Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Marginal bone level changes
研究概览
简要总结
This study focuses on examining the efficacy and clinical performance of immediate loading of early placed single implants.
The aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and patient-reported outcomes.
Null hypothesis: There will be no significant differences in implant survival/success, stability, radiographic marginal bone level, and patient reported outcomes between immediately or conventionally loaded and early placed implants.
详细描述
Study design:
This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.
The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications.
Both groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time.
Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18 years or older
- •requiring single tooth replacement with dental implants in presence of four bone walls (mandible or maxilla)
- •having adequate bone volume
- •controlled oral hygiene
- •having agreed to take part in the study and willing to comply with the study protocol and follow-up visits
排除标准
- •Any systemic condition that might jeopardize implant surgery
- •history of radiation therapy to the head and neck region
- •history of bisphosphonate therapy or other medications that may affect bone metabolism
- •smoking more than 10 cigarettes/day
- •history of bruxism or parafunctional habits
- •localized/generalized periodontitis
- •patients in need of bone grafting
- •any known allergy or hypersensitivity to implant materials
研究组 & 干预措施
Conventional loading of early placed implants
Early placed implants ( within 16 weeks of healing after Extraction of a tooth) will be conventionally loaded ( at least 8 weeks after implant placement )
干预措施: Immediate loading of early placed implants (Device)
Conventional loading of early placed implants
Early placed implants ( within 16 weeks of healing after Extraction of a tooth) will be conventionally loaded ( at least 8 weeks after implant placement )
干预措施: Conventional loading of early placed implants (Device)
Immediate loading of early placed implants
Early placed implants (within 16 weeks of tooth extraction) will be loaded immediately with provisional screw retained crown
干预措施: Immediate loading of early placed implants (Device)
Immediate loading of early placed implants
Early placed implants (within 16 weeks of tooth extraction) will be loaded immediately with provisional screw retained crown
干预措施: Conventional loading of early placed implants (Device)
结局指标
主要结局
Marginal bone level changes
时间窗: Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group), and at 1-year follow-up post-loading.
Marginal bone level changes by standardized periapical radiographs.
次要结局
- Implant failure rate(1 year)
- Implant stability(Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group))
- Midfacial mucosal level(at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up)
- Pink and white esthetic scores(at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up)
- Patient Satisfaction(after 6 months and 1 year of placements)
- Biological, estehtic and technical complications(1 year)
研究者
Mohammad AL-Rababáh
Associate Professor
University of Jordan