Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures (Flex)
Primary Purpose
Jaw, Edentulous, Partially
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Thermoplastic partial denture
CoCr partial denture
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Dental Prosthesis, Dental Prosthesis Design
Eligibility Criteria
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
Sites / Locations
- Dentistry College, University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
thermoplastic partial denture
CoCr partial denture
Arm Description
The patients that need oral rehabilitation with partial denture will receive a thermoplastic partial denture as treatment
The patients that need oral rehabilitation with partial denture will receive a CoCr partial denture as treatment
Outcomes
Primary Outcome Measures
Comparison between thermoplastic partial denture and CoCr partial dentures
the 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
Secondary Outcome Measures
Full Information
NCT ID
NCT01816425
First Posted
February 20, 2013
Last Updated
March 22, 2013
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01816425
Brief Title
Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures
Acronym
Flex
Official Title
Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures: Random Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
Dental Prosthesis, Dental Prosthesis Design
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thermoplastic partial denture
Arm Type
Experimental
Arm Description
The patients that need oral rehabilitation with partial denture will receive a thermoplastic partial denture as treatment
Arm Title
CoCr partial denture
Arm Type
Active Comparator
Arm Description
The patients that need oral rehabilitation with partial denture will receive a CoCr partial denture as treatment
Intervention Type
Device
Intervention Name(s)
Thermoplastic partial denture
Intervention Type
Device
Intervention Name(s)
CoCr partial denture
Primary Outcome Measure Information:
Title
Comparison between thermoplastic partial denture and CoCr partial dentures
Description
the 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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto C Stegun, Phd
Organizational Affiliation
Dentistry College, University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dentistry College, University of São Paulo
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
8103801
Citation
VandenBrink JP, Wolfaardt JF, Faulkner MG. A comparison of various removable partial denture clasp materials and fabrication procedure for placing clasps on canine and premolar teeth. J Prosthet Dent. 1993 Aug;70(2):180-8. doi: 10.1016/0022-3913(93)90016-h.
Results Reference
background
PubMed Identifier
14668760
Citation
Wu JC, Latta GH Jr, Wicks RA, Swords RL, Scarbecz M. In vitro deformation of acetyl resin and metal alloy removable partial denture direct retainers. J Prosthet Dent. 2003 Dec;90(6):586-90. doi: 10.1016/j.prosdent.2003.09.020.
Results Reference
background
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Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures
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