Patient Satisfaction With the Use of Three Different Systems as Retention for Implant Supported Mandibular Overdentures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- OHIP-EDENT linguistic and cultural adaptation in Romanian
研究概览
简要总结
The aim of the study is:
- To validate the Romanian translation of OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form of OHIP (Oral Health Impact Profile) developed by Allen and Locker for edentulous adults. The OHIP questionnaire is an efficient instrument for assessment of OHRQoL - Oral Health-Related Quality of Life.
- To compare satisfaction of 69 fully mandibular edentulous patients rehabilitated with implant-supported overdentures with three different types of retention: Retentive Anchors, Magnets, Locator.
详细描述
Fully edentulism can substantially affect oral and general health as well overall quality of life and inappropriate treatment using classical prosthesis may impaired buccal function, increase alveolar bone loss and also is often unsatisfactory for most patients.
Implant-retained dentures provide successful long-term outcomes, particularly when used to rehabilitate the edentulous mandible (Assad et al. 2004; Chan et al. 1995; Davis et al. 1999). Results achievable with such prostheses are well known: the degree of stability, chewing efficiency, and ultimately patient satisfaction exceeds the benefits obtained with conventional denture treatment.
However few studies have addressed the perception of treatments outcomes by patients and is critically important to determine whether there are meaningful differences based on the type of retention used (Retentive Anchors, Magnets, Locator).
OHIP-EDENT (Oral Health Impact Profile in Edentulous Adults), the short form (19 items) of OHIP (Oral Health Impact Profile) detects the impact of oral health in the quality of life of patients who wear total prosthesis and include questions addressing masticatory capacity, pleasure of eating, level of comfort and relationship problems.
This questionnaire is validated in several languages but still not available in Romanian.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully mandibular edentulous patients
- •Complains about the stability of the existing mandibular denture satisfactory from a technical point of view.
- •Acceptance of a mandibular over-denture retained by two endosseous implants.
- •Patients agree to a 5-year follow-up period.
排除标准
- •Insufficient bone volume (height and with) for inserting at least a 10 mm implant (Ø 4,1).
- •Angle class II relationship.
- •Physical severe consideration that will affect the minimal invasive surgical procedure or constitute a hindrance for a 5-year follow-up.
- •History of radiotherapy in the head and neck region.
- •History of pre-prosthetic surgery (including bone graft procedures) or previous oral implants.
结局指标
主要结局
OHIP-EDENT linguistic and cultural adaptation in Romanian
时间窗: Two-weeks
Steps for validation: * linguistic and cultural adaptation of the original instrument to Romanian; * pilot study to assess face and content validity; * main study to assess the reliability and construct validity. OHIP-EDENT questionnaire includes 19-items addressing masticatory capacity, pleasure of eating, level of comfort, and relationship among others while wearing the prosthesis and detects the impact of oral health in the quality of life of edentulous adults wearing total prosthesis. Response categories:4=very often; 3=fairly often; 2=occasionally; 1=hardly ever; 0=never/don't know.
次要结局
- Evaluation of patient satisfaction with the use of three different systems as retention for implant supported mandibular overdentures.(5 years)
研究者
Corina Marilena Cristache
Dr Corina Marilena Cristache, DMD, PhD, senior lecturer
Concordia Dent Srl