Status:
COMPLETED
Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture
Lead Sponsor:
Universidade Federal de Goias
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Mouth, Edentulous
Complete Edentulism
Eligibility:
All Genders
Phase:
NA
Brief Summary
This is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular...
Detailed Description
This randomized clinical trial alongside a cost-effectiveness analysis will include edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for a...
Eligibility Criteria
Inclusion
- To present favorable general health and the need to be rehabilitated with a new set of complete dentures
- To agree to be randomly assigned to one of the two study groups
- To be able to comprehend and answer the data collection instruments.
Exclusion
- Presence of general health conditions that may contraindicate implant surgery (such as uncontrolled type II diabetes mellitus or uncontrolled cardiovascular conditions)
- Insufficient height and volume in the midline region to receive an implant of at least 3.75mm x 9.0mm
- Presence of evident signs of cognitive impairment and/or oral conditions requiring additional treatments, such as oral lesions and temporomandibular disorders
- Inability to attend to the scheduled appointments and follow-up visits
Key Trial Info
Start Date :
March 10 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03463174
Start Date
March 10 2015
End Date
October 31 2017
Last Update
March 13 2018
Active Locations (1)
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1
School of Dentistry, Federal University of Goias
Goiânia, Goiás, Brazil, 74605-220