NCT04401280
Completed
Phase 3
Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial
Rania Salah1 site in 1 country60 target enrollmentJune 1, 2020
Overview
- Phase
- Phase 3
- Intervention
- BiominF
- Conditions
- White Spot Lesion of Tooth
- Sponsor
- Rania Salah
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in White spot lesions dimension
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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
Investigators
Rania Salah
Clinical instructor and Principal investigator at conservative dentistry department
Alexandria University
Eligibility Criteria
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.
Arms & Interventions
BiominF®
Test group
Intervention: BiominF
Novamin®
Test group
Intervention: Novamin
CPP-ACP
Control group
Intervention: CPP-ACP
Outcomes
Primary Outcomes
Change in White spot lesions dimension
Time Frame: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Quantified using computer-assisted analysis based on digital intraoral photographs
Secondary Outcomes
- change in lesion fluorescence(6 months: (Baseline, 1 week, 1 month, 3 months, 6 months))
Study Sites (1)
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