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Remineralization Potential of MI Varnish Versus Fluoride Varnish on White Spot Lesions in Maxillary Primary Incisors

Remineralization Potential of MI Varnish(CPP-ACP and Fluoride) Versus Fluoride Varnish in Controlling White Spot Lesions in Maxillary Primary Incisors: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03731403
Enrollment
60
Registered
2018-11-06
Start date
2019-03-01
Completion date
2020-07-01
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Remineralization Effect of the Varnish on White Spot Lesions

Keywords

Early childhood caries, Casein phosphopeptides-amorphous calcium phosphate, fluoride, remineralization potential, varnish

Brief summary

Remineralization effect of CPP-ACP and Fluoride (MI varnish) versus Fluoride varnish on white spot lesions in maxillary primary incisors

Detailed description

Early childhood caries (ECC) is a very common and consequential chronic disease affecting young children ( Çolak et al., 2013). The prevalence of ECC in Egypt is high, it is about (78%) according to the last Egyptian Report, 2014. ECC begins with white-spot lesions, and caries can progress continuously, leading to complete destruction of the crown. Calcium and phosphate ions are more readily lost for children because lower mineralization of deciduous enamel. The disease usually develops very quickly and causes many childhood health problems, such as caries-related toothache and infection. Demineralization and remineralization are dynamic processes in caries initiation, progression, and reversal. Therefore, regulation of the demineralization- remineralization balance is a key to caries prevention and treatment. The ideal method of increasing remineralization is reconstructing the depleted tissues with hydroxyapatite, which is the same inorganic component as the enamel. Fluoride varnishes have been the standard practice for the professional application of fluoride. Casien PhosphoPeptide (CPP) is a sticky protein that binds and stabilizes calcium and phosphate ions in an amorphous state. CPP-ACP has been shown to adhere to teeth surfaces.

Interventions

CPP- ACP with 5 % sodium fluoride GC

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

1. Children with white spot lesions on their incisors. 2. Age ranging 3-5 years. 3. Good general health.

Exclusion criteria

1\. Chronic use of medications or antibiotics 2. lack of cooperation in the oral examination 3. Allergies to milk protein or benzoate preservatives 4. Presence of oral soft-tissue lesions or enamel hypoplasia at baseline examination, 5. Children who have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period. \-

Design outcomes

Primary

MeasureTime frameDescription
Caries activityChange from base line, after application at 3, 6, 9 last follow up 12 monthsMeasured by ICDAS II

Secondary

MeasureTime frameDescription
RemineralizationChange from base line, after application at 3, 6, 9 last follow up 12 monthsMeasured by EDI

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026