Cavities of TeethNCT03722264

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

A study testing OpalSeal and TransbondXT in people with Cavities of Teeth, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Cavities of Teeth
What is being tested?: OpalSeal and TransbondXT
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 16 Nov 2017to 12 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

School of Dentistry, Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

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

Read the 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):

Around the brackets called White Spot Lesions and
Along the sides of the teeth after slenderization procedure called inter-proximal reduction (IPR).

Our research questions are:

Can OpalSeal offer protection against white spot lesions (WSL) around the brackets?
Can OpalSeal offer protection against decay on the sides of teeth following IPR?

Conditions: Cavities of Teeth
Being tested: OpalSeal, TransbondXT
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OpalSealDevice
OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets
TransbondXTDevice
Transbond is a primer used to bond orthodontic brackets that does not contain fluoride

Study groups in NCT03722264
Study group	Role	What they receive
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 Receives: 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. Receives: Device: TransbondXT

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Time from initial bonding to extraction (max 90 days)

Secondary outcomes (2)

Surface Topography and Hardness
Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal
Measured: 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
Measured: Time from initial bonding to extraction (max 90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 201712 Apr 2019

First posted26 Oct 2018
Study start16 Nov 2017
Primary completion12 Apr 2019
Study completion12 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cavities of TeethStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03722264
Sponsor's protocol ID: HM20011025
Status last verified: Feb 2020
First submitted: 25 Oct 2018
Last updated: 4 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cavities of Teeth trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study
ClinicalTrials.gov ID: NCT03722264
Acronym / sponsor ID: HM20011025
Conditions: Cavities of Teeth
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Study start: 16 Nov 2017 (actual)
Primary completion: 12 Apr 2019 (actual)
Study completion: 12 Apr 2019 (actual)
First posted: 26 Oct 2018 (actual)
Results: Posted 25 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Orthodontic patients are at particular risk of developing two types of early carious lesions (decay):

Around the brackets called White Spot Lesions and
Along the sides of the teeth after slenderization procedure called inter-proximal reduction (IPR).

Our research questions are:

Can OpalSeal offer protection against white spot lesions (WSL) around the brackets?
Can OpalSeal offer protection against decay on the sides of teeth following IPR?

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
OpalSeal	Experimental	Device: OpalSealOpalSeal 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	Placebo comparator	Device: TransbondXTTransbondXT 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.

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OpalSealOpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets	Device	OpalSeal
TransbondXTTransbond is a primer used to bond orthodontic brackets that does not contain fluoride	Device	Transbond XT

Primary outcome

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. Loss of mineral density will be measured as depth of lesions

2 secondary outcomes

Surface Topography and Hardness
Time frame: Time from initial bonding to extraction (max 90 days)
Retention of OpalSeal
Time frame: Time from initial bonding to extraction (max 90 days)

Results and safety

Results posted to the registry on 25 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bilateral Treatment With OpalSeal and Transbond XT	12	9

Primary outcome: Loss of Mineral Density in the Enamel

Time frame: Time from initial bonding to extraction (max 90 days). Mean (Full Range). Unit: microns

Measure	OpalSeal n = 9	Transbond XT n = 9
Value	70.8 (0 to 130.5)	77.4 (0 to 245.3)

Population analysed: 9 teeth in each group were available for analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study looked at participant teeth in an orthodontic setting. No medical data, including untoward or unfavorable medical occurrences, about the participants was available or collected for the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OpalSeal	0 of 0	0 of 0	0
Transbond XT	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Parthasarathy Madurantakam, DDS principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OpalSeal and TransbondXT in people with Cavities of Teeth, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loss of Mineral Density in the Enamel (time frame: Time from initial bonding to extraction (max 90 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03722264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.