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

Remineralization Effect of the Varnish on White Spot Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731403
• Other study ID #: CEBD-CU-28-10-2017
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Dental Caries
• Remineralization Effect of the Varnish on White Spot Lesions

Intervention

Other:
• MI varnish
CPP- ACP with 5 % sodium fluoride GC

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry- Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries activity	Measured by ICDAS II	Change from base line, after application at 3, 6, 9 last follow up 12 months
Secondary	Remineralization	Measured by EDI	Change from base line, after application at 3, 6, 9 last follow up 12 months