Trial Outcomes & Findings for Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant (NCT NCT03306433)
NCT ID: NCT03306433
Last Updated: 2021-10-07
Results Overview
The mineral density immediately below the surface of the tooth will lower if left unprotected to some extent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Visit Window: 3-4 weeks.
Results posted on
2021-10-07
Participant Flow
Recruitment began in January 2018 and ended in October 2018. Participants were recruited from the patient pool at the University of Colorado School of Dental Medicine Department of Orthodontics. Eligible candidates were offered the opportunity to participate in the study.
Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations.
Participant milestones
| Measure |
All Participants
Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations. Enrolled participants were assigned to receive up to all three treatments. There were 16 participant total. Treatments included:
UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
The adhesive used to bond the orthodontic bracket to the tooth UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
UDMA-K18
|
12
|
|
Overall Study
Adhesive Control
|
12
|
|
Overall Study
UDMA-control
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
All Participants
Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations. Enrolled participants were assigned to receive up to all three treatments. There were 16 participant total. Treatments included:
UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
The adhesive used to bond the orthodontic bracket to the tooth UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Patient did not have teeth extracted
|
1
|
|
Overall Study
Teeth not sent to the lab or participant only had two teeth for extraction
|
3
|
Baseline Characteristics
Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant
Baseline characteristics by cohort
| Measure |
All Participants
n=16 Participants
Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations. All 16 participants had all three treatments. Thus there were 16 participant total. Treatments included:
UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
The adhesive used to bond the orthodontic bracket to the tooth UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
|
|---|---|
|
Age, Continuous
Age
|
13.8 Years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
|
Canary Score
|
7 Canary Numbers
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit Window: 3-4 weeks.Population: In this split mouth (same mouth) design all participants receive all treatments.
The mineral density immediately below the surface of the tooth will lower if left unprotected to some extent.
Outcome measures
| Measure |
UDMA-K18
n=12 Participants
UDMA-K18 smooth surface sealant
UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
|
UDMA-control
n=9 Participants
UDMA smooth surface sealant without K18
UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
|
Adhesive Control
n=12 Participants
The adhesive used to bond the orthodontic bracket to the tooth
|
|---|---|---|---|
|
Change in Mineral Density Determined by the Canary Caries Detection System
|
23.424 Canary Number
Standard Deviation 3.288
|
31.125 Canary Number
Standard Deviation 4.275
|
35.563 Canary Number
Standard Deviation 7.378
|
SECONDARY outcome
Timeframe: Visit Window: 3-4 weeks.Population: Split mouth design : All participants received all treatments
The WSL Index is from 0 (no lesion) to 4 (severe lesion)
Outcome measures
| Measure |
UDMA-K18
n=12 Participants
UDMA-K18 smooth surface sealant
UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
|
UDMA-control
n=9 Participants
UDMA smooth surface sealant without K18
UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
|
Adhesive Control
n=12 Participants
The adhesive used to bond the orthodontic bracket to the tooth
|
|---|---|---|---|
|
White Spot Lesion (WSL) Index
|
0 White spot Index
Interval 0.0 to 2.0
|
2 White spot Index
Interval 0.0 to 2.0
|
2 White spot Index
Interval 1.0 to 3.0
|
Adverse Events
UDMA-K18
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UDMA-control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adhesive Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place