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

NCT03722264 | Completed Results FDA Device

• 1 other identifier: HM20011025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cavities of Teeth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Surface Topography and Hardness

  Time from initial bonding to extraction (max 90 days)

• Retention of OpalSeal

  Time from initial bonding to extraction (max 90 days)

Study Arms (2)

OpalSeal

EXPERIMENTAL

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

Device: OpalSeal

Transbond XT

PLACEBO COMPARATOR

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.

Device: TransbondXT

Interventions

OpalSeal DEVICE

OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets

OpalSeal

TransbondXT DEVICE

Transbond is a primer used to bond orthodontic brackets that does not contain fluoride

Transbond XT

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

School of Dentistry, Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Eser Tufekci, DDS, PhD
• Organization: Virginia Commonwealth University

etufekci@vcu.edu

804-828-9326

Study Officials

• Parthasarathy Madurantakam, DDS

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: November 16, 2017
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: March 4, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Locations

US (1)