Dental CariesNCT04528134
Orthodontic Varnish Microbiology Study
A study testing Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish and 5% Sodium Fluoride Varnish in people with Dental Caries and Dental Plaque, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Orthodontic treatment is common in teenagers, which typically involve the attachment of metal brackets to the teeth. These brackets often impede proper oral hygiene, leading to plaque accumulation and the development of white spots lesions (the early stage of cavity development). Read more about this study
- Who is it for?
- Ages 12 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Plaque, Dental White Spot
- What is being tested?
- Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish and 5% Sodium Fluoride Varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 1 Jul 2025
- 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 12 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males and females, 12-17 years of age, inclusive, at the time the Assent and Informed Consent Form is signed
- Systemically healthy, as determined by the investigator (in consultation with the Medical Monitor, as needed), based on medical history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during screening
- Is approaching the end of their orthodontic treatment using metal fixed oral appliances (brackets) on at least the maxillary arch
- Subject has at least two visible white spot lesions at the time of recruitment on teeth treated with fixed oral appliances
- Subject is willing to use only oral care products that fall within the standard of care (manual toothbrush and sodium fluoride toothpaste) for the duration of the study.
- Subject is willing to postpone dental cleanings between the baseline and final visit (since subjects will receive cleanings 6 months apart at both the baseline and final visit, the standard of care will be maintained).
Show all 9Show fewer
- Subject is willing and able to comply with oral hygiene and diet instructions.
- Subject is able to understand and sign the Assent and/or Informed Consent Form prior to initiation of study procedures
- Subject is able to communicate with the Investigator/study personnel, understand and comply with the study requirements, and is willing to return for protocol-specified visits at the appointed times.
Who cannot join
- Advanced periodontal disease
- Medical condition (e.g. artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
- Pathologic lesions of the oral cavity (suspected or confirmed)
- Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the investigators could influence the study outcome, within 30 days prior to screening.
- Presence of any condition or concurrent illness, which in the opinion of the investigators, would compromise normal immune function ((e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results
- Presence of xerostomia (dry mouth).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Dentistry
Los Angeles, California, 90095
About this study
Official title: The Effect of Light-cured Fluoride Varnish to Remineralize Post-orthodontic White Spot Lesions and Change the Oral Microbiome: a Double-blind, Split-mouth Randomized Clinical Trial
Orthodontic treatment is common in teenagers, which typically involve the attachment of metal brackets to the teeth. These brackets often impede proper oral hygiene, leading to plaque accumulation and the development of white spots lesions (the early stage of cavity development). Our study aims to investigate the efficacy of different commercially available fluoride varnishes to treat these white spot lesions after the completion of orthodontic treatment and evaluate their effect on the oral microbiome.
Target enrollment is 120 subjects. The study will follow a split-mouth design, with each subject receiving different treatment on the left and right sides of their mouth. The subjects will be randomized into 3 groups, with each group receiving two of the following three options: placebo varnish, traditional sodium fluoride varnish, and a resin-modified glass ionomer light-cured fluoride varnish. There will be 4 total visits for this study:
Read more
Baseline (day 0): Oral health assessed, plaque collected, intraoral photos taken, dental cleaning performed, DiagnoDent measurements taken, varnishes applied T1 (day 30): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T2 (day 90): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T3 (day 180): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, dental cleaning performed
Participants will be instructed to use regular fluoridated toothpaste and floss twice per day for the duration of the study.
Read the detailed description
- Orthodontic patients ages 12-27 (target 120 subjects) nearing the end of treatment with metal braces at the UCLA Orthodontic Clinic will be recruited.
- Patients will be consented by the investigators or an eligible and trained orthodontic resident.
- Participants will be assigned into one of three groups via stratified permuted block randomization. The groups will receive treatment as follows in a split-mouth study design: Group 1 - extended contact varnish on upper left and lower right teeth, 5% fluoride varnish on upper right and lower left teeth Group 2 - placebo varnish on upper left and lower right teeth, extended contact varnish on upper right and lower left teeth Group 3 - 5% fluoride varnish on upper left and lower right teeth, placebo varnish on upper right and lower left teeth
- Shortly after a subject's braces are removed, each subject will fill out an oral health questionnaire and the investigators will use Trace Plaque Disclosing Liquid (a safe, commercially available product) to visualize the plaque. Intraoral photos of only the teeth surfaces will be taken. Dental plaque samples will be collected from buccal surfaces of the teeth. The plaque will be collected with a sterile dental instrument and carefully deposited into a sterile plastic collection tube containing a nutrient solution for the bacteria. After collection, the samples will be taken to the laboratory for further analysis and no subject identifiers will be used. The samples will be plated and total DNA from each will be extracted, and sequencing analysis will be performed in order to determine the relative abundance of each species in the samples.
