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

Cavities of Teeth Clinical Trial

Official title:

An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722264
• Other study ID #: HM20011025
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: April 12, 2019

Study information

• Verified date: February 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cavities of Teeth
• Dental Caries

Intervention

Device:
• OpalSeal
OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets
• TransbondXT
Transbond is a primer used to bond orthodontic brackets that does not contain fluoride

Locations

Country	Name	City	State
United States	School of Dentistry, Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 from initial bonding to extraction (max 90 days)
Secondary	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)
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 from initial bonding to extraction (max 90 days)