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

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 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.

Timeline

Start

2013-05

Primary completion

2016-10

Completion

2016-10

Publications

• Results 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.
• Results 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.
• Results 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.
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• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications