Clinical Outcomes of a Cost-effective Implant Treatment in the Edentulous Upper Maxilla: Effectiveness of Removable Prosthesis Retained by 4 Implant-supported Locator-Attachments.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Implant outcomes
研究概览
简要总结
- Hypothesis/Specific aims
The aim of the present study proposal is to validate an implant treatment concept in the edentulous upper maxilla using four implants-supported locators abutments to retain removable prosthesis.
Specific aims:
- The primary objective of the study is to evaluate the implant and prosthodontics success rates of the proposed implant treatment approach after a follow-up period of 1, 3 and 5 years as well as the biological and prosthodontics complications.
- The secondary objective is to assess the evolution of patient centered outcomes with the suggested treatment in the maxilla. Oral health-related quality of life (OHRQoL) and patients' satisfaction relating to their prostheses will be considered.
- The third objective will be to compare the implant, prosthodontics and patient-centered outcomes according to the implant distribution; 4 anterior to maxillary sinus (ANT) versus 2 anterior implants and 2 implants in the maxillary tuberosity (POST).
Hypothesis:
- Implant survival rate using this treatment concept is similar to restoration with implant-supported fixed prosthesis, based on published data. No difference of implant survival rates is found between ANT and POST implant distribution.
- Prosthodontics survival rate using the following treatment concept is similar to the ones found with a bar, based on published data. The ANT implant distribution causes fewer prosthodontics complications compared to the POST implant distribution.
- There is a significant improvement in OHRQoL and patient satisfaction compared to the baseline OHRQoL observed with a conventional removable denture. The levels of improvement OHRQoL and patient satisfaction are similar for ANT and POST implant distributions.
详细描述
1.1 Background and significance
The effectiveness of mandibular overdentures retained by 2 dental implants and its impact on Oral Health-Related Quality of Life (OHRQoL) and patient satisfaction has been extensively documented over the last decades(1-6). According to recent systematic reviews, the implant survival rate of this oral rehabilitation concept reaches more than 95% (7-10). The scientific validation of the efficacy of such a rehabilitation concept has influenced the social security system of several countries like Belgium. Therefore, this treatment approach is nowadays considered as an evidence-based and cost-effective treatment option improving the function and quality of life of mandibular edentulous patients. Unfortunately, cost-effective treatment concept to restore the edentulous maxilla not has been widely documented (11). Many studies display high success rates of fixed implant-supported rehabilitations of the edentulous maxilla (12) but these treatment options remain costly and are therefore reserved to a limited social category of patients.
This work is important because there is a need to provide affordable and efficient implant treatment approaches to restore function and improve satisfaction and OHRQoL of patients with edentulous maxillae.
1.2 Preliminary studies in connection with new projects/continuing projects
Even though some authors have described implant survival rates of implant-retained overdentures in the upper maxilla (8, 13-16), most of the treatment approaches involves bars. The placement of 4 implants and individual attachments is a more cost-effective treatment modality that is poorly documented in the literature in terms of implants and prosthodontics outcomes but also on aspects assessing implant distribution, attachment types and improvement of patient centered outcomes. Therefore, further studies are needed to validate the placement of 4 implants and individual attachment as a reliable treatment modality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physical status according to ASA = 1, 2
- •Wearing a complete upper denture that is adequate and in good conditions
- •Signed informed consent form describing the purpose and process of the study
排除标准
- •Uncontrolled periodontitis/peri-implantitis (lower jaw)
- •Lack of bone for the placement of 4 implants of 3.3 diameter and 8 mm with bone regeneration.
- •Tobacco use > 10cigarettes/day
结局指标
主要结局
Implant outcomes
时间窗: 5 years
At each follow-up visit (3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years), a clinical exam including plaque assessment, bleeding on probing and mucosal palpation will be done. A CBCT scan will be done directly after surgery and at one year post-surgery. Specifically, the integration will be considered successful if the following parameters are met: (1) absence of recurring peri-implant infection with suppuration; (2) absence of persistent subjective complaints such as pain, foreign body sensation, and/or dysesthesia; (3) absence of a continuous radiolucency around the implant; and (4) absence of any detectable implant mobility. Marginal bone levels will be measured using CBCT radiograph at baseline and 1, 3 and 5 years follow-up, using the implant neck as reference point and calibrating them using Image J64. Marginal bone remodeling will be calculated accordingly. CBCT radiographs will be taken using the bisector technique.
次要结局
- Prosthodontics success rates(5 years)
研究者
Dr. France LAMBERT
Head of Clinic
University of Liege