Trial Outcomes & Findings for MI Varnish for the Prevention of White Spot Lesions (NCT NCT03446690)
NCT ID: NCT03446690
Last Updated: 2023-06-26
Results Overview
Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.
COMPLETED
PHASE4
62 participants
Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.
2023-06-26
Participant Flow
Participant milestones
| Measure |
MI Varnish Group
33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. 29 subjects were recruited retrospectively from a previous study and the results compared.
MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.
|
Control Group
A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group.
Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
29
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MI Varnish for the Prevention of White Spot Lesions
Baseline characteristics by cohort
| Measure |
MI Varnish Group
n=26 Participants
33 subjects were prospectively recruited for the project in the MI Varnish group. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, UAB.
|
Control Group
n=29 Participants
A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects were patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
28.5 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
29 years
STANDARD_DEVIATION 5.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Central America
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
Africa
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.
Outcome measures
| Measure |
MI Varnish Group
n=26 Participants
33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.
|
Control Group
n=29 Participants
A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group.
Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group.
|
|---|---|---|
|
Enamel Decalcification Index (EDI) Scores
Total EDI score of 2-month visit
|
1.308 scores on a scale
Interval 0.138 to 2.477
|
2.724 scores on a scale
Interval 0.769 to 4.679
|
|
Enamel Decalcification Index (EDI) Scores
Total EDI score of 3-month visit
|
1.923 scores on a scale
Interval 0.382 to 3.464
|
3.966 scores on a scale
Interval 1.662 to 6.269
|
|
Enamel Decalcification Index (EDI) Scores
Total EDI score of 4-month visit
|
2.692 scores on a scale
Interval 0.778 to 4.607
|
5.897 scores on a scale
Interval 3.028 to 8.765
|
|
Enamel Decalcification Index (EDI) Scores
Total EDI score of 1-month visit
|
1.038 scores on a scale
Interval 0.268 to 1.809
|
1 scores on a scale
Interval 0.382 to 1.618
|
Adverse Events
MI Varnish Group
Control Group
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
Restriction type: LTE60