Dental White SpotsPhase 4GC-WSNCT02424097
MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study
A Phase 4 study testing CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste and 1,100pm F-toothpaste and 0.5%NaF rinse in people with Dental White Spots and Dental Caries, run by University of California, San Francisco at 1 site in United States.
Trial summary
The objective of this clinical study is to evaluate the efficacy of multiple applications of MI Varnish in combination with MI Paste Plus in caries protection and remineralization in comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse recommendation) in orthodontic patients in a… Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental White Spots, Dental Caries
- What is being tested?
- CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste and 1,100pm F-toothpaste and 0.5%NaF rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 2016
- Phase
- Phase 4
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- age 11 or older,
- good health,
- either gender
- present with at least two active white spot lesions on his/her anterior teeth at the start of the study
- have a moderate or high caries risk according to CAMBRA (Caries Management By Risk Assessment) rules
- require at least 12 additional months of full fixed appliance therapy from the time they are recruited for the study
Show all 13Show fewer
- able to cooperate for treatment in the dental chair and follow at-home instructions
- have an understanding of the study
- willing to comply with all study procedures and protocols
- patient participant is able to provide written informed consent in English; if the participant is a minor, the parent/guardian is able to provide written informed consent in English and the patient participant is able to provide written assent in English
- patient participant or if a minor, the parent/guardian, is willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research
- verifiable records of bonding with Transbond Plus Self-Etching Primer (3M Unitek, Monrovia, CA) and Transbond Light Cure Adhesive or similar products
- verifiable records that "ProSeal" has not been applied at any time during the orthodontic treatment
Who cannot join
- untreated cavitated lesions
- extensive composite fillings on buccal surfaces of front teeth/first bicuspids or more than one dental crown on front teeth/first bicuspids
- has sealants or fluoride releasing cements on the buccal surface of the anterior teeth
- in-office fluoride treatment in the last three months
- history of using any products containing CCP-ACP (casein phosphopeptides and amorphous calcium phosphate; MI paste, chewing gums or candies, etc.), prescription Fluoride products, and Chlorhexidine use in the last three months
- intrinsic or extremely heavy extrinsic staining
Show all 19Show fewer
- any signs of fluorosis in the dentition
- any signs of morphologic/anatomical/developmental deviations in the teeth
- previous history of in office bleaching treatment
- subject not willing to stop the use of any other oral hygiene product than those prescribed/suggested
- has underlying systemic disease which could alter enamel composition or formation
- suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
- use of medication causing dry mouth (extreme high caries risk)
- subject is pregnant or lactating
- milk protein allergy
- any illness/condition that the investigator feels will affect the study outcome
- will leave the area and will not be available for recall visits
- subjects who are not willing to inform us about prospective visits of other dentist and will not allow us to discuss treatment with those dentist
- subjects who are not willing to refrain from any additional professional tooth cleaning or any additional Fluoride application.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF School of Dentistry - Dental Offices in Bay Area
San Francisco, California, 94143
About this study
The objective of this clinical study is to evaluate the efficacy of multiple applications of MI Varnish in combination with MI Paste Plus in caries protection and remineralization in comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse recommendation) in orthodontic patients in a randomized, single blind, prospective, controlled clinical trial over 12 months.
The effect will be measured by white spot lesion regression and prevention as lesion count. Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme (primary outcome), International Caries Detection and Assessment System (ICDAS), the caries lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior teeth with orthodontic brackets in treatment and control groups.
Read the detailed description
The study is designed as randomized, single blind, prospective, clinical trial over 12 months. The subjects for this study will be recruited from the University of California at San Francisco UCSF, School of Dentistry, Orthodontic Clinic.
Participants in the study will be patients, who are in orthodontic treatment or will start orthodontic treatment; subjects must have full fixed appliances, with brackets bonded to the buccal surfaces of the maxillary and mandibular incisors, canines and first bicuspids. Subjects will be of moderate or high caries risk according to Caries Risk Assessment and ATP (Adenosine triphosphate) bacteria testing. Subjects will present with at least two active white spot lesions on his/her anterior teeth at the start of the study. The age limitation is ≥ 11 years.
The subjects will be randomly assigned to 1) Experimental group: MI Varnish and MI Paste Plus or 2) Control standard of care group: 1,100 ppm Fluoride tooth paste and recommendation to use OTC (Over-the-counter) Fluoride-rinse in the evening at home.
The clinical study investigator will evaluate the labial/buccal surfaces of upper and lower anterior teeth (first bicuspid to first bicuspid) for white spot lesions (WSL) at baseline and at the end of 3, 6, and 12 months. Newly formed lesions and changes in existing white spot lesions will be documented (using Enamel Decalcification Index (EDI), ICDAS II, light digital photographs and blue fluorescence photography SOPROLIFE and QLF- Quantitative Light Fluorescence).
