Bioactive Glass in the Treatment of Enamel White Spot Lesions

NCT04401280 — Phase 3, Completed, 60 participants, Rania Salah

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

Registry	NCT04401280
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Actual)
Sponsor	Rania Salah (Other); collaborators: Queen Mary University of London
Conditions	White Spot Lesion of Tooth
Interventions	BiominF, Novamin, CPP-ACP (Drug)
Dates	start 2020-06-01, primary completion 2021-06-30, completion 2021-06-30, first posted 2020-05-26, last updated 2021-10-19
Locations	1 site in Egypt

-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

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+Arms and interventions

Arm	Type	Interventions	Description
BiominF®	Active comparator	Drug: BiominF	Test group
Novamin®	Active comparator	Drug: Novamin	Test group
CPP-ACP	Active comparator	Drug: CPP-ACP	Control group

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

+Outcome measures

Primary outcomes

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 outcomes

change in lesion fluorescence [6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)]: evaluated using diode laser fluorescence device (Diagnodent)

+Eligibility

Sex: All, ages: 14 Years to 26 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry	Alexandria	Egypt