Trial Outcomes & Findings for Nobio Clinical Study - Demineralization Prevention With a New Antibacterial Restorative Composite (NCT NCT04059250)
NCT ID: NCT04059250
Last Updated: 2021-03-12
Results Overview
The mineral loss is determined in the laboratory using cross-sectional microhardness testings of the enamel after the 4-weeks wearing period of the gap-model. The overall relative mineral loss, ΔZ, for each sample is calculated by creating a hardness profile curve by plotting normalized volume percent mineral against distance from the outer enamel surface. The area under the curve that represents ΔZ (µm \* vol % mineral) is calculated using Simpson's integration rule.
COMPLETED
NA
25 participants
mineral loss ΔZ is determined after the 4 week wearing period
2021-03-12
Participant Flow
each participant enrolled had TWO flanges (right and left side of the mouth) in her/his removable partial denture; the study design is a split-mouth design - in one side the "Nobio Flange"- the Nobio composite was inserted, one the control side - the "control flange" - the traditional control composite was inserted
Unit of analysis: right or left flange of one denture
Participant milestones
| Measure |
Nobio Flange
On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.
Nobio composite: Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers
|
Traditional Composite Control Flange
On the traditional control composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional control composite.
traditional composite: traditional composite which has no bactericidal activities
|
|---|---|---|
|
Overall Study
STARTED
|
25 25
|
25 25
|
|
Overall Study
COMPLETED
|
25 25
|
25 25
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nobio Clinical Study - Demineralization Prevention With a New Antibacterial Restorative Composite
Baseline characteristics by cohort
| Measure |
All Study Participants
n=25 Participants
All participants received both the Nobio flange and the traditional composite control flange.
On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.
Nobio composite: Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers
On the traditional composite control flange side of the lower same partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite.
traditional composite: traditional composite which has no bactericidal activities
|
|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: mineral loss ΔZ is determined after the 4 week wearing periodPopulation: From the original 25 subjects data of the first 5 subjects were used for a sample size calculation. The sample size calculation determined data from 17 subjects would be needed. To account for loss due to follow-up issues, we recruited 20 subjects. 1 subject did not follow the instructions (required wearing time), 2 sample/data sets could not be retrieved due to Covid-19 shelter-in-place restrictions. Results of the first 5 were not included due to statisticians concerns for clean statistics.
The mineral loss is determined in the laboratory using cross-sectional microhardness testings of the enamel after the 4-weeks wearing period of the gap-model. The overall relative mineral loss, ΔZ, for each sample is calculated by creating a hardness profile curve by plotting normalized volume percent mineral against distance from the outer enamel surface. The area under the curve that represents ΔZ (µm \* vol % mineral) is calculated using Simpson's integration rule.
Outcome measures
| Measure |
Nobio Flange
n=17 Participants
On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.
Nobio composite: Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers
|
Traditional Composite Flange
n=17 Participants
On the traditional composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite.
traditional composite: traditional composite which has no bactericidal activities
|
|---|---|---|
|
Mineral Loss ΔZ
|
235 vol% * μm]
Standard Deviation 354
|
774 vol% * μm]
Standard Deviation 556
|
Adverse Events
Nobio Flange
Traditional Composite Flange
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Peter Rechmann
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place