Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Marginal Bone Loss
研究概览
简要总结
This study focuses on the comparison of different implant abutment connections configurations in implant supported screw retained fixed dental prostheses assessing their clinical and radiographic outcomes and to evaluate which implant abutment connection configuration have less biological and technical complications.
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, patients who will receive 2 internal connection dental implants to replace 3 posterior missing teeth in the mandible with a 3 unit screw-retained FDP with sufficient bone volume and controlled oral hygiene. The intervention group will receive a screw-retained FDP with conical engaging and non engaging abutment configuration, while the comparator group will a screw-retained FDP with both conical non engaging abutment configuration. The primary outcome is changes in marginal bone levels, and the secondary outcomes include technical and mechanical complications, biological complications, and patient satisfaction.
Both groups will receive 2 internal connection implants in the posterior mandible in healed sites of at least 3 months (guided implant surgery). The surgical procedure will follow standardized protocols, with no variations between groups other than the types of implant abutment connections used.
Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: definitive loading, after 6 months of loading, after 2 years loading.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking Description
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
- •Adult patients with edentulous span in the posterior mandible of 3 missing teeth.
- •Candidates for an implant supported FDP in the posterior mandible.
- •Teeth in area of interest extracted at least 3 months prior.
- •Bone grafting not needed or only minor GBR needed.
- •Controlled oral hygiene.
- •Sufficient bone volume.
排除标准
- •Patients with edentulous span of less than 3 missing teeth (not eligible to receive a 3 unit 2 implant supported FDP)
- •Patients with healing period of extraction sites less than 3 months.
- •Extensive bone grafting required prior to or during implant placement.
- •Active Bruxism.
- •Heavy smoker (> 10 cigarettes).
- •Systemic diseases that might affect bone healing.
- •Patients who are not willing or unable to give consent.
研究组 & 干预措施
hexed non hexed
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using hexed and non hexed abutments
干预措施: hexed non hexed (Device)
non hexed non hexed
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments
干预措施: non-hexed non-hexed (Device)
结局指标
主要结局
Marginal Bone Loss
时间窗: Baseline (day of definitive loading) and at 1-year follow-up post-loading.
Marginal bone level changes by standardized periapical radiographs.
次要结局
- Technical or mechanical complications(1 year)
- Biological complications(1 year)
- Patient satisfaction(1 year)
研究者
Mohammad AL-Rababáh
Associate Professor
University of Jordan