White Spot LesionNCT04560478
Comparing Fluoride Varnish and Sealant to Prevent White Spots in Orthodontic Patients
A study testing Pro Seal Sealant and MI Varnish in people with White Spot Lesion, run by Texas A&M University at 1 site in United States.
Trial summary
The purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion (WSL) formation in orthodontic patients. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Pro Seal Sealant and MI Varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Mar 2020
- Phase
- Interventional
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no significant medical history
- no underlying medical problems such as Sjogren's Syndrome or conditions requiring more than 2 medications (to prevent bias of possible dry mouth)
- less than 17 years old at the start of orthodontic treatment,
- fully erupted permanent maxillary canines and incisors, starting fixed orthodontic treatment
- ability to come to appointments every 4-6 weeks.
Who cannot join
- professional fluoride application in the last 3 months
- allergy to milk
- untreated cavitated lesions
- heavy initial fluorosis
- dry mouth
- pregnancy
- any illness/condition that the investigators felt would affect the study outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University College of Dentistry
Dallas, Texas, 75246
About this study
Official title: THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS: A RANDOMIZED CLINICAL TRIAL
The purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion (WSL) formation in orthodontic patients.
Read the detailed description
This prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups. Group 1 (Sealant Group) received sealant on the maxillary anterior canines, lateral incisors, and central incisors, with reapplication of the sealant every 3 months. Group 2 (Varnish Group) had MI Varnish applied every 4-6 weeks, without sealant placed on the maxillary anterior teeth. White spot lesion formation was evaluated with standardized digital photographs at two timepoints, T1 (initial appointment before bonding), and T2 (12 months later, with brackets removed). The brackets were removed in order to facilitate an adequate photographic exam. Photographs were analyzed side-by-side at the conclusion of the study with the Enamel Decalcification Index (EDI). The location of WSLs were recorded by tooth type and by region. Oral hygiene was evaluated at T1 and T2.
- Conditions
- White Spot Lesion
- Being tested
- Pro Seal Sealant, MI Varnish
- Keywords
- Oral Hygiene, Orthodontics, White spot lesion, enamel decalcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro Seal SealantDevice
Sealant was reapplied every 3 months
MI VarnishDevice
Fluoride varnish was applied every 4-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pro Seal Sealant | Active comparator | ProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine) Receives: Device: Pro Seal Sealant |
| MI Varnish | Active comparator | MI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine) Receives: Device: MI Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel Decalcification Index
Extent and severity of white spot lesion formation
Measured: 12 months
Secondary outcomes (4)
Location of White Spot Lesions
Mesial, Distal, Incisal or Gingival Region
Measured: 12 months
Most Common Tooth for White Spot Formation
Maxillary Canine, Lateral, or Central Incisor
Measured: 12 Months
Oral Hygiene Status
Measurement of plaque accumulation on maxillary teeth
Measured: 12 Months
Sex Differences
Male versus Female
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Oct 2018
- Primary completion10 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- single center, parallel, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Buschang, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560478
- Sponsor's protocol ID
- COD_Ortho2
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual results of the study will not be shared.
Publications
Banks PA, Richmond S. Enamel sealants: a clinical evaluation of their value during fixed appliance therapy. Eur J Orthod. 1994 Feb;16(1):19-25. doi: 10.1093/ejo/16.1.19.
PubMed 8181546Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
PubMed 5264376
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT04560478
- Acronym / sponsor ID
- COD_Ortho2
- Conditions
- White Spot Lesion
- Keywords
- Oral Hygiene, Orthodontics, White spot lesion, enamel decalcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 23 Sep 2020 (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.
The purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion (WSL) formation in orthodontic patients.
Detailed description
This prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups. Group 1 (Sealant Group) received sealant on the maxillary anterior canines, lateral incisors, and central incisors, with reapplication of the sealant every 3 months. Group 2 (Varnish Group) had MI Varnish applied every 4-6 weeks, without sealant placed on the maxillary anterior teeth. White spot lesion formation was evaluated with standardized digital photographs at two timepoints, T1 (initial appointment before bonding), and T2 (12 months later, with brackets removed). The brackets were removed in order to facilitate an adequate photographic exam. Photographs were analyzed side-by-side at the conclusion of the study with the Enamel Decalcification Index (EDI). The location of WSLs were recorded by tooth type and by region. Oral hygiene was evaluated at T1 and T2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single center, parallel, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Pro Seal Sealant | Active comparator | Device: Pro Seal SealantProSeal Sealant was applied to the facial surfaces of the maxillary anterior teeth (canine to canine) |
| MI Varnish | Active comparator | Device: MI VarnishMI Fluoride Varnish was applied to the maxillary anterior teeth (canine to canine) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- no significant medical history
- no underlying medical problems such as Sjogren's Syndrome or conditions requiring more than 2 medications (to prevent bias of possible dry mouth)
- less than 17 years old at the start of orthodontic treatment,
- fully erupted permanent maxillary canines and incisors, starting fixed orthodontic treatment
- ability to come to appointments every 4-6 weeks.
Key exclusion criteria (7 listed)
- professional fluoride application in the last 3 months
- allergy to milk
- untreated cavitated lesions
- heavy initial fluorosis
- dry mouth
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 |
|---|---|---|
| Pro Seal SealantSealant was reapplied every 3 months | Device | Pro Seal Sealant |
| MI VarnishFluoride varnish was applied every 4-6 weeks | Device | MI Varnish |
Primary outcome
Enamel Decalcification Index
Time frame: 12 months
Extent and severity of white spot lesion formation
4 secondary outcomes
Location of White Spot Lesions
Time frame: 12 months
Most Common Tooth for White Spot Formation
Time frame: 12 Months
Oral Hygiene Status
Time frame: 12 Months
Sex Differences
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Results publication: PubMed 8181546Banks PA, Richmond S. Enamel sealants: a clinical evaluation of their value during fixed appliance therapy. Eur J Orthod. 1994 Feb;16(1):19-25. doi: 10.1093/ejo/16.1.19.
- Results publication: PubMed 5264376Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
- Individual participant dataSharing planned: No. Individual results of the study will not be shared.
Related trials for White Spot Lesion
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A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
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Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
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EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
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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.
Peter Buschang, PhD principal investigator
Texas A&M 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 Pro Seal Sealant and MI Varnish in people with White Spot Lesion, run by Texas A&M 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 5 inclusion and 7 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 23 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Enamel Decalcification Index (time frame: 12 months). 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 NCT04560478, which also lists 2 linked publications.
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 23 Sep 2020.