All subjects will receive one professional tooth cleaning at baseline and at each other evaluation office visit to allow WSL evaluation (cleaning with ultrasonic device, and prophylaxis brush) and treatment application.
- Conditions
- Dental White Spots, Dental Caries
- Being tested
- CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste, 1,100pm F-toothpaste and 0.5%NaF rinse
- Keywords
- Prevention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride pasteDrug
MI Paste \& MI Varnish- in-office:
varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)
- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray
1,100pm F-toothpaste and 0.5%NaF rinseDrug
Standard of care at-home:
Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)
| Study group | Role | What they receive |
|---|---|---|
| MI Paste & MI Varnish | Experimental | MI past will be applied by the patient every night; MI varnish will be applied every three months in the office Receives: Drug: CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste |
| Standard of Care | Active comparator | Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended Receives: Drug: 1,100pm F-toothpaste and 0.5%NaF rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)
The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering <50% of the area, 2 = decalcification covering > 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12.
16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192.
A mean over all participants in one group was calculated. A higher score means a worse outcome.
Measured: Baseline and 12-months
Secondary outcomes (1)
Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)
The International Caries Detection and Assessment System (ICDAS II) is a standardized method of caries lesion assessment.The score is based on apparent lesion severity, with scores from 0 to 6.The buccal surface of each tooth was divided into 4 quadrants, and for each quadrant a score was assigned with ICDAS scores: 0 = sound, 1 = first visual change in enamel, after air drying, 2 = distinct demineralization visual change in enamel, 3 = localized enamel breakdown due to caries with no visible dentin, 4 = surface with underlying dark shadow from dentin with or without enamel breakdown, 5 = distinct cavity with visible dentin, 6 = extensive cavity with visible dentin.
The ICDAS scores were calculated as the sum of the highest ICDAS scores assigned to each examined tooth per subject. 16 teeth per subject were evaluated, thus, for each subject the value can range between 0 and 96.
A mean over all participants in one group was calculated. A higher score means a worse outcome.
Measured: Baseline and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMay 2013
- Primary completionOct 2016
- Study completionOct 2016
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 (27)Papers the sponsor has linked to this study.
- Other trials for Dental White SpotsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rechmann, DMD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424097
- Sponsor's protocol ID
- GCAmerica-WS
- Acronym
- GC-WS
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2015
- Last updated
- 22 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mitchell L. Decalcification during orthodontic treatment with fixed appliances--an overview. Br J Orthod. 1992 Aug;19(3):199-205. doi: 10.1179/bjo.19.3.199. No abstract available.
PubMed 1390575Geiger AM, Gorelick L, Gwinnett AJ, Griswold PG. The effect of a fluoride program on white spot formation during orthodontic treatment. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):29-37. doi: 10.1016/0889-5406(88)90190-4. No abstract available.
PubMed 3276146Richter AE, Arruda AO, Peters MC, Sohn W. Incidence of caries lesions among patients treated with comprehensive orthodontics. Am J Orthod Dentofacial Orthop. 2011 May;139(5):657-64. doi: 10.1016/j.ajodo.2009.06.037.
PubMed 21536209Magness WS, Shannon IL, West DC. Office-applied fluoride treatments for orthodontic patients. J Dent Res. 1979 Apr;58(4):1427. doi: 10.1177/00220345790580042401. No abstract available.
PubMed 285114Stratemann MW, Shannon IL. Control of decalcification in orthodontic patients by daily self-administered application of a water-free 0.4 per cent stannous fluoride gel. Am J Orthod. 1974 Sep;66(3):273-9. doi: 10.1016/0002-9416(74)90291-7. No abstract available.
PubMed 4528489Mizrahi E. Surface distribution of enamel opacities following orthodontic treatment. Am J Orthod. 1983 Oct;84(4):323-31. doi: 10.1016/s0002-9416(83)90348-2.
PubMed 6605091Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.
PubMed 6758594Zachrisson BU, Zachrisson S. Caries incidence and oral hygiene during orthodontic treatment. Scand J Dent Res. 1971;79(6):394-401. doi: 10.1111/j.1600-0722.1971.tb02028.x. No abstract available.
PubMed 5288673Gorton J, Featherstone JD. In vivo inhibition of demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2003 Jan;123(1):10-4. doi: 10.1067/mod.2003.47.