- A professional cleaning will be done of the subjects teeth to remove all remaining plaque and calculus buildup on the teeth.
- After the cleaning, the subject will rinse with water and a second set of intraoral photos will be taken. The teeth will then be air dried for 15 seconds, and a third set of intraoral photos will be taken.
- The extent of the demineralized white spot lesions will be quantitatively assessed using the DiagnoDent, where a laser is shined on the teeth and the fluorescence is measured to assess the depth/severity of the demineralization.
- The study varnishes will be applied to the patient's teeth (according to the manufacturer's instructions), consistent with their group allocation.
- The patient will be given written post-op instructions, including oral hygiene instructions to use OTC sodium fluoride toothpaste and a manual toothbrush. The subjects will be asked to refrain from using adjunctive fluoride products (such as mouthwash) for the duration of the study. Since all subjects will receive another professional cleaning at their 6-month visit (consistent with the standard of care to receive professional cleanings every 6 months), they will be asked to not receive additional dental cleanings from outside providers.
- Subjects will return to the clinic after 30, 90, and 180 days. At each appointment, they will have their plaque disclosed with Trace Plaque Disclosing solution, have 3 sets of intraoral photos taken (with plaque, with clean/moist teeth, and with clean/dry teeth), have the white spot lesion severity measured with the DiagnoDent, and have the varnishes reapplied to their teeth (except at the last, where the varnish will not be reapplied).
- At the final visit (day 180), subjects will receive a professional dental cleaning after the photos have been assessed.
- After study completion, blinded investigators will use the intraoral photos to (1) assess the extent of plaque using various plaque indices, and (2) assess the severity of white spot lesions using various visual indices.
- Conditions
- Dental Caries, Dental Plaque, Dental White Spot
- Being tested
- Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish, 5% Sodium Fluoride Varnish
- Keywords
- Orthodontics
- Medical subject headings
- Dental Caries, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Contact RMGI (Resin-modified Glass Ionomer) VarnishDevice
Also called 3M™ Vanish™ XT Extended Contact Varnish
This is a light-cured, durable coating that forms an immediate layer of protection that releases fluoride, calcium and phosphate and can be recharged with fluoride by using fluoride-containing products over the 6-month life of the product.
5% Sodium Fluoride VarnishDevice
Also called Henry Schein Acclean 5% Sodium Fluoride Varnish
This is a 5% Sodium Fluoride varnish that hardens on the teeth upon contact with saliva.
| Study group | Role | What they receive |
|---|---|---|
| Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish | Experimental | This group will receive extended contact (XT) varnish on their upper left and lower right teeth, and traditional 5% sodium fluoride varnish on their upper right and lower left teeth. Receives: Device: Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish; Device: 5% Sodium Fluoride Varnish |
| Placebo Varnish/Extended Contact RMGI Varnish | Experimental | This group will receive placebo varnish on their upper left and lower right teeth, and extended contact (XT) varnish on their upper right and lower left teeth. Receives: Device: Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish |
| 5% Sodium Fluoride Varnish/Placebo Varnish | Active comparator | This group will receive traditional 5% sodium fluoride varnish on their upper left and lower right teeth, and placebo varnish on their upper right and lower left teeth. Receives: Device: 5% Sodium Fluoride Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Spot Lesion Severity
Assessed change in severity of white spots on the teeth as measured by the DiagnoDent, which uses quantitative light-induced fluorescence to assess the depth/severity of enamel demineralization. The DiagnoDent gives a score from 0-100, with 100 indicating the most demineralization (worse outcome) and 0 indicating the least demineralization (best outcome).
Measured: 6 months
Secondary outcomes (4)
Dental Plaque Levels
Assessed change in plaque levels, as measured by the Turesky-modified Quigley Hein Plaque Index. This index is measured on a scale of 0 to 5, with 5 representing the most plaque present (worst outcome) and 0 representing the least plaque present (best outcome). Below are the definitions of the scoring:
0: no plaque on the tooth
- flecks of plaque along the gum margin
- a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth
- a band of plaque wider than 1 mm covering less than one third of the crown of the tooth
- plaque covering at least one-third but less than two thirds of the crown of the tooth
- plaque covering two-thirds or more of the crown of the tooth
Measured: 6 months
Microbial Load
Colony forming units were measured on BHI (Brain Heart Infusion) plated samples from the different subject groups. BHI plating allows for culturing microorganisms in a nutrient-rich environment that serves as a versatile growth medium. A higher score indicates a higher presence of microorganisms (worse outcome), and a lower score indicates a lower presence of microorganisms (better outcome). There is no maximum score for CFUs, and a score of 0 would indicate a sterile sample where no microorganisms were detected.
