Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth
NCT ID: NCT03865680
Last Updated: 2020-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2019-04-28
2020-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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MI varnish
MI Fluoride varnish: 5% sodium fluoride varnish water based, sugar free containing RecaldentTM (CPP-ACP) (GC AMERICA INC.3737 West 127th Street, Alsip, IL 60803 U.S.A). The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions. Participants will receive oral hygiene instructions, prophylaxis without paste.
CPP-ACP
The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.
Duraphat Fluoride varnish
Duraphat Fluoride: varnish 5% sodium fluoride varnish (Colgate, New York, N.Y.). The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions. Participants will receive oral hygiene instructions, prophylaxis without paste.
Duraphat
The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.
Interventions
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CPP-ACP
The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.
Duraphat
The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* High caries risk children with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1,2 or 3
* Completion of a parental consent to participate in the study.
Exclusion Criteria
* Selected tooth with enamel defects.
* Participants allergic to milk products.
3 Years
5 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Clinical Instructor and statistician
Principal Investigators
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Ahmed I Mekky, BDS
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Karin ML Dowidar, PhD
Role: STUDY_DIRECTOR
Alexandria University
Dalia AM Talaat, PhD
Role: STUDY_DIRECTOR
Alexandria University
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
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References
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Willmot DR. White lesions after orthodontic treatment: does low fluoride make a difference? J Orthod. 2004 Sep;31(3):235-42; discussion 202. doi: 10.1179/146531204225022443.
Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.
Cochrane NJ, Shen P, Yuan Y, Reynolds EC. Ion release from calcium and fluoride containing dental varnishes. Aust Dent J. 2014 Mar;59(1):100-5. doi: 10.1111/adj.12144. Epub 2014 Feb 4.
Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
Miglani DC, Beal JF, James PM, Behari SA. The assessment of dental cleanliness status of the primary dentition using a modification of the simplified oral hygiene index(OHIS-M). J Indian Dent Assoc. 1973 Dec;45(12):385-8. No abstract available.
Braga MM, Mendes FM, Ekstrand KR. Detection activity assessment and diagnosis of dental caries lesions. Dent Clin North Am. 2010 Jul;54(3):479-93. doi: 10.1016/j.cden.2010.03.006.
Other Identifiers
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CPP-ACP FV on remineralization
Identifier Type: -
Identifier Source: org_study_id
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