Vallecular Bolus Aggregation During Swallowing of Solid Food Boluses for Subject Rehabilitated With Mandibular Implant Retained Overdentures. A Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- swallowing evaluation
研究概览
简要总结
evaluate the effect of implant retained mandibular overdenture on vallecular bolus aggregation during chewing and subsequent swallowing of solid food consistency.
详细描述
Healthy edentulous subjects seeking prosthetic treatment at the prosthodontics department, Faculty of Dentistry, Mansoura University will be eligible for this study. The inclusion criteria will be: age >60 year; Class I maxilla-mandibular relation; available inter-arch space; and adequate bone quality and quality in the mandibular anterior alveolar ridge (inter-foraminal area). Subjects with physical or cognitive limitations, neurodegenerative disorders that could influence their swallowing function, parafunctional habits, smokers, signs or symptoms of temporomandibular disorders, osteoporosis, uncontrolled systemic diseases, previously undergone radiotherapy or laryngeal surgery will be excluded from the study.
Sample size estimation is based on a previous study evaluated the oral and pharyngeal phases of swallowing by videofluroscopy and found significant differences between groups. We determined that 16 participants will be required for the detection of significant differences with effect size of 0.78, 90% power, and 5% error probability. Ethical agreement will be taken from ethical committee of the faculty of dentistry and written consent will be gotten from all the participants after illustrating in detail the whole research protocol.
Prosthetic and surgical procedures:
For each patient, new conventional complete denture will be constructed with optimal denture extension and lingualized balanced occlusal scheme. The new prosthesis will be inserted intraorally and adjusted for occlusal interferences. Subsequently, two dental implants will be placed in the canines region according to guided surgery protocol and two-stage approach. After osseointegration, locator attachments will be screwed to the dental implants to convert the conventional mandibular denture to mandibular implant retained overdenture. The mandibular implant overdentutre will be inserted and occlusal adjustment will be done and follow up visits will be scheduled.
II- Evaluation method:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age >60 year.
- •Class I maxilla-mandibular relation;
- •Available inter-arch space.
- •adequate bone quality and quality in the mandibular anterior alveolar ridge (inter-foraminal area).
排除标准
- •Subjects with physical or cognitive limitations,
- •Neurodegenerative disorders that could influence their swallowing function,
- •Parafunctional habits,
- •Signs or symptoms of temporomandibular disorders,
- •Osteoporosis,
- •Uncontrolled systemic diseases,
- •Previously undergone radiotherapy or laryngeal surgery
结局指标
主要结局
swallowing evaluation
时间窗: after 3 months of denture and overdenture insertion
videofluroscopy evaluation for swallowing function
次要结局
未报告次要终点
