Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures (Flex)

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

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.

Study Overview

• Status: Unknown
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Device: Thermoplastic partial denture; Device: CoCr partial denture

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05508-000
    • Dentistry College, University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: thermoplastic partial denture; The patients that need oral rehabilitation with partial denture will receive a thermoplastic partial denture as treatment	Device: Thermoplastic partial denture
Active Comparator: CoCr partial denture; The patients that need oral rehabilitation with partial denture will receive a CoCr partial denture as treatment	Device: CoCr partial denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Roberto C Stegun, Phd, Dentistry College, University of São Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): November 1, 2013
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: March 19, 2013
• First Posted (Estimate): March 22, 2013

Study Record Updates

• Last Update Posted (Estimate): March 25, 2013
• Last Update Submitted That Met QC Criteria: March 22, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Dental Prosthesis; Dental Prosthesis Design
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: Thermoplastic Denture Base