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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05721586
Other study ID # P11-4_2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date May 30, 2021

Study information

Verified date February 2023
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Alexandria Faculty of Dentistry Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in DIAGNOdent readings The measurements with the DIAGNOdent device that provides numerical values from 0 to 99 Baseline, 3 months, and 6 months
Secondary 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.
Baseline, 3 months, and 6 months
Secondary 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.
Baseline, 3 months, and 6 months
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