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Trial record 35 of 1201 for:    tooth decay

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

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ClinicalTrials.gov Identifier: NCT03722264
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cavities of Teeth Device: OpalSeal Device: TransbondXT Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: OpalSeal

OpalSeal will be applied

  1. to the buccal surfaces of to-be-extracted teeth 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
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

  1. to the buccal surfaces of to-be-extracted teeth 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
Transbond is a primer used to bond orthodontic brackets that does not contain fluoride




Primary Outcome Measures :
  1. Loss of mineral density in the enamel [ Time Frame: Time from initial bonding to extraction (max 90 days) ]
    Teeth will be subjected to microCT to assess the extent of demineralization


Secondary Outcome Measures :
  1. Surface topography and hardness [ Time Frame: 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

  2. Retention of OpalSeal [ Time Frame: 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



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722264


Locations
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United States, Virginia
School of Dentistry, Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Parthasarathy Madurantakam, DDS,MDS,PhD    804-828-4953    madurantakap@vcu.edu   
Contact: Eser Tufekci, DDS,MS,PhD    804 828 9326    etufekci@vcu.edu   
Sub-Investigator: Caroline Carrico, PhD         
Sub-Investigator: Alyssa Ricci, DDS         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Parthasarathy Madurantakam, DDS Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03722264     History of Changes
Other Study ID Numbers: HM20011025
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs