Bioactive Glass in the Treatment of Enamel White Spot Lesions

White Spot Lesion of Tooth Clinical Trial

Official title:

Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401280
• Other study ID #: WSL treatment
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Exanthema
• White Spot Lesion of Tooth

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)