Comparison Between Cobalt-chromium Partial Dentures and Thermoplastic Partial Dentures

NCT01816425 | Unknown

• 1 other identifier: Thermoplastic Denture Base
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Dental Prosthesis; Dental Prosthesis Design

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

thermoplastic partial denture

EXPERIMENTAL

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

Device: Thermoplastic partial denture

CoCr partial denture

ACTIVE COMPARATOR

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

Device: CoCr partial denture

Interventions

Thermoplastic partial denture DEVICE

thermoplastic partial denture

CoCr partial denture DEVICE

CoCr partial denture

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patient younger than 60 years patient with edentulous mouth

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Dentistry College, University of São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

Related 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. doi: 10.1016/0022-3913(93)90016-h.

  PMID: 8103801 BACKGROUND

• 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.

  PMID: 14668760 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Roberto C Stegun, Phd

  Dentistry College, University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: March 22, 2013
• Study Start: February 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: July 1, 2014
• Last Updated: March 25, 2013

Record last verified: 2013-03

Locations

BR (1)