Influence of the Implant Loading Protocol on Implant Survival in Early Placed Single-tooth Implants in Mandibular First Molar Sites Using Computer-assisted Implant Surgery: A Randomized Clinical Trial (RCT).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Implant Survival
研究概览
简要总结
In this study, participants with one lower first molar that require removal and replacement using dental implants will be enrolled. The implant will be inserted 12-16 weeks after tooth extraction and restored either immediately with an artificial tooth (fixed implant crown) in 50% of the cases or 4 weeks later in the remainder 50%. Immediate and early loading will be compared and the investigators expect no difference in terms of implant success and health of the tissue around the implant.
详细描述
Background
Dental implants placed between 12 and 16 weeks after tooth loss are a well-documented treatment option. Placing the artificial tooth (implant crown) on the implant the same day (immediate loading) or approximately 4 weeks after implant placement (early loading) are also treatment options with good scientific documentation. Computer-assisted implant surgery (sCAIS) and modern implant materials/surfaces increase treatment predictability and success in this context.
Clinical relevance
The timing of implant placement post-extraction and subsequent implant loading cannot be separated in modern implant therapy any longer. At the "Sixth ITI Consensus Conference" in Amsterdam, it was concluded that the clinical evidence and documentation of early implant placement combined with immediate or early implant loading in partially edentulous patients is currently insufficiently documented. However, this treatment protocol seems to be widely applied in daily practice. The planned study is designed to provide evidence for the application of early implant placement with partial bone-healing and either an immediate or an early loading protocol.
Hypothesis/Specific aims
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years
- •Willingness to sign informed consent and to participate in the study
- •Plaque index according to Silness and Loe of < 35% [26]
- •Presence of a mandibular first molar that has to be extracted
- •Sufficient vertical interocclusal space for the placement of an implant crown (7 mm)
- •Presence of an opposing natural or artificial tooth
- •Ridge height sufficient for the placement of a ≥ 10 mm-long implant
- •Sufficient ridge width for the placement of a 4.1mm diameter implant
排除标准
- •Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol
- •Any disorder that would interfere with wound healing or represent a contraindication for implant surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
- •Pregnancy or lactation
- •Intention to become pregnant between inclusion and implant loading
- •Heavy smoking habit with ≥ 10 cig/d
- •Severe bruxism or clenching habits, present oro-facial pain
- •Insufficient ridge width/height for the study implant
- •Defect of any alveolar wall (secondary exclusion criterion at tooth extraction)
- •ISQ < 70 (secondary exclusion criterion for Group A at implant placement, for Group B at loading visit)
研究组 & 干预措施
Immediate Loading
Group A. The implant receives an artificial tooth the same day as it is placed.
干预措施: Immediate Loading (Procedure)
Early Loading
Group B. The implant receives an artificial tooth 4 weeks after placement.
干预措施: Early Loading (Procedure)
结局指标
主要结局
Implant Survival
时间窗: 12 months
Number of implants from both groups (i.e. immediate loading vs. early loading) fulfilling the criteria of survival and success after 12 months. The criteria are: * Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (e. g. painful sensation) * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if observed at two or more follow-up visits after the treatment with systemic antibiotics) * Absence of implant mobility on manual palpation * Absence of any continuous peri-implant radiolucency
次要结局
- Patient's satisfaction(10 years)
- Clinical peri-implant soft tissue dimensions(10 years)
- Accuracy of digital implant planning(12 months)
- Prosthetic Success(10 years)
- Crestal bone level(10 years)