Cost-effectiveness of Implant Treatment for the Edentulous Mandible (CEAIMPLANT)

April 15, 2020 updated by: Cláudio Rodrigues Leles, Universidade Federal de Goias
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single-implant mandibular overdenture
A single midline implant and an O'ring/ball attachment to retain a mandibular overdenture
Device: Single-implant mandibular overdenture
Complete mandibular denture retained by a single midline implant
Other Names:
  • Single-implant overdenture
EXPERIMENTAL: Two-implant mandibular overdenture
Two implants in the canine region and two O'ring/ball attachments to retain a mandibular overdenture
Device: Two-implant mandibular overdenture
Complete mandibular denture retained by two implants in the canine region
Other Names:
  • 2-implant overdenture
EXPERIMENTAL: Fixed mandibular denture
A fixed four-implant mandibular denture
Device: Fixed mandibular denture
A fixed mandibular denture retained by four implants
Other Names:
  • Full-arch mandibular prothesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
1-year
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.
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-year
Cost
Time Frame: 1-year
Direct and indirect treatment costs
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Goias

Investigators

  • Study Chair: Enilza Paiva, PhD, Dean of the Dental School, Federal University of Goias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (ACTUAL)

February 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFG_SAP_41429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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