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Wear Characteristics of Denture Teeth

This study has been terminated.
(Enrollment difficulties and drop outs)
Sponsor:
Collaborator:
Ivoclar Vivadent AG
Information provided by (Responsible Party):
Neal Garrett, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01188226
First received: August 24, 2010
Last updated: May 4, 2016
Last verified: May 2016
Results First Received: March 15, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dentures
Intervention: Device: Denture teeth

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Nano Hybrid Composite Denture Teeth

Denture teeth are made of nano hybrid composite material

Denture teeth: Denture teeth made of nano hybrid composite material


Participant Flow:   Overall Study
    Nano Hybrid Composite Denture Teeth  
STARTED     10  
COMPLETED     6  
NOT COMPLETED     4  
Withdrawal by Subject                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects that signed consent

Reporting Groups
  Description
Nano Hybrid Composite Denture Teeth Denture teeth are made of nano hybrid composite material

Baseline Measures
    Nano Hybrid Composite Denture Teeth  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     5  
Gender  
[units: participants]
 
Female     5  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Location of Posterior Denture Tooth Wear   [ Time Frame: 6 months after denture completion ]

2.  Primary:   Location of Posterior Denture Tooth Wear   [ Time Frame: 12 months after denture completion ]

3.  Primary:   Location of Posterior Denture Tooth Wear   [ Time Frame: 18 months after denture completion ]

4.  Primary:   Location of Posterior Denture Tooth Wear   [ Time Frame: 24 months after denture completion ]

5.  Secondary:   Denture Teeth Esthetics   [ Time Frame: 6 months after denture completion ]

6.  Secondary:   Amount of Denture Teeth Plaque   [ Time Frame: 6 months after denture completion ]

7.  Secondary:   Denture Teeth Calculus   [ Time Frame: 6 months after denture completion ]

8.  Secondary:   Denture Teeth Esthetics   [ Time Frame: 12 months after denture completion ]

9.  Secondary:   Denture Teeth Esthetics   [ Time Frame: 18 months after denture completion ]

10.  Secondary:   Denture Teeth Esthetics   [ Time Frame: 24 months after denture completion ]

11.  Secondary:   Amount of Denture Teeth Plaque   [ Time Frame: 12 months after denture completion ]

12.  Secondary:   Amount of Denture Teeth Plaque   [ Time Frame: 18 months after denture completion ]

13.  Secondary:   Amount of Denture Teeth Plaque   [ Time Frame: 24 months after denture completion ]

14.  Secondary:   Denture Teeth Calculus   [ Time Frame: 12 months after denture completion ]

15.  Secondary:   Denture Teeth Calculus   [ Time Frame: 18 months after denture completion ]

16.  Secondary:   Denture Teeth Calculus   [ Time Frame: 24 months after denture completion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Neal Garrett, MD
Organization: UCLA
e-mail: ngarrett@ucla.edu



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
Results First Received: March 15, 2016
Last Updated: May 4, 2016
Health Authority: United States: Institutional Review Board