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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04401280
Other study ID # WSL treatment
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 1, 2020
Est. completion date June 30, 2021

Study information

Verified date October 2021
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 26 Years
Eligibility Inclusion Criteria: - Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less - Absence of any active periodontal disease. - Written informed consent Exclusion Criteria: - Known hypersensitivity/allergy to study products and/or materials used - teeth having deep carious lesions or extensive restorations - Unwillingness to be randomly assigned to 1 of the 3 treatment groups - Advanced periodontal disease.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BiominF
in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
Novamin
in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
CPP-ACP
applied in accordance with the manufacturer's specifications

Locations

Country Name City State
Egypt Faculty of Dentistry Alexandria

Sponsors (2)

Lead Sponsor Collaborator
Rania Salah Queen Mary University of London

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in White spot lesions dimension Quantified using computer-assisted analysis based on digital intraoral photographs 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Secondary change in lesion fluorescence evaluated using diode laser fluorescence device (Diagnodent) 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
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