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Fluoride is very effective in preventing dental decay (cavities) when applied in the form of a varnish on tooth surfaces. The purpose of this study is to verify if fluoride-releasing primer (OpalSeal) offers more protection against early dental decay (cavity) compared to conventional primer (Transbond XT) during treatment with braces.
Primers are a type of 'glue' routinely used in orthodontics to attach brackets (metallic components) to the teeth. OpalSeal is a fluoride-releasing primer that has the potential to reduce cavities in patients receiving braces.
Orthodontic patients are at particular risk of developing two types of early carious lesions (decay):
Our research questions are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OpalSeal | Experimental | OpalSeal will be applied
|
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| Transbond XT | Placebo Comparator | TransbondXT will be applied
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OpalSeal | Device | OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loss of Mineral Density in the Enamel | Teeth will be subjected to microCT to assess the extent of demineralization. Loss of mineral density will be measured as depth of lesions | Time from initial bonding to extraction (max 90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Surface Topography and Hardness | Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal | Time from initial bonding to extraction (max 90 days) |
| Retention of OpalSeal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parthasarathy Madurantakam, DDS | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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12 participants were enrolled with all participants receiving each treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Although age was used to determine inclusion/exclusion into the study, data on age was not stored after enrollment.
Gender, and race/ethnicity data was not collected as they are not relevant variables for the outcomes studied
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Loss of Mineral Density in the Enamel | Teeth will be subjected to microCT to assess the extent of demineralization. Loss of mineral density will be measured as depth of lesions | 9 teeth in each group were available for analysis | Posted | Mean | Full Range | microns | Time from initial bonding to extraction (max 90 days) | teeth | teeth |
|
The study looked at participant teeth in an orthodontic setting. No medical data, including untoward or unfavorable medical occurrences, about the participants was available or collected for the study.
The study looked at participant teeth in an orthodontic setting. No medical data, including untoward or unfavorable medical occurrences, about the participants was available or collected for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OpalSeal | OpalSeal will be applied
OpalSeal: OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eser Tufekci, DDS, PhD | Virginia Commonwealth University | 804-828-9326 | etufekci@vcu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2017 | Feb 7, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Participants have at least two teeth planned for extraction on either side of the mouth. The study will use a split-mouth design with random assignments for intervention (OpalSeal) on one tooth.
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Opalseal and TransbondXT are identical in color, consistency and application allowing random assignments as well as patient blinding.
The outcomes assessor will also be blinded to the groups assignments.
| TransbondXT | Device | Transbond is a primer used to bond orthodontic brackets that does not contain fluoride |
|
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
| Time from initial bonding to extraction (max 90 days) |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Transbond XT |
TransbondXT will be applied
TransbondXT: Transbond is a primer used to bond orthodontic brackets that does not contain fluoride |
|
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| Secondary | Surface Topography and Hardness | Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal | Data could not be collected for this variable. | Posted | Time from initial bonding to extraction (max 90 days) |
|
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| Secondary | Retention of OpalSeal | 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 | TransbondXT retention cannot be assessed so no control teeth were analyzed. Only 5 teeth on which OpalSeal was applied were analyzed | Posted | Median | Full Range | percent coverage | Time from initial bonding to extraction (max 90 days) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Transbond XT | TransbondXT will be applied
TransbondXT: Transbond is a primer used to bond orthodontic brackets that does not contain fluoride | 0 | 0 | 0 | 0 | 0 | 0 |
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