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Wear Characteristics of Denture Teeth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dentures
Intervention Device: Denture teeth
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nano Hybrid Composite Denture Teeth
Hide Arm/Group Description

Denture teeth are made of nano hybrid composite material

Denture teeth: Denture teeth made of nano hybrid composite material

Period Title: Overall Study
Started 10
Completed 6
Not Completed 4
Reason Not Completed
Withdrawal by Subject             4
Arm/Group Title Nano Hybrid Composite Denture Teeth
Hide Arm/Group Description Denture teeth are made of nano hybrid composite material
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
Subjects that signed consent
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  50.0%
>=65 years
5
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Location of Posterior Denture Tooth Wear
Hide Description Clinical evaluation of posterior wear location (right, left, equal).
Time Frame 6 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 6-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Upper Denture Lower Denture
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 8 8
Measure Type: Number
Unit of Measure: participants
Right side wear 0 0
Equal wear 7 6
Left side wear 1 2
2.Primary Outcome
Title Location of Posterior Denture Tooth Wear
Hide Description Clinical evaluation of posterior wear location (right, left, equal)
Time Frame 12 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 12-month follow-up. Upper and lower dentures assessed and reported separately as Arms for this outcome.
Arm/Group Title Upper Denture Lower Denture
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
Right side wear 0 1
Equal wear 6 5
Left side wear 1 1
3.Primary Outcome
Title Location of Posterior Denture Tooth Wear
Hide Description Clinical evaluation of posterior wear location (right, left, equal)
Time Frame 18 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 18-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 18-month lower-denture assessment
Arm/Group Title Upper Denture Lower Denture
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Participants with lower denture in use 18 months after denture completion. Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 4 3
Measure Type: Number
Unit of Measure: participants
Right side 0 0
Equal 3 2
Left side 1 1
4.Primary Outcome
Title Location of Posterior Denture Tooth Wear
Hide Description Clinical evaluation of posterior wear location (right, left, equal)
Time Frame 24 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 24-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 24-month lower-denture assessment
Arm/Group Title Upper Denture Lower Denture
Hide Arm/Group Description:
Participants wearing upper denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
Participants wearing lower denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
Right side 0 0
Equal 5 5
Left side 1 0
5.Secondary Outcome
Title Denture Teeth Esthetics
Hide Description Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Time Frame 6 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Nano Hybrid Composite Dentures
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
Deviation: High 0
Deviation: Little 2
Deviation: None 6
6.Secondary Outcome
Title Amount of Denture Teeth Plaque
Hide Description 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)
Time Frame 6 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Anterior Denture Teeth Right-posterior Denture Teeth Left-posterior Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 8 8 8
Measure Type: Number
Unit of Measure: participants
0=None 5 5 5
1=Soft debris covering ≤1/3 of surface 2 2 2
2=soft debris covering > 1/3 and ≤ ½ of surface 1 1 1
3=soft debris covering more than ½ of surface 0 0 0
7.Secondary Outcome
Title Denture Teeth Calculus
Hide Description 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)
Time Frame 6 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Anterior Denture Teeth Right-posterior Denture Teeth Left-posterior Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 8 8 8
Measure Type: Number
Unit of Measure: participants
0 8 8 8
1 0 0 0
2 0 0 0
3 0 0 0
8.Secondary Outcome
Title Denture Teeth Esthetics
Hide Description Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)
Time Frame 12 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 12-month follow-up.
Arm/Group Title Nano Hybrid Composite Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Deviation: High 1
Deviation: Little 2
Deviation: None 4
9.Secondary Outcome
Title Denture Teeth Esthetics
Hide Description Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Time Frame 18 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 18-month follow-up.
Arm/Group Title Nano Hybrid Composite Denture Teeth
Hide Arm/Group Description:

Denture teeth are made of nano hybrid composite material

Denture teeth: Denture teeth made of nano hybrid composite material

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
Deviation: High 0
Deviation: Little 1
Deviation: None 3
10.Secondary Outcome
Title Denture Teeth Esthetics
Hide Description Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Time Frame 24 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 24-month follow-up.
Arm/Group Title Nano Hybrid Composite Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Deviation: High 1
Deviation: Little 3
Deviation: None 2
11.Secondary Outcome
Title Amount of Denture Teeth Plaque
Hide Description 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)
Time Frame 12 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Anterior Denture Teeth Right-posterior Denture Teeth Left-posterior Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 7 7 7
Measure Type: Number
Unit of Measure: participants
0= none 6 6 5
1 = soft debris covering ≤1/3 of tooth surface 1 1 2
2 = soft debris covering > 1/3 and ≤ ½ of surface 0 0 0
3 = soft debris covering more than ½ of surface 0 0 0
12.Secondary Outcome
Title Amount of Denture Teeth Plaque
Hide Description 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)
Time Frame 18 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Anterior Denture Teeth Right-posterior Denture Teeth Left-posterior Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 4 4 4
Measure Type: Number
Unit of Measure: participants
0 = None 3 4 4
1 = soft debris covering ≤1/3 of tooth surface 1 0 0
2 = soft debris covering > 1/3 and ≤ ½ of surface 0 0 0
3 = soft debris covering more than ½ of surface 0 0 0
13.Secondary Outcome
Title Amount of Denture Teeth Plaque
Hide Description 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)
Time Frame 24 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Anterior Denture Teeth Right-posterior Denture Teeth Left-posterior Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 6 6 6
Measure Type: Number
Unit of Measure: participants
0 = None 5 4 4
1 = soft debris covering ≤1/3 of tooth surface 0 2 2
2 = soft debris covering > 1/3 and ≤ ½ of surface 1 0 0
3 = soft debris covering more than ½ of surface 0 0 0
14.Secondary Outcome
Title Denture Teeth Calculus
Hide Description 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)
Time Frame 12 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Anterior Denture Teeth Right-posterior Denture Teeth Left-posterior Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 7 7 7
Measure Type: Number
Unit of Measure: participants
0 6 6 6
1 1 1 1
2 0 0 0
3 0 0 0
15.Secondary Outcome
Title Denture Teeth Calculus
Hide Description 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)
Time Frame 18 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Anterior Denture Teeth Right-posterior Denture Teeth Left-posterior Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 4 4 4
Measure Type: Number
Unit of Measure: participants
0 4 4 4
1 0 0 0
2 0 0 0
3 0 0 0
16.Secondary Outcome
Title Denture Teeth Calculus
Hide Description 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)
Time Frame 24 months after denture completion
Hide Outcome Measure Data
Hide Analysis Population Description
For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.
Arm/Group Title Anterior Denture Teeth Right-posterior Denture Teeth Left-posterior Denture Teeth
Hide Arm/Group Description:
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Denture teeth are made of nano hybrid composite material
Overall Number of Participants Analyzed 6 6 6
Measure Type: Number
Unit of Measure: participants
0 6 4 4
1 0 2 2
2 0 0 0
3 0 0 0
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nano Hybrid Composite Denture Teeth
Hide Arm/Group Description Denture teeth are made of nano hybrid composite material
All-Cause Mortality
Nano Hybrid Composite Denture Teeth
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Nano Hybrid Composite Denture Teeth
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nano Hybrid Composite Denture Teeth
Affected / at Risk (%) # Events
Total   6/10 (60.00%)    
Gastrointestinal disorders   
Denture tooth fracture [1]  6/10 (60.00%)  11
Lower denture break [2]  1/10 (10.00%)  1
Tooth debonding [3]  1/10 (10.00%) 
[1]
One tooth or multiple teeth fractured and repaired during study
[2]
Lower denture broke at midline and was replaced during the study
[3]
Tooth debonding requiring recementation
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Neal Garrett, MD
Organization: UCLA
EMail: ngarrett@ucla.edu
Layout table for additonal information
Responsible Party: Neal Garrett, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01188226    
Other Study ID Numbers: 20101960
First Submitted: August 24, 2010
First Posted: August 25, 2010
Results First Submitted: March 15, 2016
Results First Posted: June 10, 2016
Last Update Posted: June 10, 2016