An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Cavities of Teeth

Treatments: Device: OpalSeal; Device: TransbondXT

Study type: Interventional

Funder types: Other

Identifiers

NCT03722264

HM20011025

Details and patient eligibility

About

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.

Full 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?

Enrollment: 12 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

OpalSeal

Experimental group

Description:

OpalSeal will be applied 1. 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 2. to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm

Treatment:

Device: OpalSeal

Transbond XT

Placebo Comparator group

Description:

TransbondXT will be applied 1. 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 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.

Treatment:

Device: TransbondXT