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

Not Applicable

Completed

• Conditions: Remineralization Effect of the Varnish on White Spot Lesions
• Interventions: Other: MI varnish

• Registration Number: NCT03731403
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-11-03
• Study First Submitted QC: 2018-11-03
• Study First Posted: 2018-11-06
• Study Start: 2019-03-01
• Primary Completion: 2020-03-01
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Profluorid Varnish	MI varnish	-
MI Varnish	MI varnish	-

Primary Outcome Measures

Name	Time	Method
Caries activity	Change from base line, after application at 3, 6, 9 last follow up 12 months	Measured by ICDAS II

Secondary Outcome Measures

Name	Time	Method
Remineralization	Change from base line, after application at 3, 6, 9 last follow up 12 months	Measured by EDI

Trial Locations

Locations (1)

Faculty of Dentistry- Cairo University; 🇪🇬 Cairo, Egypt