Measured: 6 months
Plaque and Saliva Microbial Colonization of S. Mutans
Change in amounts of Streptococcus mutans, as measured by counting Colony-Forming Units (CFUs) after plating samples on a medium that is specifically targeted to cultivate Streptococcus microorganisms. A higher score indicates a higher presence of Streptococcus mutans (worse outcome), and a lower score indicates a lower presence of Streptococcus mutans (better outcome). There is no maximum score for CFUs, and a score of 0 would indicate a sample where no Streptococcus microorganisms were detected.
Measured: 6 months
White Spot Lesion Clinical Appearance
Assessed change in the visual appearance of white spots on the teeth, as measured by the ICDAS (International Caries Detection and Assessment System) from clinical photographs. The lowest score (0) indicates the best outcome, and the highest score (6) indicates the worst outcome.
0: Sound tooth surface, no evidence of decay
- First visual change in enamel
- Distinct visual change in enamel
- Localized enamel breakdown, small cavitation or breakdown of the enamel without visible dentin showing
- Underlying dark shadow from dentin, possible small breaks in enamel
- Distinct cavity exposing underlying dentin involving less than half the tooth
- Extensive distinct cavity exposing the dentin involving at least half of the tooth surface and potentially reaching the pulp
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start7 Feb 2022
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into one of 3 groups, each of which will receive two of the following three interventions: extended contact varnish, traditional fluoride varnish, placebo varnish. Subjects will receive the interventions in a split-mouth design, with one treatment on half of their teeth and another treatment on the other half of their teeth.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Brennan, University of California, Los Angeles
- Investigators
- Tyler Brennan, DDS, Principal investigator, University of California, Los AngelesRenate Lux, PhD, Study chair, University of California, Los AngelesNini Tran, DDS, PhD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528134
- Sponsor's protocol ID
- IRB#20-001077
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2020
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only de-identified and aggregate data will be made available to researchers outside the study team.
Publications
Klaus K, Eichenauer J, Sprenger R, Ruf S. Oral microbiota carriage in patients with multibracket appliance in relation to the quality of oral hygiene. Head Face Med. 2016 Oct 28;12(1):28. doi: 10.1186/s13005-016-0125-x.
PubMed 27793169Freitas AO, Marquezan M, Nojima Mda C, Alviano DS, Maia LC. The influence of orthodontic fixed appliances on the oral microbiota: a systematic review. Dental Press J Orthod. 2014 Mar-Apr;19(2):46-55. doi: 10.1590/2176-9451.19.2.046-055.oar.
PubMed 24945514Sundararaj D, Venkatachalapathy S, Tandon A, Pereira A. Critical evaluation of incidence and prevalence of white spot lesions during fixed orthodontic appliance treatment: A meta-analysis. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):433-9. doi: 10.4103/2231-0762.167719.
PubMed 26759794Tasios T, Papageorgiou SN, Papadopoulos MA, Tsapas A, Haidich AB. Prevention of orthodontic enamel demineralization: A systematic review with meta-analyses. Orthod Craniofac Res. 2019 Nov;22(4):225-235. doi: 10.1111/ocr.12322. Epub 2019 May 27.
PubMed 31081584Mehta A, Paramshivam G, Chugh VK, Singh S, Halkai S, Kumar S. Effect of light-curable fluoride varnish on enamel demineralization adjacent to orthodontic brackets: an in-vivo study. Am J Orthod Dentofacial Orthop. 2015 Nov;148(5):814-20. doi: 10.1016/j.ajodo.2015.05.022.
PubMed 26522042
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Light-cured Fluoride Varnish to Remineralize Post-orthodontic White Spot Lesions and Change the Oral Microbiome: a Double-blind, Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04528134
- Acronym / sponsor ID
- IRB#20-001077
- Conditions
- Dental Caries, Dental Plaque, Dental White Spot
- Keywords
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Orthodontic treatment is common in teenagers, which typically involve the attachment of metal brackets to the teeth. These brackets often impede proper oral hygiene, leading to plaque accumulation and the development of white spots lesions (the early stage of cavity development). Our study aims to investigate the efficacy of different commercially available fluoride varnishes to treat these white spot lesions after the completion of orthodontic treatment and evaluate their effect on the oral microbiome.
Target enrollment is 120 subjects. The study will follow a split-mouth design, with each subject receiving different treatment on the left and right sides of their mouth. The subjects will be randomized into 3 groups, with each group receiving two of the following three options: placebo varnish, traditional sodium fluoride varnish, and a resin-modified glass ionomer light-cured fluoride varnish. There will be 4 total visits for this study:
Baseline (day 0): Oral health assessed, plaque collected, intraoral photos taken, dental cleaning performed, DiagnoDent measurements taken, varnishes applied T1 (day 30): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T2 (day 90): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T3 (day 180): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, dental cleaning performed
Participants will be instructed to use regular fluoridated toothpaste and floss twice per day for the duration of the study.
Detailed description
- Orthodontic patients ages 12-27 (target 120 subjects) nearing the end of treatment with metal braces at the UCLA Orthodontic Clinic will be recruited.
- Patients will be consented by the investigators or an eligible and trained orthodontic resident.
- Participants will be assigned into one of three groups via stratified permuted block randomization. The groups will receive treatment as follows in a split-mouth study design: Group 1 - extended contact varnish on upper left and lower right teeth, 5% fluoride varnish on upper right and lower left teeth Group 2 - placebo varnish on upper left and lower right teeth, extended contact varnish on upper right and lower left teeth Group 3 - 5% fluoride varnish on upper left and lower right teeth, placebo varnish on upper right and lower left teeth
- Shortly after a subject's braces are removed, each subject will fill out an oral health questionnaire and the investigators will use Trace Plaque Disclosing Liquid (a safe, commercially available product) to visualize the plaque. Intraoral photos of only the teeth surfaces will be taken. Dental plaque samples will be collected from buccal surfaces of the teeth. The plaque will be collected with a sterile dental instrument and carefully deposited into a sterile plastic collection tube containing a nutrient solution for the bacteria. After collection, the samples will be taken to the laboratory for further analysis and no subject identifiers will be used. The samples will be plated and total DNA from each will be extracted, and sequencing analysis will be performed in order to determine the relative abundance of each species in the samples.
- A professional cleaning will be done of the subjects teeth to remove all remaining plaque and calculus buildup on the teeth.
- After the cleaning, the subject will rinse with water and a second set of intraoral photos will be taken. The teeth will then be air dried for 15 seconds, and a third set of intraoral photos will be taken.
- The extent of the demineralized white spot lesions will be quantitatively assessed using the DiagnoDent, where a laser is shined on the teeth and the fluorescence is measured to assess the depth/severity of the demineralization.
- The study varnishes will be applied to the patient's teeth (according to the manufacturer's instructions), consistent with their group allocation.
- The patient will be given written post-op instructions, including oral hygiene instructions to use OTC sodium fluoride toothpaste and a manual toothbrush. The subjects will be asked to refrain from using adjunctive fluoride products (such as mouthwash) for the duration of the study. Since all subjects will receive another professional cleaning at their 6-month visit (consistent with the standard of care to receive professional cleanings every 6 months), they will be asked to not receive additional dental cleanings from outside providers.
- Subjects will return to the clinic after 30, 90, and 180 days. At each appointment, they will have their plaque disclosed with Trace Plaque Disclosing solution, have 3 sets of intraoral photos taken (with plaque, with clean/moist teeth, and with clean/dry teeth), have the white spot lesion severity measured with the DiagnoDent, and have the varnishes reapplied to their teeth (except at the last, where the varnish will not be reapplied).
- At the final visit (day 180), subjects will receive a professional dental cleaning after the photos have been assessed.
- After study completion, blinded investigators will use the intraoral photos to (1) assess the extent of plaque using various plaque indices, and (2) assess the severity of white spot lesions using various visual indices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomized into one of 3 groups, each of which will receive two of the following three interventions: extended contact varnish, traditional fluoride varnish, placebo varnish. Subjects will receive the interventions in a split-mouth design, with one treatment on half of their teeth and another treatment on the other half of their teeth.
| Arm | Type | Receives |
|---|---|---|
| Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish | Experimental | Device: Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish, Device: 5% Sodium Fluoride VarnishThis group will receive extended contact (XT) varnish on their upper left and lower right teeth, and traditional 5% sodium fluoride varnish on their upper right and lower left teeth. |
| Placebo Varnish/Extended Contact RMGI Varnish | Experimental | Device: Extended Contact RMGI (Resin-modified Glass Ionomer) VarnishThis group will receive placebo varnish on their upper left and lower right teeth, and extended contact (XT) varnish on their upper right and lower left teeth. |
| 5% Sodium Fluoride Varnish/Placebo Varnish | Active comparator | Device: 5% Sodium Fluoride VarnishThis group will receive traditional 5% sodium fluoride varnish on their upper left and lower right teeth, and placebo varnish on their upper right and lower left teeth. |
Who may qualify
- Ages
- 12 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Males and females, 12-17 years of age, inclusive, at the time the Assent and Informed Consent Form is signed
- Systemically healthy, as determined by the investigator (in consultation with the Medical Monitor, as needed), based on medical history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during screening
- Is approaching the end of their orthodontic treatment using metal fixed oral appliances (brackets) on at least the maxillary arch
- Subject has at least two visible white spot lesions at the time of recruitment on teeth treated with fixed oral appliances
- Subject is willing to use only oral care products that fall within the standard of care (manual toothbrush and sodium fluoride toothpaste) for the duration of the study.
