Immediate Loading Of Dental Implants In Mandible Full-Arch: A Pilot Clinical Study On Patients Satisfaction, Quality Of Life And Implant Success
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Patient Satisfaction With the Immediate Loading Protocol
研究概览
简要总结
Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.
详细描述
In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Investigators were not involved in data analysis
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimal age of 18 years
- •Complete edentulism for more than 1 year
- •Wear of total conventional prosthesis for more than 1 year
- •Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).
排除标准
- •Any absolute or relative contra-indication to implant therapy
- •Physical incapacity to render oral or prosthetic hygiene
- •Incapacity to obtain a free and informed consent
- •Incapacity to assist to planned follow up appointments
- •Incapacity to understand and complete questionnaires
- •Exclusion Criteria to Immediate Loading Protocol Found on One or Both of Un-splinted Implants During Surgery:
- •Inadequate bone quality: IT<35 Ncm
- •Inadequate primary stability: ISQ<60
结局指标
主要结局
Patient Satisfaction With the Immediate Loading Protocol
时间窗: 4 months
Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).
Oral-health-related Quality of Life With the Immediate Loading Protocol
时间窗: 4 months
Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.
次要结局
未报告次要终点
研究者
Elham Emami
D.D.S., M. Sc., Ph. D, Professor
Université de Montréal