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

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.

Study Overview

• Status: Completed
• Conditions: Cavities of Teeth
• Intervention / Treatment: Device: OpalSeal; Device: TransbondXT

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?

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • School of Dentistry, Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OpalSeal; OpalSeal will be applied; 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; to the proximal surfaces following IPR in accordance to manufacturer instructions. Since OpalSeal has fluoride releasing capability, this would be experimental arm	Device: OpalSeal; 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; 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; 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.	Device: TransbondXT; Transbond is a primer used to bond orthodontic brackets that does not contain fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Parthasarathy Madurantakam, DDS, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): April 12, 2019
• Study Completion (Actual): April 12, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: HM20011025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No