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
  Purpose

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.


Condition Intervention
Dentures
Device: Denture teeth

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Wear Characteristics of Nano-Hybrid Denture Teeth

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: August 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nano Hybrid Composite Denture teeth
Denture teeth are made of nano hybrid composite material
Device: Denture teeth
Denture teeth made of nano hybrid composite material
Other Name: Ivoclar Vivadent Inc. SR Phonares denture teeth

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188226

Locations
United States, California
UCLA School of Dentistry
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Ivoclar Vivadent AG
  More Information

No publications provided

Responsible Party: Neal Garrett, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01188226     History of Changes
Other Study ID Numbers: 20101960
Study First Received: August 24, 2010
Last Updated: August 24, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014