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Completed

NCT Number: NCT03056976

Cost-effectiveness of Implant Treatment for the Edentulous Mandible

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Single-implant mandibular overdenture

Device

Complete mandibular denture retained by a single midline implant

Other names: Single-implant overdenture

Two-implant mandibular overdenture

Device

Complete mandibular denture retained by two implants in the canine region

Other names: 2-implant overdenture

Fixed mandibular denture

Device

A fixed mandibular denture retained by four implants

Other names: Full-arch mandibular prothesis

Primary outcomes

  1. Satisfaction with the dentures

    Time frame: 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".

  2. Oral health-related quality of life impacts

    Time frame: 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.

Secondary outcomes

  1. Masticatory efficiency

    Time frame: 1-year

    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.

  2. Cost

    Time frame: 1-year

    Direct and indirect treatment costs

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Registry information

Acronym: CEAIMPLANT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2017
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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