Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures

NCT ID: NCT01816425

Last Updated: 2013-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-07-31

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.

Conditions

Jaw, Edentulous, Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

thermoplastic partial denture

The patients that need oral rehabilitation with partial denture will receive a thermoplastic partial denture as treatment

Group Type: EXPERIMENTAL

Thermoplastic partial denture

Intervention Type: DEVICE

CoCr partial denture

The patients that need oral rehabilitation with partial denture will receive a CoCr partial denture as treatment

Group Type: ACTIVE_COMPARATOR

CoCr partial denture

Intervention Type: DEVICE

Interventions

Thermoplastic partial denture

Intervention Type: DEVICE

CoCr partial denture

Intervention Type: DEVICE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Érico Castaldin Fraga Moreira

Master of Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto C Stegun, Phd

Role: PRINCIPAL_INVESTIGATOR

Dentistry College, University of São Paulo

Locations

Dentistry College, University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 8103801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14668760 (View on PubMed)

Other Identifiers

Thermoplastic Denture Base

Identifier Type: -

Identifier Source: org_study_id