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Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures

Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures: Random Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01816425
Acronym
Flex
Enrollment
50
Registered
2013-03-22
Start date
2012-02-29
Completion date
2014-07-31
Last updated
2013-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw, Edentulous, Partially

Keywords

Dental Prosthesis, Dental Prosthesis Design

Brief summary

The cobalt-chromium (CoCr) partial denture has been made for a long period. It respects biomechanical principles, providing harmony between mechanical and biological activities. The fundamental principles of biomechanics applied in the manufacture of steel structure are: retention, reciprocity, attachment and stability. To get the proper planning, we need to assess the dental support system, with its qualitative and quantitative values. But conventional dentures has a inherent problem which is the metallic elements apparent and in some cases the stiffness of the component support elements that generates stress. The Thermoplastic partial dentures increase aesthetics in replacement of metal structures in oral rehabilitation. So many treatments are being done in everyday practice without a defined concept on various aspects of its construction and oral applicability. This trial aims to assess the basic parameters of both dentures in: nutrition, speech therapy, chewing force, chewing efficiency and quality of life. 60 years old or older patients who require removable prosthesis. These will be randomly selected for the fabrication and installation of removable partial dentures (Gold Standard - control group - CoCr partial denture) and thermoplastic partial denture(experimental group). Before beginning the work, selected patients will make some preliminary tests such as controlling the individual condition, they are: * three questionnaires: * instrument for assessing quality of life related to oral health, GOHAI - General Oral Health Assessment Index of Atchinson & Dolan * instrument for assessing the social and economic profile of ABEP (Brazilian Association of Research Companies) CCEB 2011; * Instrument for assessing cognitive condition MINI-MENTAL; * Speech evaluation * Nutritional assessment; * Evaluation of masticatory efficiency and * Chewing strength. After preliminary assessments patients will be subjected to treatments for manufacture of partial dentures. After the installation (end of the technical construction of the dentures) and the adjustments appointment the tests will be repeated and in successive control periods of 3 months, 6 months, 12 months, 18 months and 24 months respectively, when the tests will do again now to see if there was a change in the initial condition.

Interventions

DEVICEThermoplastic partial denture
DEVICECoCr partial denture

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

60 years old or older patient with partial edentulous jaws with indication of removable partial denture

Exclusion criteria

patient younger than 60 years patient with edentulous mouth

Design outcomes

Primary

MeasureTime frameDescription
Comparison between thermoplastic partial denture and CoCr partial dentures24 monthsthe tests result of the thermoplastic partial denture will be compared with the tests result of the CoCr partial dentures, the hypothesis is that thermoplastic partial denture are similar to CoCr partial dentures

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026