Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth

Nourhan M.Aly

Status and phase: Completed; Phase 2

Conditions: White Spot Lesion

Treatments: Drug: Duraphat; Drug: CPP-ACP

Study type: Interventional

Funder types: Other

Identifiers

NCT03865680

CPP-ACP FV on remineralization

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness of Casein phosphopeptide-amorphous calcium phosphate fluoride varnish (CPP-ACP FV) in comparison to fluoride varnish (FV) as a remineralizing agent for white spot lesions in primary teeth (WSLs).

Full description

The study is a two parallel arms double blinded randomized controlled clinical trial. A total of 180 WSL in primary teeth in chikdren aged 2-5 y and satisfying the inclusion criteria were selected. Patients will be randomly allocated into 2 groups allocated to two varnishes: study group: CPP-ACP FV (MI varnish), Control group FV (Duraphat). Both fluoride varnishes applications are applied with identical intensive protocols every 2 weeks for 6 weeks. The application of each varnish will be according to manufacturer's instructions. The operator is not blinded to treatment type. Only the participants and statistician are blinded to treatment groups. The whole sample (N=180) will be followed up at 6 weeks and at 18 and 30 weeks for Visio-tactile assessment and DIAGNOdent measurements

Enrollment: 180 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy children with no systemic diseases.
• 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 cavitated lesion.
• Selected tooth with enamel defects.
• Participants allergic to milk products.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

MI varnish

Experimental group

Description:

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.

Treatment:

Drug: CPP-ACP

Duraphat Fluoride varnish

Active Comparator group

Description:

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.

Treatment:

Drug: Duraphat