White Spot LesionPhase 4NCT03711097
Effectiveness of Resin-Modified Glass Ionomer Varnish in Preventing White Spot Lesions in Fixed Appliance Orthodontia
A Phase 4 study testing Vanish XT Dental Varnish in people with White Spot Lesion, run by University of Nebraska.
Trial summary
This is a prospective study to determine the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a preventative material placed on teeth. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Vanish XT Dental Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2019to 22 Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willingness to participate in research project
- Age ≥ 10 years old, fully erupted maxillary central and lateral incisors
- treatment time with fixed appliances estimated to be at least 6 months
Who cannot join
- Presence of peg lateral maxillary incisors
- Presence of one or more significant WSLs on maxillary incisors prior to orthodontic therapy
- Restorations covering a significant portion of the labial surfaces of the maxillary incisors
- Unerupted maxillary incisors, presence of uncontrolled caries
- Craniofacial Syndromic patients and patients with cleft lip and/or palate
- Pregnant or breast-feeding patients
About this study
Official title: The Effectiveness of Resin-Modified Glass Ionomer Varnish in Preventing White Spot Lesions During Fixed Appliance Orthodontic Therapy
This is a prospective study to determine the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a preventative material placed on teeth. The RMGI will be applied at the initial bonding appointment when braces are put on. RMGI will be applied to some participant's teeth while others will not receive the varnish treatment. Patients will be given standardized oral hygiene instructions. At six months, the RMGI will be reapplied to the same teeth that received the original RMGI application. The development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Participants will be examined at 3-month intervals for a total of nine months to one year to determine if application of RMGI during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.
Read the detailed description
This study is a prospective study to assess the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a material that is placed on the teeth to prevent WSLs. Patients will be recruited from the UNMC College of Dentistry Orthodontic Clinic who have been treatment planned to undergo fixed appliance therapy to include the maxillary central and lateral and central incisor teeth, which are the upper front four teeth in the mouth. In order to be included in this study, these teeth need to be fully erupted and planned to have braces on their front surfaces for a minimum of six months. The RMGI will be applied at the initial bonding appointment, which is the appointment that the subject receives their braces, to the labial surfaces of the teeth either to the right or left side central and lateral incisor. The control teeth will be the upper central and lateral incisors that do not receive the varnish treatment. Assignment of the left or right side will be randomized to obtain equal numbers of left and right-sided RMGI applications, mitigating the potential effects related to the handedness of the patients. The patients will be given standardized oral hygiene instructions and will be seen in follow up at 3-month intervals. At the 6-month mark, the RMGI will be reapplied to the same teeth that received the original RMGI application. At the initial bonding appointment and at each 3-month interval following, the development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Measurements and application of the RMGI will be performed by an individual examiner and a random subset of measurements will be re-measured after adequate washout time to ensure high intra-examiner reliability. Photographs will be assessed by examiners that have been blinded to the teeth receiving treatment. The goal of this study is to have the patients examined at 3-month intervals for a total treatment time of nine months to one year to ascertain if application of RMGI to the labial surfaces of the central and lateral incisor teeth during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.
- Conditions
- White Spot Lesion
- Being tested
- Vanish XT Dental Varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanish XT Dental VarnishDrug
Also called resin-modified glass ionomer
Varnish will be applied to the front surface of the intervention upper central and lateral incisors
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Upper left or right central and lateral incisor |
| Varnish Intervention | Experimental | Upper central and lateral incisor contralateral to control upper central and lateral incisor Receives: Drug: Vanish XT Dental Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of White Spot Lesion on the Labial Surface of the Upper Central and/or Lateral Incisors
The development of white spot lesion in subjects will be determined by photographs that are evaluated for white spot lesions by experienced orthodontists as well as by objectively measuring the level of demineralization of the teeth based on dental scanning technology (The Canary System). The Canary System gives a numerical score based on the level of demineralization of the tooth and indicates if demineralization is progressing or improving over time.
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start22 Apr 2019
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Why it stopped: Study not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Brad Herman, DDS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711097
- Sponsor's protocol ID
- 0548-18-FB
- Status last verified
- Aug 2024
- First submitted
- 14 Oct 2018
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Resin-Modified Glass Ionomer Varnish in Preventing White Spot Lesions During Fixed Appliance Orthodontic Therapy
- ClinicalTrials.gov ID
- NCT03711097
- Acronym / sponsor ID
- 0548-18-FB
- Conditions
- White Spot Lesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study to determine the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a preventative material placed on teeth. The RMGI will be applied at the initial bonding appointment when braces are put on. RMGI will be applied to some participant's teeth while others will not receive the varnish treatment. Patients will be given standardized oral hygiene instructions. At six months, the RMGI will be reapplied to the same teeth that received the original RMGI application. The development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Participants will be examined at 3-month intervals for a total of nine months to one year to determine if application of RMGI during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.
Detailed description
This study is a prospective study to assess the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a material that is placed on the teeth to prevent WSLs. Patients will be recruited from the UNMC College of Dentistry Orthodontic Clinic who have been treatment planned to undergo fixed appliance therapy to include the maxillary central and lateral and central incisor teeth, which are the upper front four teeth in the mouth. In order to be included in this study, these teeth need to be fully erupted and planned to have braces on their front surfaces for a minimum of six months. The RMGI will be applied at the initial bonding appointment, which is the appointment that the subject receives their braces, to the labial surfaces of the teeth either to the right or left side central and lateral incisor. The control teeth will be the upper central and lateral incisors that do not receive the varnish treatment. Assignment of the left or right side will be randomized to obtain equal numbers of left and right-sided RMGI applications, mitigating the potential effects related to the handedness of the patients. The patients will be given standardized oral hygiene instructions and will be seen in follow up at 3-month intervals. At the 6-month mark, the RMGI will be reapplied to the same teeth that received the original RMGI application. At the initial bonding appointment and at each 3-month interval following, the development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Measurements and application of the RMGI will be performed by an individual examiner and a random subset of measurements will be re-measured after adequate washout time to ensure high intra-examiner reliability. Photographs will be assessed by examiners that have been blinded to the teeth receiving treatment. The goal of this study is to have the patients examined at 3-month intervals for a total treatment time of nine months to one year to ascertain if application of RMGI to the labial surfaces of the central and lateral incisor teeth during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Upper left or right central and lateral incisor |
| Varnish Intervention | Experimental | Drug: Vanish XT Dental VarnishUpper central and lateral incisor contralateral to control upper central and lateral incisor |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to participate in research project
- Age ≥ 10 years old, fully erupted maxillary central and lateral incisors
- treatment time with fixed appliances estimated to be at least 6 months
Key exclusion criteria (6 listed)
- Presence of peg lateral maxillary incisors
- Presence of one or more significant WSLs on maxillary incisors prior to orthodontic therapy
- Restorations covering a significant portion of the labial surfaces of the maxillary incisors
- Unerupted maxillary incisors, presence of uncontrolled caries
- Craniofacial Syndromic patients and patients with cleft lip and/or palate
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 |
|---|---|---|
| Vanish XT Dental VarnishAlso: resin-modified glass ionomerVarnish will be applied to the front surface of the intervention upper central and lateral incisors | Drug | Varnish Intervention |
Primary outcome
Development of White Spot Lesion on the Labial Surface of the Upper Central and/or Lateral Incisors
Time frame: 6-9 months
The development of white spot lesion in subjects will be determined by photographs that are evaluated for white spot lesions by experienced orthodontists as well as by objectively measuring the level of demineralization of the teeth based on dental scanning technology (The Canary System). The Canary System gives a numerical score based on the level of demineralization of the tooth and indicates if demineralization is progressing or improving over time.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for White Spot Lesion
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
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Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
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Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
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.
Brad Herman, DDS principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vanish XT Dental Varnish in people with White Spot Lesion, run by University of Nebraska.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Development of White Spot Lesion on the Labial Surface of the Upper Central and/or Lateral Incisors (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2024.