Bioactive Glass in the Treatment of Enamel White Spot Lesions

Phase 3

Completed

• Conditions: White Spot Lesion of Tooth
• Interventions: Drug: BiominF; Drug: Novamin; Drug: CPP-ACP

• Registration Number: NCT04401280
• Lead Sponsor: Rania Salah

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Study Start: 2020-06-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BiominF®	BiominF	Test group
Novamin®	Novamin	Test group
CPP-ACP	CPP-ACP	Control group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Egypt