PubMed 12532056Zachrisson BU. Fluoride application procedures in orthodontic practice, current concepts. Angle Orthod. 1975 Jan;45(1):72-81. doi: 10.1043/0003-3219(1975)0452.0.CO;2.
PubMed 1054935Geiger AM, Gorelick L, Gwinnett AJ, Benson BJ. Reducing white spot lesions in orthodontic populations with fluoride rinsing. Am J Orthod Dentofacial Orthop. 1992 May;101(5):403-7. doi: 10.1016/0889-5406(92)70112-N.
PubMed 1590288Benson PE, Parkin N, Millett DT, Dyer FE, Vine S, Shah A. Fluorides for the prevention of white spots on teeth during fixed brace treatment. Cochrane Database Syst Rev. 2004;(3):CD003809. doi: 10.1002/14651858.CD003809.pub2.
PubMed 15266503Ogaard B, Alm AA, Larsson E, Adolfsson U. A prospective, randomized clinical study on the effects of an amine fluoride/stannous fluoride toothpaste/mouthrinse on plaque, gingivitis and initial caries lesion development in orthodontic patients. Eur J Orthod. 2006 Feb;28(1):8-12. doi: 10.1093/ejo/cji075. Epub 2005 Oct 17.
PubMed 16230329Andersson A, Skold-Larsson K, Hallgren A, Petersson LG, Twetman S. Effect of a dental cream containing amorphous cream phosphate complexes on white spot lesion regression assessed by laser fluorescence. Oral Health Prev Dent. 2007;5(3):229-33.
PubMed 17977295Beerens MW, van der Veen MH, van Beek H, ten Cate JM. Effects of casein phosphopeptide amorphous calcium fluoride phosphate paste on white spot lesions and dental plaque after orthodontic treatment: a 3-month follow-up. Eur J Oral Sci. 2010 Dec;118(6):610-7. doi: 10.1111/j.1600-0722.2010.00780.x.
PubMed 21083623
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study
- ClinicalTrials.gov ID
- NCT02424097
- Acronym / sponsor ID
- GC-WS / GCAmerica-WS
- Conditions
- Dental White Spots, Dental Caries
- Keywords
- Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Posted 24 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to evaluate the efficacy of multiple applications of MI Varnish in combination with MI Paste Plus in caries protection and remineralization in comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse recommendation) in orthodontic patients in a randomized, single blind, prospective, controlled clinical trial over 12 months.
The effect will be measured by white spot lesion regression and prevention as lesion count. Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme (primary outcome), International Caries Detection and Assessment System (ICDAS), the caries lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior teeth with orthodontic brackets in treatment and control groups.
Detailed description
The study is designed as randomized, single blind, prospective, clinical trial over 12 months. The subjects for this study will be recruited from the University of California at San Francisco UCSF, School of Dentistry, Orthodontic Clinic.
Participants in the study will be patients, who are in orthodontic treatment or will start orthodontic treatment; subjects must have full fixed appliances, with brackets bonded to the buccal surfaces of the maxillary and mandibular incisors, canines and first bicuspids. Subjects will be of moderate or high caries risk according to Caries Risk Assessment and ATP (Adenosine triphosphate) bacteria testing. Subjects will present with at least two active white spot lesions on his/her anterior teeth at the start of the study. The age limitation is ≥ 11 years.
The subjects will be randomly assigned to 1) Experimental group: MI Varnish and MI Paste Plus or 2) Control standard of care group: 1,100 ppm Fluoride tooth paste and recommendation to use OTC (Over-the-counter) Fluoride-rinse in the evening at home.
The clinical study investigator will evaluate the labial/buccal surfaces of upper and lower anterior teeth (first bicuspid to first bicuspid) for white spot lesions (WSL) at baseline and at the end of 3, 6, and 12 months. Newly formed lesions and changes in existing white spot lesions will be documented (using Enamel Decalcification Index (EDI), ICDAS II, light digital photographs and blue fluorescence photography SOPROLIFE and QLF- Quantitative Light Fluorescence).
All subjects will receive one professional tooth cleaning at baseline and at each other evaluation office visit to allow WSL evaluation (cleaning with ultrasonic device, and prophylaxis brush) and treatment application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI Paste & MI Varnish | Experimental | Drug: CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride pasteMI past will be applied by the patient every night; MI varnish will be applied every three months in the office |
| Standard of Care | Active comparator | Drug: 1,100pm F-toothpaste and 0.5%NaF rinseSubjects will use at home regal toothpaste every night and F-mouth rinse as recommended |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- age 11 or older,
- good health,
- either gender
- present with at least two active white spot lesions on his/her anterior teeth at the start of the study
- have a moderate or high caries risk according to CAMBRA (Caries Management By Risk Assessment) rules
Key exclusion criteria (19 listed)
- untreated cavitated lesions
- extensive composite fillings on buccal surfaces of front teeth/first bicuspids or more than one dental crown on front teeth/first bicuspids
- has sealants or fluoride releasing cements on the buccal surface of the anterior teeth
- in-office fluoride treatment in the last three months
- history of using any products containing CCP-ACP (casein phosphopeptides and amorphous calcium phosphate; MI paste, chewing gums or candies, etc.), prescription Fluoride products, and Chlorhexidine use in the last three months
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 |
|---|---|---|
| CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride pasteMI Paste \& MI Varnish- in-office: varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications) - at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray | Drug | MI Paste & MI Varnish |
| 1,100pm F-toothpaste and 0.5%NaF rinseStandard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day) | Drug | Standard of Care |
Primary outcome
Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)
Time frame: Baseline and 12-months
The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering <50% of the area, 2 = decalcification covering > 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12. 16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192. A mean over all participants in one group was calculated. A higher score means a worse outcome.
1 secondary outcome
Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)
Time frame: Baseline and 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 1390575Mitchell L. Decalcification during orthodontic treatment with fixed appliances--an overview. Br J Orthod. 1992 Aug;19(3):199-205. doi: 10.1179/bjo.19.3.199. No abstract available.
- Results publication: PubMed 3276146Geiger AM, Gorelick L, Gwinnett AJ, Griswold PG. The effect of a fluoride program on white spot formation during orthodontic treatment. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):29-37. doi: 10.1016/0889-5406(88)90190-4. No abstract available.
- Results publication: PubMed 21536209Richter AE, Arruda AO, Peters MC, Sohn W. Incidence of caries lesions among patients treated with comprehensive orthodontics. Am J Orthod Dentofacial Orthop. 2011 May;139(5):657-64. doi: 10.1016/j.ajodo.2009.06.037.
- Results publication: PubMed 285114Magness WS, Shannon IL, West DC. Office-applied fluoride treatments for orthodontic patients. J Dent Res. 1979 Apr;58(4):1427. doi: 10.1177/00220345790580042401. No abstract available.
- Results publication: PubMed 4528489Stratemann MW, Shannon IL. Control of decalcification in orthodontic patients by daily self-administered application of a water-free 0.4 per cent stannous fluoride gel. Am J Orthod. 1974 Sep;66(3):273-9. doi: 10.1016/0002-9416(74)90291-7. No abstract available.
- Results publication: PubMed 6605091Mizrahi E. Surface distribution of enamel opacities following orthodontic treatment. Am J Orthod. 1983 Oct;84(4):323-31. doi: 10.1016/s0002-9416(83)90348-2.
- Results publication: PubMed 6758594Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.
- Results publication: PubMed 5288673Zachrisson BU, Zachrisson S. Caries incidence and oral hygiene during orthodontic treatment. Scand J Dent Res. 1971;79(6):394-401. doi: 10.1111/j.1600-0722.1971.tb02028.x. No abstract available.
- Results publication: PubMed 12532056Gorton J, Featherstone JD. In vivo inhibition of demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2003 Jan;123(1):10-4. doi: 10.1067/mod.2003.47.
- Results publication: PubMed 1054935Zachrisson BU. Fluoride application procedures in orthodontic practice, current concepts. Angle Orthod. 1975 Jan;45(1):72-81. doi: 10.1043/0003-3219(1975)0452.0.CO;2.
- Results publication: PubMed 1590288Geiger AM, Gorelick L, Gwinnett AJ, Benson BJ. Reducing white spot lesions in orthodontic populations with fluoride rinsing. Am J Orthod Dentofacial Orthop. 1992 May;101(5):403-7. doi: 10.1016/0889-5406(92)70112-N.
- Results publication: PubMed 15266503Benson PE, Parkin N, Millett DT, Dyer FE, Vine S, Shah A. Fluorides for the prevention of white spots on teeth during fixed brace treatment. Cochrane Database Syst Rev. 2004;(3):CD003809. doi: 10.1002/14651858.CD003809.pub2.
- Individual participant dataSharing planned: No
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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 Rechmann, DMD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste and 1,100pm F-toothpaste and 0.5%NaF rinse in people with Dental White Spots and Dental Caries, run by University of California, San Francisco 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 13 inclusion and 19 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 22 Apr 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.
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?
Yes. Results are posted in the registry (first posted 24 Dec 2018). 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?
Change in White Spot Lesions Count - Enamel Decalcification Index (EDI) (time frame: Baseline and 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 NCT02424097, which also lists 27 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 22 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.