at 5 years
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
Implant stability
时间窗: Change implant stability at 12 months
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
Implant stability
时间窗: Change implant stability at 2 years
Implant stability is measured using the Resonance Frequency Analysis (RFA) method with Osstell Mentor® (Osstell, Gothenburg, Sweden) and Penguin® (PenguinRFA, Gothenburg, Sweden). The result is expressed as ISQ values.
次要结局
- Change of keratinised tissue width (KTW)(Change baseline marginal bone at 5 years)
- Change of Marginal bone loss (MBL)(Change baseline marginal bone at 5 years)
- Change of Marginal bone loss (MBL)(Change baseline marginal bone at 12 months)
- Change of Marginal bone loss (MBL)(Change baseline marginal bone at 2 years)
- Change of keratinised tissue width (KTW)(Change baseline marginal bone at 12 months)
- Change of keratinised tissue width (KTW)(Change baseline marginal bone at 2 years)
研究者
Aleksa Markovic
Professor
University of Belgrade