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

Not Applicable

Completed

• Conditions: Cavities of Teeth
• Interventions: Device: OpalSeal; Device: TransbondXT

• Registration Number: NCT03722264
• Lead Sponsor: Virginia Commonwealth University

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?

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-16
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-26
• Primary Completion: 2019-04-12
• Study Completion: 2019-04-12
• Results First Submitted: 2020-01-17
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-24
• Results First Posted: 2020-02-25
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OpalSeal	OpalSeal	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
Transbond XT	TransbondXT	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

School of Dentistry, Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States