跳至主要内容
临床试验/NCT04701970
NCT04701970已完成不适用

Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution Using T- Scan System (A Cross-over Clinical Study)

National Research Centre, Egypt1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
assessment of the effect of relining of mandibular complete dentures with soft relining material on occlusal force distribution using T-Scan system. load distribution for 50 completely edentulous patient before and after complete denture relining

研究概览

简要总结

evaluation of occlusal force distribution was carried out with the aid of T-Scan device (Tekscan Inc., South Boston, MA, USA) for mandibular complete dentures before and after relining with long term soft liner for controlled type 2 diabetic patients.

详细描述

A crossover clinical study was carried out with previously constructed and used conventional complete dentures before relining with soft denture liners and then with the same dentures after relining with soft denture liners. The study sample included 50 males completely edentulous contributors, All patients were controlled type 2 diabetes during the study period. All selected patients had previously constructed and used conventional heat cured acrylic resin complete dentures for not less than two years with history of retention and stability problems of mandibular dentures. Mandibular complete dentures had received the essential prosthetic adjustments aiming to achieve optimal retention, maximum stability and the necessary occlusal contacts. The first occlusal parameters were recorded before denture relining. Relining of mandibular dentures was performed and Patients were comfortably using their relined mandibular complete dentures for at least three months and the retention and stability of the conventional dentures were assessed before second recording of occlusal parameter. The evaluation of occlusal force distribution was carried out with the aid of T-Scan device (Tekscan Inc., South Boston, MA, USA). The first record was recorded before denture relining and the second record was three months after denture relining

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
49 Years 至 63 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • All patients were controlled type 2 diabetes
  • All patients were non-smokers
  • had an Angle class I maxillo-mandibular relationship.
  • Patients having moderately developed maxillary and mandibular alveolar ridges lined with firm mucoperiostea.

排除标准

  • history of temporomandibular disorders, or neuromuscular disorders like; bruxism or severe clenching
  • presence of medical problems or severe chronic diseases
  • any intraoral soft or hard tissue pathology.

结局指标

主要结局

assessment of the effect of relining of mandibular complete dentures with soft relining material on occlusal force distribution using T-Scan system. load distribution for 50 completely edentulous patient before and after complete denture relining

时间窗: for each participant: the complete denture should be worn for three months

Fifty completey edentulous patients having previously constructed and utilized conventional complete dentures were selected for this study. Relining of mandibular complete dentures with soft denture liner was carried out. Distribution of occlusal force was evaluated with the aid of T-Scan device before denture relining and three months after relining. measured before relining of complete denture with soft liner and measured again after complete denture relining.

次要结局

未报告次要终点

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Mostafa Ahmed Ibraheem

associate professor

National Research Centre, Egypt

研究点 (1)

Loading locations...

相似试验