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临床试验/NCT02652403
NCT02652403已完成2 期

Quality of Life, Patient Satisfaction, Quality of Dentures, Masticatory Efficiency, Presence of Temporomandibular Dysfunction and Costs Analysis of Simplified and Conventional Techniques for Complete Denture Fabrication

Universidade Federal do Rio Grande do Norte0 个研究点目标入组 42 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
42
主要终点
Patient satisfaction

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a simplified technique of conventional dentures fabrication, comparing it to a traditional technique, by evaluating the impact of oral health on quality of life, satisfaction of individuals and chewing efficiency as well assessing the quality of prosthetics and TMD. Furthermore, the cost involved in the manufacture of dentures through technique simplified will be compared to the cost involved in the traditional technique.

详细描述

The traditional technique will be conducted through a protocol used by most dental schools in Brazil and described in some clinical trials as a conventional technique for dentures fabrication. On simplified technical functional molding step is deleted, and thus the orientation planes are made directly on the resulting models of the initial molding alginate, and the mounting of the models is performed in semiadjustable articulators random with the aid of an auxiliary table 15 degrees with semiadjustable articulators fixed to the slope. To evaluate the impact on oral health quality of life of individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent) for evaluation of patient satisfaction will use a specific questionnaire assessing the quality of the prostheses will be carried out through a specific exam, to assess the presence of TMD, all subjects will be evaluated through the RDC / TMD, for assessing the efficiency masticatory chewing capsules are used, the costs involved in the manufacture of prostheses will be calculated according to the material consumption used during the making of the prosthesis. All subjects will be assessed before making the prostheses and 90 days after installation of new dentures during this period will be held regular control visits. The data will be evaluated in order descriptive by numbers and proportions, moreover, it will be statistically evaluated by means of suitable tests.

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
Single (Participant)

入排标准

年龄范围
35 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Edentulous individuals for more than one year and total bimaxillary prosthesis users that need a couple of new prostheses.

排除标准

  • •Pathological changes of alveolar ridges, motor problems and systemic diseases that may influence on the individual's adaptation to the prosthesis.

研究组 & 干预措施

Complete conventional dentures

Active Comparator

Complete dentures fabricated by conventional technique.

干预措施: Complete conventional dentures (Device)

Complete simplified dentures

Active Comparator

Complete dentures fabricated by simplified technique

干预措施: Complete simplified dentures (Device)

结局指标

主要结局

Patient satisfaction

时间窗: Three month

Patient satisfaction about complete dentures will be access using a questionnaire that assesses aspects related to overall quality of prosthesis, as well as comfort, aesthetics, retention, phonetics and mastication.

Masticatory efficiency

时间窗: Three months

The evaluation of the masticatory efficiency will be conducted through chewing capsules.

Quality of life

时间窗: Three months

To assess the impact of oral health on quality of life individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent). The inventory shall be applied by a masked examiner.

Quality of life

时间窗: Baseline = day 0

To assess the impact of oral health on quality of life individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent). The inventory shall be applied by a masked examiner.

Patient satisfaction

时间窗: Baseline = day 0

Patient satisfaction about complete dentures will be access using a questionnaire that assesses aspects related to overall quality of prosthesis, as well as comfort, aesthetics, retention, phonetics and mastication.

次要结局

  • Quality of dentures(Three months)
  • Temporomandibular dysfunction(Three month)
  • Costs analysis(Baseline = day 0)
  • Temporomandibular dysfunction(Baseline = day 0)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Luísa de Barros Pascoal

Principal Investigator

Universidade Federal do Rio Grande do Norte

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