Trial Outcomes & Findings for An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients (NCT NCT03722264)
NCT ID: NCT03722264
Last Updated: 2020-03-04
Results Overview
Teeth will be subjected to microCT to assess the extent of demineralization. Loss of mineral density will be measured as depth of lesions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Time from initial bonding to extraction (max 90 days)
Results posted on
2020-03-04
Participant Flow
12 participants were enrolled with all participants receiving each treatment
Participant milestones
| Measure |
Bilateral Treatment With OpalSeal and Transbond XT
Experimental: OpalSeal OpalSeal will be applied
to the buccal surfaces of to-be-extracted teeth on one side of the mouth which will be determined randomly for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm.
Placebo Comparator: Transbond XT TransbondXT will be applied
to the buccal surfaces of to-be-extracted teeth on the other side of the mouth which will be determined based on which side received OpalSeal for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Bilateral Treatment With OpalSeal and Transbond XT
Experimental: OpalSeal OpalSeal will be applied
to the buccal surfaces of to-be-extracted teeth on one side of the mouth which will be determined randomly for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm.
Placebo Comparator: Transbond XT TransbondXT will be applied
to the buccal surfaces of to-be-extracted teeth on the other side of the mouth which will be determined based on which side received OpalSeal for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo.
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|---|---|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bilateral Treatment With OpalSeal and Transbond XT
n=9 Participants
Experimental: OpalSeal OpalSeal will be applied
to the buccal surfaces of to-be-extracted teeth on one side of the mouth which will be determined randomly for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm.
Placebo Comparator: Transbond XT TransbondXT will be applied
to the buccal surfaces of to-be-extracted teeth on the other side of the mouth which will be determined based on which side received OpalSeal for each participant during bonding of orthodontic brackets, or to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo.
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|---|---|
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Age, Customized
|
NA Participants
n=9 Participants
|
|
Sex/Gender, Customized
Sex not measured
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9 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Time from initial bonding to extraction (max 90 days)Population: 9 teeth in each group were available for analysis
Teeth will be subjected to microCT to assess the extent of demineralization. Loss of mineral density will be measured as depth of lesions
Outcome measures
| Measure |
OpalSeal
n=9 teeth
OpalSeal will be applied
1. to the buccal surfaces of to-be-extracted teeth during bonding of orthodontic brackets, or
2. to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm,
OpalSeal: OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets
|
Transbond XT
n=9 teeth
TransbondXT will be applied
1. to the buccal surfaces of to-be-extracted teeth during bonding of orthodontic brackets, or
2. to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo.
TransbondXT: Transbond is a primer used to bond orthodontic brackets that does not contain fluoride
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|---|---|---|
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Loss of Mineral Density in the Enamel
|
70.8 microns
Interval 0.0 to 130.5
|
77.4 microns
Interval 0.0 to 245.3
|
SECONDARY outcome
Timeframe: Time from initial bonding to extraction (max 90 days)Population: Data could not be collected for this variable.
Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from initial bonding to extraction (max 90 days)Population: TransbondXT retention cannot be assessed so no control teeth were analyzed. Only 5 teeth on which OpalSeal was applied were analyzed
The protective effects of OpalSeal is subject to its retention at the site of application. Since OpalSeal fluoresces under black light, its retention will be evaluated
Outcome measures
| Measure |
OpalSeal
n=5 Participants
OpalSeal will be applied
1. to the buccal surfaces of to-be-extracted teeth during bonding of orthodontic brackets, or
2. to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm,
OpalSeal: OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets
|
Transbond XT
TransbondXT will be applied
1. to the buccal surfaces of to-be-extracted teeth during bonding of orthodontic brackets, or
2. to the proximal surfaces following IPR in accordance to manufacturer instructions. Transbond XT does not have fluoride and hence would be considered as a placebo.
TransbondXT: Transbond is a primer used to bond orthodontic brackets that does not contain fluoride
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|---|---|---|
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Retention of OpalSeal
|
28.1 percent coverage
Interval 0.0 to 37.5
|
—
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Adverse Events
OpalSeal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transbond XT
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
Eser Tufekci, DDS, PhD
Virginia Commonwealth University
Phone: 804-828-9326
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place