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Wear Characteristics of Denture Teeth

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ClinicalTrials.gov Identifier: NCT01188226
Recruitment Status : Terminated (Enrollment difficulties and drop outs)
First Posted : August 25, 2010
Results First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Collaborator:
Ivoclar Vivadent AG
Information provided by (Responsible Party):
Neal Garrett, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE August 24, 2010
First Posted Date  ICMJE August 25, 2010
Results First Submitted Date  ICMJE March 15, 2016
Results First Posted Date  ICMJE June 10, 2016
Last Update Posted Date June 10, 2016
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Location of Posterior Denture Tooth Wear [ Time Frame: 6 months after denture completion ]
    Clinical evaluation of posterior wear location (right, left, equal).
  • Location of Posterior Denture Tooth Wear [ Time Frame: 12 months after denture completion ]
    Clinical evaluation of posterior wear location (right, left, equal)
  • Location of Posterior Denture Tooth Wear [ Time Frame: 18 months after denture completion ]
    Clinical evaluation of posterior wear location (right, left, equal)
  • Location of Posterior Denture Tooth Wear [ Time Frame: 24 months after denture completion ]
    Clinical evaluation of posterior wear location (right, left, equal)
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
  • denture tooth wear [ Time Frame: 6 months after denture completion ]
  • denture tooth wear [ Time Frame: 12 months after denture completion ]
  • denture tooth wear [ Time Frame: 18 months after denture completion ]
  • denture tooth wear [ Time Frame: 24 months after denture completion ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Denture Teeth Esthetics [ Time Frame: 6 months after denture completion ]
    Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
  • Amount of Denture Teeth Plaque [ Time Frame: 6 months after denture completion ]
    Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)
  • Denture Teeth Calculus [ Time Frame: 6 months after denture completion ]
    Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)
  • Denture Teeth Esthetics [ Time Frame: 12 months after denture completion ]
    Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)
  • Denture Teeth Esthetics [ Time Frame: 18 months after denture completion ]
    Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
  • Denture Teeth Esthetics [ Time Frame: 24 months after denture completion ]
    Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
  • Amount of Denture Teeth Plaque [ Time Frame: 12 months after denture completion ]
    Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)
  • Amount of Denture Teeth Plaque [ Time Frame: 18 months after denture completion ]
    Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)
  • Amount of Denture Teeth Plaque [ Time Frame: 24 months after denture completion ]
    Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)
  • Denture Teeth Calculus [ Time Frame: 12 months after denture completion ]
    Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)
  • Denture Teeth Calculus [ Time Frame: 18 months after denture completion ]
    Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)
  • Denture Teeth Calculus [ Time Frame: 24 months after denture completion ]
    Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
  • Denture Teeth Esthetics [ Time Frame: 6 months after denture completion ]
  • denture teeth plaque [ Time Frame: 6 months after denture completion ]
  • Denture Teeth Calculus [ Time Frame: 6 months after denture completion ]
  • Denture Teeth Esthetics [ Time Frame: 12 months after denture completion ]
  • Denture Teeth Esthetics [ Time Frame: 18 months after denture completion ]
  • Denture Teeth Esthetics [ Time Frame: 24 months after denture completion ]
  • denture teeth plaque [ Time Frame: 12 months after denture completion ]
  • denture teeth plaque [ Time Frame: 18 months after denture completion ]
  • denture teeth plaque [ Time Frame: 24 months after denture completion ]
  • Denture Teeth Calculus [ Time Frame: 12 months after denture completion ]
  • Denture Teeth Calculus [ Time Frame: 18 months after denture completion ]
  • Denture Teeth Calculus [ Time Frame: 24 months after denture completion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Wear Characteristics of Denture Teeth
Official Title  ICMJE Evaluation of Wear Characteristics of Nano-Hybrid Denture Teeth
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dentures
Intervention  ICMJE Device: Denture teeth
Denture teeth made of nano hybrid composite material
Other Name: Ivoclar Vivadent Inc. SR Phonares denture teeth
Study Arms  ICMJE Experimental: Nano Hybrid Composite Denture teeth
Denture teeth are made of nano hybrid composite material
Intervention: Device: Denture teeth
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 4, 2016)
10
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2010)
24
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01188226
Other Study ID Numbers  ICMJE 20101960
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neal Garrett, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Ivoclar Vivadent AG
Investigators  ICMJE
Principal Investigator: Neal Garret, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date May 2016

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