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临床试验/NCT06958055
NCT06958055已完成不适用

Vallecular Bolus Aggregation During Swallowing of Solid Food Boluses for Subject Rehabilitated With Mandibular Implant Retained Overdentures. A Crossover Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年1月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
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

研究组 & 干预措施

group I : complete edentulous patients

Placebo Comparator

videofluroscopy for completely edentulous patients

干预措施: videofluroscopy evaluation of swallowing function (Radiation)

group II: Conventional complete denture

Active Comparator

complete denture construction for edentulous patient and videofluroscopy evaluation

干预措施: videofluroscopy evaluation of swallowing function (Radiation)

group III: Implant overdentutres

Active Comparator

construction of implant overdenture and videofluroscopy evaluation

干预措施: videofluroscopy evaluation of swallowing function (Radiation)

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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