Trial Outcomes & Findings for MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study (NCT NCT02424097)
NCT ID: NCT02424097
Last Updated: 2020-04-22
Results Overview
The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering \<50% of the area, 2 = decalcification covering \> 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12. 16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192. A mean over all participants in one group was calculated. A higher score means a worse outcome.
COMPLETED
PHASE4
40 participants
Baseline and 12-months
2020-04-22
Participant Flow
Participant milestones
| Measure |
MI Paste & MI Varnish
MI past will be applied by the patient every night; MI varnish will be applied every three months in the office
CPP-ACP 5% sodium fluoride varnish \& 900ppm fluoride paste: MI Paste \& MI Varnish- in-office:
varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)
\- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray
|
Standard of Care
Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended
1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
MI Paste & MI Varnish
MI past will be applied by the patient every night; MI varnish will be applied every three months in the office
CPP-ACP 5% sodium fluoride varnish \& 900ppm fluoride paste: MI Paste \& MI Varnish- in-office:
varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)
\- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray
|
Standard of Care
Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended
1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study
Baseline characteristics by cohort
| Measure |
MI Paste & MI Varnish
n=20 Participants
MI past will be applied by the patient every night; MI varnish will be applied every three months in the office
CPP-ACP 5% sodium fluoride varnish \& 900ppm fluoride paste: MI Paste \& MI Varnish- in-office:
varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)
\- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray
|
Standard of Care
n=20 Participants
Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended
1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
15.1 years
STANDARD_DEVIATION 3.8 • n=99 Participants
|
16.5 years
STANDARD_DEVIATION 3.8 • n=107 Participants
|
16.1 years
STANDARD_DEVIATION 3.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12-monthsPopulation: enamel decalcification index (EDI)
The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering \<50% of the area, 2 = decalcification covering \> 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12. 16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192. A mean over all participants in one group was calculated. A higher score means a worse outcome.
Outcome measures
| Measure |
MI Paste & MI Varnish
n=19 Participants
MI past will be applied by the patient every night; MI varnish will be applied every three months in the office
CPP-ACP 5% sodium fluoride varnish \& 900ppm fluoride paste: MI Paste \& MI Varnish- in-office:
varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)
\- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray
|
Standard of Care
n=18 Participants
Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended
1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)
|
|---|---|---|
|
Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)
|
40.2 units on a scale
Standard Deviation 13.6
|
41.3 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline and 12-monthsThe International Caries Detection and Assessment System (ICDAS II) is a standardized method of caries lesion assessment.The score is based on apparent lesion severity, with scores from 0 to 6.The buccal surface of each tooth was divided into 4 quadrants, and for each quadrant a score was assigned with ICDAS scores: 0 = sound, 1 = first visual change in enamel, after air drying, 2 = distinct demineralization visual change in enamel, 3 = localized enamel breakdown due to caries with no visible dentin, 4 = surface with underlying dark shadow from dentin with or without enamel breakdown, 5 = distinct cavity with visible dentin, 6 = extensive cavity with visible dentin. The ICDAS scores were calculated as the sum of the highest ICDAS scores assigned to each examined tooth per subject. 16 teeth per subject were evaluated, thus, for each subject the value can range between 0 and 96. A mean over all participants in one group was calculated. A higher score means a worse outcome.
Outcome measures
| Measure |
MI Paste & MI Varnish
n=19 Participants
MI past will be applied by the patient every night; MI varnish will be applied every three months in the office
CPP-ACP 5% sodium fluoride varnish \& 900ppm fluoride paste: MI Paste \& MI Varnish- in-office:
varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)
\- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray
|
Standard of Care
n=18 Participants
Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended
1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)
|
|---|---|---|
|
Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)
|
22.3 score on a scale
Standard Deviation 5.9
|
22.6 score on a scale
Standard Deviation 4.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-monthsWS lesion activity will be determined using the Nyvad criteria;
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-monthsfluorescence measurements using blue light fluorescence make WSLs visible for scoring;
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-monthsQuantitative Light Fluorescence will be used to evaluate the WSL
Outcome measures
Outcome data not reported
Adverse Events
MI Paste & MI Varnish
Standard of Care
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