Cavities of Teeth
Conditions
Brief summary
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.
Detailed description
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): 1. Around the brackets called White Spot Lesions and 2. Along the sides of the teeth after slenderization procedure called inter-proximal reduction (IPR). Our research questions are: 1. Can OpalSeal offer protection against white spot lesions (WSL) around the brackets? 2. Can OpalSeal offer protection against decay on the sides of teeth following IPR?
Interventions
DEVICEOpalSeal
OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets
DEVICETransbondXT
Transbond is a primer used to bond orthodontic brackets that does not contain fluoride
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age 10 and older seeking treatment at the VCU Orthodontics Clinic who require extraction of at least 2 teeth for orthodontic purposes * Such teeth should be free of any developmental defects
Exclusion criteria
* Patients under 10 years of age * Patients with defective teeth * Those who cannot provide consent/assent OR not able to follow research protocols * Protected population (prisoners)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss of Mineral Density in the Enamel | Time from initial bonding to extraction (max 90 days) | Teeth will be subjected to microCT to assess the extent of demineralization. Loss of mineral density will be measured as depth of lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surface Topography and Hardness | Time from initial bonding to extraction (max 90 days) | Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal |
| Retention of OpalSeal | Time from initial bonding to extraction (max 90 days) | 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 |
Countries
United States
Participant flow
Recruitment details
12 participants were enrolled with all participants receiving each treatment
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Bilateral Treatment With OpalSeal and Transbond XT | — |
|---|---|---|
| Age, Customized | NA Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 9 participants | — |
| Sex/Gender, Customized Sex not measured | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: Time from initial bonding to extraction (max 90 days)
Population: 9 teeth in each group were available for analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OpalSeal | Loss of Mineral Density in the Enamel | 70.8 microns |
| Transbond XT | Loss of Mineral Density in the Enamel | 77.4 microns |
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
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OpalSeal | Retention of OpalSeal | 28.1 percent coverage |
Secondary
Surface Topography and Hardness
Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal
Time frame: Time from initial bonding to extraction (max 90 days)
Population: Data could not be collected for this variable.