Key exclusion criteria (6 listed)
- Advanced periodontal disease
- Medical condition (e.g. artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
- Pathologic lesions of the oral cavity (suspected or confirmed)
- Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the investigators could influence the study outcome, within 30 days prior to screening.
- Presence of any condition or concurrent illness, which in the opinion of the investigators, would compromise normal immune function ((e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results
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 |
|---|---|---|
| Extended Contact RMGI (Resin-modified Glass Ionomer) VarnishAlso: 3M™ Vanish™ XT Extended Contact VarnishThis is a light-cured, durable coating that forms an immediate layer of protection that releases fluoride, calcium and phosphate and can be recharged with fluoride by using fluoride-containing products over the 6-month life of the product. | Device | Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish, Placebo Varnish/Extended Contact RMGI Varnish |
| 5% Sodium Fluoride VarnishAlso: Henry Schein Acclean 5% Sodium Fluoride VarnishThis is a 5% Sodium Fluoride varnish that hardens on the teeth upon contact with saliva. | Device | 5% Sodium Fluoride Varnish/Placebo Varnish, Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish |
Primary outcome
White Spot Lesion Severity
Time frame: 6 months
Assessed change in severity of white spots on the teeth as measured by the DiagnoDent, which uses quantitative light-induced fluorescence to assess the depth/severity of enamel demineralization. The DiagnoDent gives a score from 0-100, with 100 indicating the most demineralization (worse outcome) and 0 indicating the least demineralization (best outcome).
4 secondary outcomes
Dental Plaque Levels
Time frame: 6 months
Microbial Load
Time frame: 6 months
Plaque and Saliva Microbial Colonization of S. Mutans
Time frame: 6 months
White Spot Lesion Clinical Appearance
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27793169Klaus K, Eichenauer J, Sprenger R, Ruf S. Oral microbiota carriage in patients with multibracket appliance in relation to the quality of oral hygiene. Head Face Med. 2016 Oct 28;12(1):28. doi: 10.1186/s13005-016-0125-x.
- Background: PubMed 24945514Freitas AO, Marquezan M, Nojima Mda C, Alviano DS, Maia LC. The influence of orthodontic fixed appliances on the oral microbiota: a systematic review. Dental Press J Orthod. 2014 Mar-Apr;19(2):46-55. doi: 10.1590/2176-9451.19.2.046-055.oar.
- Background: PubMed 26759794Sundararaj D, Venkatachalapathy S, Tandon A, Pereira A. Critical evaluation of incidence and prevalence of white spot lesions during fixed orthodontic appliance treatment: A meta-analysis. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):433-9. doi: 10.4103/2231-0762.167719.
- Background: PubMed 31081584Tasios T, Papageorgiou SN, Papadopoulos MA, Tsapas A, Haidich AB. Prevention of orthodontic enamel demineralization: A systematic review with meta-analyses. Orthod Craniofac Res. 2019 Nov;22(4):225-235. doi: 10.1111/ocr.12322. Epub 2019 May 27.
- Background: PubMed 26522042Mehta A, Paramshivam G, Chugh VK, Singh S, Halkai S, Kumar S. Effect of light-curable fluoride varnish on enamel demineralization adjacent to orthodontic brackets: an in-vivo study. Am J Orthod Dentofacial Orthop. 2015 Nov;148(5):814-20. doi: 10.1016/j.ajodo.2015.05.022.
- Individual participant dataSharing planned: No. Only de-identified and aggregate data will be made available to researchers outside the study team.
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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.
Tyler Brennan, DDS principal investigator
University of California, Los Angeles
Renate Lux, PhD study chair
University of California, Los Angeles
Nini Tran, DDS, PhD study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish and 5% Sodium Fluoride Varnish in people with Dental Caries and Dental Plaque, run by University of California, Los Angeles 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 9 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: finished, as of the sponsor's last update on 9 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2026). 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?
White Spot Lesion Severity (time frame: 6 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 NCT04528134, which also lists 5 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 9 Jul 2026.