Wear Characteristics of Denture Teeth

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ivoclar Vivadent AG
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01188226
First received: August 24, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

August 24, 2010
August 24, 2010
August 2010
December 2012   (final data collection date for primary outcome measure)
  • denture tooth wear [ Time Frame: 6 months after denture completion ] [ Designated as safety issue: No ]
  • denture tooth wear [ Time Frame: 12 months after denture completion ] [ Designated as safety issue: No ]
  • denture tooth wear [ Time Frame: 18 months after denture completion ] [ Designated as safety issue: No ]
  • denture tooth wear [ Time Frame: 24 months after denture completion ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • denture teeth esthetics [ Time Frame: 6 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth plaque [ Time Frame: 6 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth calculus [ Time Frame: 6 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth esthetics [ Time Frame: 12 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth esthetics [ Time Frame: 18 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth esthetics [ Time Frame: 24 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth plaque [ Time Frame: 12 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth plaque [ Time Frame: 18 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth plaque [ Time Frame: 24 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth calculus [ Time Frame: 12 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth calculus [ Time Frame: 18 months after denture completion ] [ Designated as safety issue: No ]
  • denture teeth calculus [ Time Frame: 24 months after denture completion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Wear Characteristics of Denture Teeth
Evaluation of Wear Characteristics of Nano-Hybrid Denture Teeth

The majority of teeth utilized in the fabrication of conventional complete dentures are made of acrylic resins. These acrylic teeth provide increased bond strength to the denture base and are much easier to adjust for correct denture occlusion compared to teeth made of harder materials, such as porcelain. However, the acrylic teeth will wear faster than the porcelain teeth, leading to alterations in how the teeth contact each other if the denture is not replaced periodically (typically every 5-8 years). With the increase in biting and chewing forces that can be achieved during function with dentures supported by dental implants, the rate of tooth wear may be increased, leading to more frequent need for replacement of the prosthesis. Acrylic teeth made of nano hybrid composite material (NHC) potentially offer greater wear resistance and aesthetic characteristics. The NHC teeth employ a wide range of fillers, including highly cross-linked organic macrofillers, high-density inorganic microfillers and silanized silica based nanofillers. The macrofillers are, to a large part, responsible for the adequate strength and color-stability of the teeth, whereas the microfillers improve the wear resistance. The nanofillers offer fundamentally different optical behaviour from those of larger fillers, improving light reflection without lowering the translucency. This offers additional opportunities in the development of composite teeth, which have to exhibit lifelike aesthetics and translucency. These teeth made of nano-particles and hybrid composites can be made with two different techniques, one where the materials are pressed together and another using an injection technique. The injection method has been found to have better aesthetic results, but resistance to wear in clinical use has not been established.

The purpose of this study is to evaluate the wear characteristics of new resin denture teeth (nano particles - hybrid composite) made by an injection technique. Twenty-four edentulous subjects will be enrolled who have completed implant placement for mandibular implant overdentures opposing a maxillary complete denture or implant overdenture, or patients that have previously received these dentures and are interested in having new dentures. Both maxillary and mandibular dentures will be fabricated using injection molded nano-hybrid composite denture teeth. The wear of denture teeth will be evaluated using stereophotographic recordings at baseline, 6, 12, 18 and 24 months after denture treatment.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dentures
Device: Denture teeth
Denture teeth made of nano hybrid composite material
Other Name: Ivoclar Vivadent Inc. SR Phonares denture teeth
Experimental: Nano Hybrid Composite Denture teeth
Denture teeth are made of nano hybrid composite material
Intervention: Device: Denture teeth
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
24
Not Provided
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Being treated at UCLA School of Dentistry clinics with implant-assisted mandibular overdentures and conventional maxillary complete dentures or implant overdentures
  • Previously treated at UCLA School of Dentistry clinics with implant-assisted mandibular overdentures and conventional maxillary complete dentures or implant overdentures and desires new dentures
  • Have healthy, normal soft and hard oral tissues

Exclusion Criteria:

  • Oral and medical conditions which would interfere with follow-up evaluations over a two-year period after denture treatment completion
  • Abnormal oral soft or hard tissues that prevents conventional denture fabrication
  • Impaired dexterity the prevents proper oral hygiene
  • Allergy to denture base materials
  • Severe parafunction based on current condition of existing dentures
  • Any limitation in mouth opening or closing
  • Severe TMD symptoms
  • Employees (and their immediate families) of the UCLA School of Dentistry
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01188226
20101960
No
Neal Garrett, University of California, Los Angeles
University of California, Los Angeles
Ivoclar Vivadent AG
Not Provided
University of California, Los Angeles
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP