Trial Outcomes & Findings for Wear Characteristics of Denture Teeth (NCT NCT01188226)
NCT ID: NCT01188226
Last Updated: 2016-06-10
Results Overview
Clinical evaluation of posterior wear location (right, left, equal).
TERMINATED
NA
10 participants
6 months after denture completion
2016-06-10
Participant Flow
Participant milestones
| Measure |
Nano Hybrid Composite Denture Teeth
Denture teeth are made of nano hybrid composite material
Denture teeth: Denture teeth made of nano hybrid composite material
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Nano Hybrid Composite Denture Teeth
Denture teeth are made of nano hybrid composite material
Denture teeth: Denture teeth made of nano hybrid composite material
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Wear Characteristics of Denture Teeth
Baseline characteristics by cohort
| Measure |
Nano Hybrid Composite Denture Teeth
n=10 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 months after denture completionPopulation: 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.
Clinical evaluation of posterior wear location (right, left, equal).
Outcome measures
| Measure |
Upper Denture
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Location of Posterior Denture Tooth Wear
Right side wear
|
0 participants
|
0 participants
|
—
|
|
Location of Posterior Denture Tooth Wear
Equal wear
|
7 participants
|
6 participants
|
—
|
|
Location of Posterior Denture Tooth Wear
Left side wear
|
1 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: 12 months after denture completionPopulation: For study participants who completed the 12-month follow-up. Upper and lower dentures assessed and reported separately as Arms for this outcome.
Clinical evaluation of posterior wear location (right, left, equal)
Outcome measures
| Measure |
Upper Denture
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Location of Posterior Denture Tooth Wear
Right side wear
|
0 participants
|
1 participants
|
—
|
|
Location of Posterior Denture Tooth Wear
Equal wear
|
6 participants
|
5 participants
|
—
|
|
Location of Posterior Denture Tooth Wear
Left side wear
|
1 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: 18 months after denture completionPopulation: 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
Clinical evaluation of posterior wear location (right, left, equal)
Outcome measures
| Measure |
Upper Denture
n=4 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=3 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Location of Posterior Denture Tooth Wear
Right side
|
0 participants
|
0 participants
|
—
|
|
Location of Posterior Denture Tooth Wear
Equal
|
3 participants
|
2 participants
|
—
|
|
Location of Posterior Denture Tooth Wear
Left side
|
1 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: 24 months after denture completionPopulation: 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
Clinical evaluation of posterior wear location (right, left, equal)
Outcome measures
| Measure |
Upper Denture
n=6 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=5 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Location of Posterior Denture Tooth Wear
Left side
|
1 participants
|
0 participants
|
—
|
|
Location of Posterior Denture Tooth Wear
Right side
|
0 participants
|
0 participants
|
—
|
|
Location of Posterior Denture Tooth Wear
Equal
|
5 participants
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: 6 months after denture completionClinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Outcome measures
| Measure |
Upper Denture
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Denture Teeth Esthetics
Deviation: None
|
6 participants
|
—
|
—
|
|
Denture Teeth Esthetics
Deviation: High
|
0 participants
|
—
|
—
|
|
Denture Teeth Esthetics
Deviation: Little
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months after denture completionPopulation: 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.
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)
Outcome measures
| Measure |
Upper Denture
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Amount of Denture Teeth Plaque
0=None
|
5 participants
|
5 participants
|
5 participants
|
|
Amount of Denture Teeth Plaque
1=Soft debris covering ≤1/3 of surface
|
2 participants
|
2 participants
|
2 participants
|
|
Amount of Denture Teeth Plaque
2=soft debris covering > 1/3 and ≤ ½ of surface
|
1 participants
|
1 participants
|
1 participants
|
|
Amount of Denture Teeth Plaque
3=soft debris covering more than ½ of surface
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months after denture completionPopulation: 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.
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)
Outcome measures
| Measure |
Upper Denture
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
n=8 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Denture Teeth Calculus
0
|
8 participants
|
8 participants
|
8 participants
|
|
Denture Teeth Calculus
1
|
0 participants
|
0 participants
|
0 participants
|
|
Denture Teeth Calculus
2
|
0 participants
|
0 participants
|
0 participants
|
|
Denture Teeth Calculus
3
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 months after denture completionPopulation: For study participants who completed the 12-month follow-up.
Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)
Outcome measures
| Measure |
Upper Denture
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Denture Teeth Esthetics
Deviation: Little
|
2 participants
|
—
|
—
|
|
Denture Teeth Esthetics
Deviation: High
|
1 participants
|
—
|
—
|
|
Denture Teeth Esthetics
Deviation: None
|
4 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 months after denture completionPopulation: For study participants who completed the 18-month follow-up.
Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Outcome measures
| Measure |
Upper Denture
n=4 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Denture Teeth Esthetics
Deviation: High
|
0 participants
|
—
|
—
|
|
Denture Teeth Esthetics
Deviation: Little
|
1 participants
|
—
|
—
|
|
Denture Teeth Esthetics
Deviation: None
|
3 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 months after denture completionPopulation: For study participants who completed the 24-month follow-up.
Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)
Outcome measures
| Measure |
Upper Denture
n=6 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Denture Teeth Esthetics
Deviation: High
|
1 participants
|
—
|
—
|
|
Denture Teeth Esthetics
Deviation: Little
|
3 participants
|
—
|
—
|
|
Denture Teeth Esthetics
Deviation: None
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months after denture completionPopulation: 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.
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)
Outcome measures
| Measure |
Upper Denture
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Amount of Denture Teeth Plaque
0= none
|
6 participants
|
6 participants
|
5 participants
|
|
Amount of Denture Teeth Plaque
1 = soft debris covering ≤1/3 of tooth surface
|
1 participants
|
1 participants
|
2 participants
|
|
Amount of Denture Teeth Plaque
2 = soft debris covering > 1/3 and ≤ ½ of surface
|
0 participants
|
0 participants
|
0 participants
|
|
Amount of Denture Teeth Plaque
3 = soft debris covering more than ½ of surface
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 18 months after denture completionPopulation: 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.
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)
Outcome measures
| Measure |
Upper Denture
n=4 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=4 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
n=4 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Amount of Denture Teeth Plaque
0 = None
|
3 participants
|
4 participants
|
4 participants
|
|
Amount of Denture Teeth Plaque
1 = soft debris covering ≤1/3 of tooth surface
|
1 participants
|
0 participants
|
0 participants
|
|
Amount of Denture Teeth Plaque
2 = soft debris covering > 1/3 and ≤ ½ of surface
|
0 participants
|
0 participants
|
0 participants
|
|
Amount of Denture Teeth Plaque
3 = soft debris covering more than ½ of surface
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 months after denture completionPopulation: 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.
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)
Outcome measures
| Measure |
Upper Denture
n=6 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=6 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
n=6 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Amount of Denture Teeth Plaque
0 = None
|
5 participants
|
4 participants
|
4 participants
|
|
Amount of Denture Teeth Plaque
1 = soft debris covering ≤1/3 of tooth surface
|
0 participants
|
2 participants
|
2 participants
|
|
Amount of Denture Teeth Plaque
2 = soft debris covering > 1/3 and ≤ ½ of surface
|
1 participants
|
0 participants
|
0 participants
|
|
Amount of Denture Teeth Plaque
3 = soft debris covering more than ½ of surface
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 months after denture completionPopulation: 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.
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)
Outcome measures
| Measure |
Upper Denture
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
n=7 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Denture Teeth Calculus
0
|
6 participants
|
6 participants
|
6 participants
|
|
Denture Teeth Calculus
1
|
1 participants
|
1 participants
|
1 participants
|
|
Denture Teeth Calculus
2
|
0 participants
|
0 participants
|
0 participants
|
|
Denture Teeth Calculus
3
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 18 months after denture completionPopulation: 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.
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)
Outcome measures
| Measure |
Upper Denture
n=4 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=4 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
n=4 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Denture Teeth Calculus
0
|
4 participants
|
4 participants
|
4 participants
|
|
Denture Teeth Calculus
1
|
0 participants
|
0 participants
|
0 participants
|
|
Denture Teeth Calculus
2
|
0 participants
|
0 participants
|
0 participants
|
|
Denture Teeth Calculus
3
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 months after denture completionPopulation: 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.
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)
Outcome measures
| Measure |
Upper Denture
n=6 Participants
Denture teeth are made of nano hybrid composite material
|
Lower Denture
n=6 Participants
Denture teeth are made of nano hybrid composite material
|
Left-posterior Denture Teeth
n=6 Participants
Denture teeth are made of nano hybrid composite material
|
|---|---|---|---|
|
Denture Teeth Calculus
1
|
0 participants
|
2 participants
|
2 participants
|
|
Denture Teeth Calculus
0
|
6 participants
|
4 participants
|
4 participants
|
|
Denture Teeth Calculus
2
|
0 participants
|
0 participants
|
0 participants
|
|
Denture Teeth Calculus
3
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Nano Hybrid Composite Denture Teeth
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nano Hybrid Composite Denture Teeth
n=10 participants at risk
Denture teeth are made of nano hybrid composite material
|
|---|---|
|
Gastrointestinal disorders
Denture tooth fracture
|
60.0%
6/10 • Number of events 11 • 24 months
|
|
Gastrointestinal disorders
Lower denture break
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Tooth debonding
|
10.0%
1/10 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place