Influence of Implants and Locators for Improved Retention of Mandibular Full Dentures on Patient's Quality of Life and Oral Function. A Controlled, Randomized and Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Quality of life (OHIP-G-49)
研究概览
简要总结
The aim of this study is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function.
详细描述
For this prospective randomized controlled clinical trial patients with edentulous mandibles and tissue supported (full) dentures were treated with 2 dental implants and locators in order to improve prosthesis stability.
The LOCATOR System is comprised of three parts: The LOCATOR implant attachment (LOCATOR abutment), the LOCATOR Male and the LOCATOR Denture Cap. The abutment is inserted directly into the implant using a torque wrench, while the Denture Cap is placed into the base of the overdenture for polymerization using acrylic resin. Custom retention is achieved via LOCATOR Males - small color-coded (according to retention force) plastic inserts - which can be exchanged as needed.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 45-80 years (male or female)
- •sufficient full dentures in the mandible
- •must be able to clean their teeth on their own
- •edentulous mandible with interforaminal adequate bone for insertion of implants
- •implantation sites free of infections and root fragments
- •no need for treatment of the maxillary teeth
- •Written Informed Consent
排除标准
- •systemic diseases
- •mental disability that may affect the participant's ability to properly follow study instructions
- •oral mucosal diseases
- •long-term medication with steroids, bisphosphonates
- •known allergic reactions to dental materials
- •malignant tumor in the head and neck area
- •requirement of any concurrent radiotherapy or chemotherapy or any radiotherapy or chemotherapy within the last 10 years pregnancy or breastfeeding at study entry
结局指标
主要结局
Quality of life (OHIP-G-49)
时间窗: 3 months after randomization
The oral health-related quality of life is assessed by the German version of the Oral Health Impact Profile questionnaire (OHIP-G-49, Locker et al 1993)
次要结局
- Mucosal recessions(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- width of keratinized gingiva/mucosa(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- Gingival index(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- intraoral photo-documentation(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- masticatory function(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- Plaque index(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- Probing pocket depth(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))
- Gingival recessions(3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3))