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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056976
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Cláudio Rodrigues Leles, Universidade Federal de Goias

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Edentulous Mouth Device: Single-implant mandibular overdenture Device: Two-implant mandibular overdenture Device: Fixed mandibular denture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparative effectiveness of thre competing strategies for the edentulous mandible using implants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cost-effectiveness of Implant Treatment for the Edentulous Mandible
Study Start Date : July 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

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 Name: 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 Name: 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 Name: Full-arch mandibular prothesis




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056976


Sponsors and Collaborators
Universidade Federal de Goias
Investigators
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Study Chair: Enilza Paiva, PhD Dean of the Dental School, Federal University of Goias
Publications:
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Responsible Party: Cláudio Rodrigues Leles, Associate Professor, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT03056976    
Other Study ID Numbers: UFG_SAP_41429
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cláudio Rodrigues Leles, Universidade Federal de Goias:
Overdenture
Dental implant
Complete denture
Cost analysis
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases