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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard of Care | Active Comparator | Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lesion Activity, Nyvad Criteria | WS lesion activity will be determined using the Nyvad criteria; | Baseline and 12-months |
| Change in SOPROLIFE | fluorescence measurements using blue light fluorescence make WSLs visible for scoring; |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Rechmann, DMD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF School of Dentistry - Dental Offices in Bay Area | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1390575 | Result | 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. | |
| 3276146 | Result | Geiger 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MI Paste & MI Varnish | MI past will be applied by the patient every night; MI varnish will be applied every three months in the office CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste: 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 |
| FG001 | Standard of Care | Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended 1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MI Paste & MI Varnish | MI past will be applied by the patient every night; MI varnish will be applied every three months in the office CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | enamel decalcification index (EDI) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-months |
|
1 year, 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MI Paste & MI Varnish | MI past will be applied by the patient every night; MI varnish will be applied every three months in the office CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Rechmann | UCSF - School of Dentistry | 415 514 3225 | Peter.Rechmann@ucsf.edu |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C447032 | casein phosphopeptide-amorphous calcium phosphate nanocomplex |
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|
| 1,100pm F-toothpaste and 0.5%NaF rinse | Drug | Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day) |
|
| Baseline and 12-months |
| Baseline and 12-months |
| Change in Quantitative Light Fluorescence (QLF) | Quantitative Light Fluorescence will be used to evaluate the WSL | Baseline and 12-months |
| 21536209 | Result | Richter 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. |
| 285114 | Result | Magness 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. |
| 4528489 | Result | Stratemann 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. |
| 6605091 | Result | Mizrahi 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. |
| 6758594 | Result | Gorelick 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. |
| 5288673 | Result | Zachrisson 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. |
| 12532056 | Result | Gorton 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. |
| 1054935 | Result | Zachrisson 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. |
| 1590288 | Result | Geiger 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. |
| 15266503 | Result | Benson 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. |
| 16230329 | Result | Ogaard 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. |
| 17977295 | Result | Andersson 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. |
| 21083623 | Result | Beerens 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. |
| 9294493 | Result | Reynolds EC. Remineralization of enamel subsurface lesions by casein phosphopeptide-stabilized calcium phosphate solutions. J Dent Res. 1997 Sep;76(9):1587-95. doi: 10.1177/00220345970760091101. |
| 17634723 | Result | Oshiro M, Yamaguchi K, Takamizawa T, Inage H, Watanabe T, Irokawa A, Ando S, Miyazaki M. Effect of CPP-ACP paste on tooth mineralization: an FE-SEM study. J Oral Sci. 2007 Jun;49(2):115-20. doi: 10.2334/josnusd.49.115. |
| 17561043 | Result | Sudjalim TR, Woods MG, Manton DJ, Reynolds EC. Prevention of demineralization around orthodontic brackets in vitro. Am J Orthod Dentofacial Orthop. 2007 Jun;131(6):705.e1-9. doi: 10.1016/j.ajodo.2006.09.043. |
| 14738126 | Result | Cai F, Shen P, Morgan MV, Reynolds EC. Remineralization of enamel subsurface lesions in situ by sugar-free lozenges containing casein phosphopeptide-amorphous calcium phosphate. Aust Dent J. 2003 Dec;48(4):240-3. doi: 10.1111/j.1834-7819.2003.tb00037.x. |
| 20887516 | Result | Uysal T, Amasyali M, Ozcan S, Koyuturk AE, Akyol M, Sagdic D. In vivo effects of amorphous calcium phosphate-containing orthodontic composite on enamel demineralization around orthodontic brackets. Aust Dent J. 2010 Sep;55(3):285-91. doi: 10.1111/j.1834-7819.2010.01236.x. |
| 23158136 | Result | Wang JX, Yan Y, Wang XJ. Clinical evaluation of remineralization potential of casein phosphopeptide amorphous calcium phosphate nanocomplexes for enamel decalcification in orthodontics. Chin Med J (Engl). 2012 Nov;125(22):4018-21. |
| 22051486 | Result | Robertson MA, Kau CH, English JD, Lee RP, Powers J, Nguyen JT. MI Paste Plus to prevent demineralization in orthodontic patients: a prospective randomized controlled trial. Am J Orthod Dentofacial Orthop. 2011 Nov;140(5):660-8. doi: 10.1016/j.ajodo.2010.10.025. |
| 23273358 | Result | Huang GJ, Roloff-Chiang B, Mills BE, Shalchi S, Spiekerman C, Korpak AM, Starrett JL, Greenlee GM, Drangsholt RJ, Matunas JC. Effectiveness of MI Paste Plus and PreviDent fluoride varnish for treatment of white spot lesions: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Jan;143(1):31-41. doi: 10.1016/j.ajodo.2012.09.007. |
| 20348890 | Result | Bader JD. Casein phosphopeptide-amorphous calcium phosphate shows promise for preventing caries. Evid Based Dent. 2010;11(1):11-2. doi: 10.1038/sj.ebd.6400701. |
| 10343087 | Result | Nyvad B, Machiulskiene V, Baelum V. Reliability of a new caries diagnostic system differentiating between active and inactive caries lesions. Caries Res. 1999 Jul-Aug;33(4):252-60. doi: 10.1159/000016526. |
| 20020086 | Result | Terrer E, Koubi S, Dionne A, Weisrock G, Sarraquigne C, Mazuir A, Tassery H. A new concept in restorative dentistry: light-induced fluorescence evaluator for diagnosis and treatment. Part 1: Diagnosis and treatment of initial occlusal caries. J Contemp Dent Pract. 2009 Nov 1;10(6):E086-94. |
| 22502564 | Result | Rechmann P, Charland D, Rechmann BM, Featherstone JD. Performance of laser fluorescence devices and visual examination for the detection of occlusal caries in permanent molars. J Biomed Opt. 2012 Mar;17(3):036006. doi: 10.1117/1.JBO.17.3.036006. |
| BG001 | Standard of Care | Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended 1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MI Paste & MI Varnish |
MI past will be applied by the patient every night; MI varnish will be applied every three months in the office CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste: 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 |
| OG001 | Standard of Care | Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended 1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day) |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12-months |
|
|
|
| Other Pre-specified | Change in Lesion Activity, Nyvad Criteria | WS lesion activity will be determined using the Nyvad criteria; | Not Posted | Baseline and 12-months | Participants |
| Other Pre-specified | Change in SOPROLIFE | fluorescence measurements using blue light fluorescence make WSLs visible for scoring; | Not Posted | Baseline and 12-months | Participants |
| Other Pre-specified | Change in Quantitative Light Fluorescence (QLF) | Quantitative Light Fluorescence will be used to evaluate the WSL | Not Posted | Baseline and 12-months | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Standard of Care | Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended 1,100pm F-toothpaste and 0.5%NaF rinse: Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day) | 0 | 20 | 0 | 20 | 0 | 20 |
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