Clinical- and Patient-related Outcomes of 4 mm Ultra-short Implants Compared to 8 Mm-long Implants With Bone Augmentation for the Rehabilitation of Posterior Atrophic Maxilla: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Satisfaction of the surgical procedure
研究概览
简要总结
This study aims to compare 2 different groups of patients with both a healed site in the upper posterior sector after extractions, one treated with ultra-short implants, and another with long implants with bone regeneration. The objective is to evaluate if short-implants are superior in terms of better clinical outcomes, survival rates and safety, reduced surgical time, postoperative discomfort, and complication risk compared to conventional implants and bone regeneration.
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
- None
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
- •Inform consent signed.
- •Adult patients (≥18 years old).
- •No pregnant women or without the desire to stay.
- •Periodontal and peri-implant health in a pristine or reduced periodontium.
- •Full mouth plaque score < 20% (O'Leary, 1972)
- •Maxillary multiple posterior maxillary healed sites at least 4 months after extraction (with antagonist teeth with a good prognosis (Lindhe et al. 2008)) presenting ≥ 6.5 mm of bone width and 5-6 mm in height from the bone crest to the floor of the sinus.
- •Need for a multiple splinted implant supported restoration with distal adjacent teeth or distal free-end in the posterior maxilla
排除标准
- •Patients with uncontrolled systemic diseases.
- •Smoker patients (≥10 cig/day).
- •Patients taking medications that affect bone metabolism or immunologic disorders.
- •Patients allergic to penicillin.
- •Patients presenting acute or chronic maxillary sinus lesions.
- •Advanced vertical crestal bone atrophy in the posterior maxilla (Type V and IV, Cawood-Howell Classification)
- •Vertical space of < 6 mm for a screw-retained implant restoration.
- •Patients referring allergy to titanium or to any component of the implant/restoration.
- •No previous attempts of implant installation in the same surgical site.
- •Pregnant or lactating women.
- •Patients willing to start or in course of an orthodontic therapy.
研究组 & 干预措施
ultra-short implants
4mm long implants
干预措施: Ultra short implants (Device)
long implants with bone augmentation
8mm long implants after transcrestal sinus floor elevation with bone augmentation
干预措施: Long implants with bone augmentation (Device)
结局指标
主要结局
Satisfaction of the surgical procedure
时间窗: The day of the intervention after the surgery is finalized
The patient is gonna make a subjective assessment of satisfaction of the surgery once it is finished. For that, we are going to use a 10 centimeter visual analog scale. The extremes of the scale are the extreme expressions of satisfaction, where the extreme left represents a 0 (not satisfied) and 10 (very satisfied). The patient won't have numbers between 0-10 so he will not be influenced by them. Wherever he marks, we will measure it and it will represent in centimeters how was his satisfaction
次要结局
- Post-surgical complications(7 days after the surgery)
- Surgical time(at the day of the intervention, since the administration of the anesthesia until the placement of the last suture knot)
- Pain Intensity(Since the day of the intervention once the surgery is finalized , until the 7th day after the surgery, each day of the following 7 days)
- Rescue medication(After the surgery during the next 7 days)
- Intra-surgical complications(The day of the surgery)
- Implant survival(From 10 weeks after surgery to 36 months, after restoration delivery)
- Marginal bone level changes(The day of the surgery, 12 months after and 36 months after)
- Probing pocket depth(12 months after surgery and 36 months after surgery)
- Bleeding on probing(12 months and 36 months after surgery)
- Suppuration on probing(12 months and 36 months after surgery)
- Keratinized mucosa width(12 months and 36 months after surgery)
- Soft tissue dehiscence(12 months and 36 months after surgery)
- Prosthetic complications(12 months and 36 months after surgery)