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San Francisco, California 94143


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 - 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 Exclusion Criteria: - 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 - 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.


Study is Available At:


Original ID:

GCAmerica-WS


NCT ID:

NCT02424097


Secondary ID:


Study Acronym:

GC-WS


Brief Title:

MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study


Official Title:

MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

11 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Peter Rechmann, DMD, PhD
Principal Investigator
University of California, San Francisco

Study Dates

Start Date:May 2013
Completion Date:October 2016
Completion Type:Actual
Primary Completion Date:October 2016
Primary Completion Type:Actual
Verification Date:December 2018
Last Changed Date:December 20, 2018
First Received Date:April 15, 2015
First Results Date:October 29, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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,
Outcome Type:Primary Outcome
Measure:Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)
Time Frame:Baseline and 12-months
Safety Issues:False
Description: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 quadra

Study Interventions

Intervention Type:Drug
Name:CPP-ACP 5% sodium fluoride varnish & 900ppm fl
Description: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
Arm Name:MI Paste & MI Varnish
Intervention Type:Drug
Name:1,100pm F-toothpaste and 0.5%NaF rinse
Description:Standard of care at-home: Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)
Arm Name:Standard of Care

Study Arms

Study Arm Type:Active Comparator
Arm Name:Standard of Care
Description:Subjects will use at home regal toothpaste every night and F-mouth rinse as recommended
Study Arm Type:Experimental
Arm Name:MI Paste & MI Varnish
Description:MI past will be applied by the patient every night; MI varnish will be applied every three months in the office

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:22502564
Reference Type:Results Reference
Citation: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.
PMID:20020086
Reference Type:Results Reference
Citation: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.
PMID:10343087
Reference Type:Results Reference
Citation: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.
PMID:20348890
Reference Type:Results Reference
Citation: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.
PMID:23273358
Reference Type:Results Reference
Citation: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.
PMID:22051486
Reference Type:Results Reference
Citation: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.
PMID:23158136
Reference Type:Results Reference
Citation: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.
PMID:20887516
Reference Type:Results Reference
Citation: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.
PMID:14738126
Reference Type:Results Reference
Citation: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.
PMID:17561043
Reference Type:Results Reference
Citation: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.
PMID:17634723
Reference Type:Results Reference
Citation:Reynolds EC. Remineralization of enamel subsurface lesions by casein phosphopeptide-stabilized calcium phosphate solutions. J Dent Res. 1997 Sep;76(9):1587-95.
PMID:9294493
Reference Type:Results Reference
Citation: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.
PMID:21083623
Reference Type:Results Reference
Citation:Andersson A, Sköld-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.
PMID:17977295
Reference Type:Results Reference
Citation:Øgaard 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. Epub 2005 Oct 17.
PMID:16230329
Reference Type:Results Reference
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PMID:15266503
Reference Type:Results Reference
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PMID:1590288
Reference Type:Results Reference
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PMID:1054935
Reference Type:Results Reference
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PMID:12532056
Reference Type:Results Reference
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PMID:5288673
Reference Type:Results Reference
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PMID:6758594
Reference Type:Results Reference
Citation:Mizrahi E. Surface distribution of enamel opacities following orthodontic treatment. Am J Orthod. 1983 Oct;84(4):323-31.
PMID:6605091
Reference Type:Results Reference
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Reference Type:Results Reference
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Reference Type:Results Reference
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PMID:21536209
Reference Type:Results Reference
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Reference Type:Results Reference
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PMID:1390575

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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