An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients
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|ClinicalTrials.gov Identifier: NCT03722264|
Recruitment Status : Completed
First Posted : October 26, 2018
Results First Posted : February 10, 2020
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cavities of Teeth||Device: OpalSeal Device: TransbondXT||Not Applicable|
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):
- Around the brackets called White Spot Lesions and
- Along the sides of the teeth after slenderization procedure called inter-proximal reduction (IPR).
Our research questions are:
- Can OpalSeal offer protection against white spot lesions (WSL) around the brackets?
- Can OpalSeal offer protection against decay on the sides of teeth following IPR?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||Double (Participant, Outcomes Assessor)|
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.
|Official Title:||An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study|
|Actual Study Start Date :||November 16, 2017|
|Actual Primary Completion Date :||April 12, 2019|
|Actual Study Completion Date :||April 12, 2019|
OpalSeal will be applied
OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets
Placebo Comparator: Transbond XT
TransbondXT will be applied
Transbond is a primer used to bond orthodontic brackets that does not contain fluoride
- Loss of Mineral Density in the Enamel [ Time Frame: 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
- Surface Topography and Hardness [ Time Frame: 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 Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722264
|United States, Virginia|
|School of Dentistry, Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Parthasarathy Madurantakam, DDS||Virginia Commonwealth University|