Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness Analysis

赞助:

合作者:

信息的提供 (责任方):

Cláudio Rodrigues Leles，Universidade Federal de Goias

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 1, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

April 9, 2017

预计主要完成日期

February 9, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Satisfaction with the dentures[ Time Frame: Changes from baseline to 12 months after the intervention ]

A 100 cm graduated 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". Each participant will indicate their level of satisfaction with each parameter by marking a point along the scale, in which ends mean "unsatisfied" and "satisfied", as it is closer to the beginning or the end of the scale, respectively.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Masticatory efficiency[ Time Frame: Changes from baseline to 12 months after the intervention ]
Masticatory efficiency will be assessed as a secondary outcome using a two-colored chewing gum test and a qualitative and quantitative colourimetric method to measure the color-mixing ability. Participants will be asked to sit upright in a dental chair and to chew the gum on their preferred chewing side for 20 cycles. Visual and electronic analysis of the chewed gums samples will be done according to the classification proposed by Schimmel et al. Analysis will be made by two investigators blinded to the study groups and treatment stage. The software ViewGum (dHAL Software, Kifissia, Greece, www.dhal.com) will be used for electronic colourimetric analysis.
Pain and discomfort[ Time Frame: 24 hours, 7 days and 21 days after surgery ]
A 100 cm graduated visual analog scale will be used to evaluate participants' assessments of pain and discomfort regarding the surgical process. Each participant will indicate their level of pain and discomfort with each parameter by marking a point along
Oral health-related quality of life impacts[ Time Frame: Changes from baseline to 12 months after the intervention ]
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.

描述性信息

简略标题 ^ICMJE

Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness Analysis

正式标题 ^ICMJE

Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness Analysis

简要概况

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

详细说明

This randomized clinical trial alongside a cost-effectiveness analysis will include 48 edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. Then, participants will be randomized into one of the treatment groups: mandibular overdenture retained by two implants group or single-implant mandibular overdenture group. Each participant allocated to the single-implant mandibular overdenture group will then receive a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline, and the mandibular overdenture retained by two implants group will receive two implants of the same specification, in the interphoramen region. A healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. Then, a 3.4mm retentive titanium anchor abutment (Straumann 048.439, Institute Straumann AG, Basel, Switzerland) will be connected and tightened to 35 N.cm with a torque wrench. The matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. Outcomes (satisfaction with the dentures and oral health-related quality of life) will be measured at baseline and at the 6- and 12-month follow-up. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: Comparative effectiveness of two competing strategies for the edentulous mandible using implants
盲法: Interventional
盲法描述:To avoid selection bias and ensure adequate allocation concealment, their treatment group will only be revealed for each participant after the assessment of the baseline outcomes, which will occur after the delivery and regular use of the new set of conventional dentures. Since full blinding for the two interventions is not possible for those involved with treatment management and collection of data, only those collecting and analyzing clinical data from masticatory performance tests will be unaware of the assigned treatment.
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: Mandibular Overdenture
Placement of 1 or 2 implants in the anterior region of the edentulous mandible.

研究工具

Experimental: Single-implant mandibular overdenture
Participants allocated to this group will have an implant placed in the mandibular midline and after 3 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture.
Active Comparator: Two-implant mandibular overdenture
Participants allocated to this group will have two implants placed in the inter-foraminal region after 3 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture.

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 23, 2019

预计主要完成日期

February 9, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - No contraindications for implant surgery (mainly related to uncontrolled systemic diseases) - Present enough bone volume in the mandibular midline area 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. Exclusion Criteria: - 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

性别

参与研究的性别:

All

年龄

最小年龄：N/A ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Brazil

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Cláudio Rodrigues Leles，Universidade Federal de Goias

研究赞助商 ^ICMJE

Universidade Federal de Goias

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

Universidade Federal de Goias

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名