Bioactive Glass in the Treatment of Enamel White Spot Lesions

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04401280

Enrollment

Registered

2020-05-26

Start date

2020-06-01

Completion date

2021-06-30

Last updated

2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion of Tooth

Keywords

Bioactive glass, CPP-ACP, Remineralization, White spot lesions

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

Interventions

DRUGBiominF

in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached

DRUGNovamin

in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached

DRUGCPP-ACP

applied in accordance with the manufacturer's specifications

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

14 Years to 26 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in White spot lesions dimension	6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)	Quantified using computer-assisted analysis based on digital intraoral photographs

Secondary

Measure	Time frame	Description
change in lesion fluorescence	6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)	evaluated using diode laser fluorescence device (Diagnodent)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026