Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth

Hams Hamed Abdelrahman

Status: Completed

Conditions: White Spot Lesion

Treatments: Other: Fluoride varnish (DURAFLOR; Other: Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR

Study type: Interventional

Funder types: Other

Identifiers

NCT05721586

P11-4_2020

Details and patient eligibility

About

Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimally invasive therapy using Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.

Enrollment: 24 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children with high caries risk with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1, 2 or 3

Exclusion criteria

• Children with systemic diseases
• Teeth with cavitated lesion involving dentin and enamel defects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR)

Experimental group

Treatment:

Other: Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR

Fluoride Varnish (DURAFLOR) only

Active Comparator group

Treatment:

Other: Fluoride varnish (DURAFLOR