Trials / Completed
CompletedNCT03722264
An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients
An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Virginia Commonwealth University · Academic / Other
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
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?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OpalSeal | OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets |
| DEVICE | TransbondXT | Transbond is a primer used to bond orthodontic brackets that does not contain fluoride |
Timeline
- Start date
- 2017-11-16
- Primary completion
- 2019-04-12
- Completion
- 2019-04-12
- First posted
- 2018-10-26
- Last updated
- 2020-03-04
- Results posted
- 2020-02-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03722264. Inclusion in this directory is not an endorsement.