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

Hams Hamed Abdelrahman24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

White Spot Lesion

Interventions

Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOROTHER

The WSL was Acid etched with phosphoric acid gel 35-37% for 20 seconds, the tooth surface was rinsed with water and then dried afterwards application of CURODONTTM REPAIR

Fluoride varnish (DURAFLOROTHER

A very thin coat of the DURAFLOR varnish was applied by a thin brush which was then allowed to dry for 10 seconds. The varnish hardens on contact with saliva or moisture

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Outcomes

Primary Outcomes

Change in DIAGNOdent readings

The measurements with the DIAGNOdent device that provides numerical values from 0 to 99

Time frame: Baseline, 3 months, and 6 months

Secondary Outcomes

Change in ICDAS II scores

Code 0 Sound tooth surface: Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry. Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow. Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown. Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin. After treatment, the evaluation will be performed as follows.

Time frame: Baseline, 3 months, and 6 months

Change in Nyvad scores

Code 0: Sound - Normal enamel Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque Code 2: Active caries (surface discontinuity) Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye. Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black. Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure.

Time frame: Baseline, 3 months, and 6 months

Data from ClinicalTrials.gov

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