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

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

Study Overview

• Status: Completed
• Conditions: White Spot Lesion of Tooth
• Intervention / Treatment: Drug: BiominF; Drug: Novamin; Drug: CPP-ACP

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BiominF®; Test group	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
Active Comparator: Novamin®; Test group	Drug: Novamin; in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
Active Comparator: CPP-ACP; Control group	Drug: CPP-ACP; applied in accordance with the manufacturer's specifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rania Salah
• Collaborators: Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Remineralization; Bioactive glass; White spot lesions; CPP-ACP
• Additional Relevant MeSH Terms: Skin Diseases; Exanthema
• Other Study ID Numbers: WSL treatment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No