跳至主要内容
临床试验/NCT03056976
NCT03056976已完成不适用

Cost-effectiveness of Implant Treatment for the Edentulous Mandible

Universidade Federal de Goias0 个研究点目标入组 37 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
主要终点
Satisfaction with the dentures

研究概览

简要总结

The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants and the mandibular fixed prosthesis retained by four implants, based on a randomized clinical trial.

详细描述

This randomized clinical trial alongside a cost-effectiveness analysis will include 48 edentulous individuals who meet eligibility criteria. Participants will receive conventional complete denture treatment and will be randomized into three groups: single-implant mandibular overdenture group, mandibular overdenture retained by two implants, and fixed mandibular prosthodontics retained by four implants. CBCT and panoramic radiographs will be obtained to assess if bone sites in three-dimensional terms have a minimum volume for receiving implants of at least 3.75 x 9 mm. All patients will receive Titamax IT Cortical implants (Neodent, Curitiba, Brasil) and correspondent prosthodontic components - O'ring/ball abutments for overdentures. Satisfaction with the dentures and oral health-related quality of life impacts will be considered the measures of effectiveness for the three interventions. Cost assessment and cost-effectiveness analysis will be performed from the healthcare provider perspective. Further analysis will be performed using the patient's perspective, in which the costs will be estimated according to the reference price of dental procedures and treatments of the Brazilian Dental Association (Hierarchical Brazilian Classification of Dental Procedures - CBHPO) and the gross costs will be obtained from a panel of experts. Quantification and costing of the resources will be carried out in three steps: identification of the relevant costs to the assessment; measurement of the resources used; and valuation of the resources. The costs will be calculated in Brazilian currency for each patient until one year after treatment. Incremental cost-effectiveness ratios will be calculated to assess the incremental cost for each unit of effectiveness.

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

性别
All
接受健康志愿者

入选标准

  • No contraindications for implant surgery (mainly related to uncontrolled systemic diseases)
  • Present enough bone volume in the mandible for implant placement without the need of bone augmentation procedures.
  • Be able to understand and answer the questionnaires used in the study
  • Agree to participate by providing a written informed consent.

排除标准

  • Noncompliant participants
  • Individuals who do not agree to be randomly allocated to the treatment study group
  • Presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments

结局指标

主要结局

Satisfaction with the dentures

时间窗: 1-year

A 10 cm uninterrupted visual analogue scale will be used in order to assess the participants' ratings of their satisfaction with the upper and lower dentures in relation to the parameters "general satisfaction", "comfort", "stability", "aesthetics", "ability to speak" and "ability to chew".

Oral health-related quality of life impacts

时间窗: 1-year

Oral Health Impact Profile Instrument for edentulous subjects (OHIP-EDENT) in order to assess the impact of oral health conditions on quality of life of participants.

次要结局

  • Masticatory efficiency(1-year)
  • Cost(1-year)

研究者

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

Cláudio Rodrigues Leles

Associate Professor

Universidade Federal de Goias

相似试验