Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures

Jaw, Edentulous, Partially Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01816425
• Other study ID #: Thermoplastic Denture Base
• Status: Active, not recruiting
• Phase: N/A
• First received: February 20, 2013
• Last updated: March 22, 2013
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• Thermoplastic partial denture

• CoCr partial denture

Locations

Country	Name	City	State
Brazil	Dentistry College, University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No