Bioactive Glass in the Treatment of Enamel White Spot Lesions
Primary Purpose
White Spot Lesion of Tooth
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
BiominF
Novamin
CPP-ACP
Sponsored by
About this trial
This is an interventional treatment trial for White Spot Lesion of Tooth focused on measuring Bioactive glass, CPP-ACP, Remineralization, White spot lesions
Eligibility Criteria
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.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
BiominF®
Novamin®
CPP-ACP
Arm Description
Test group
Test group
Control group
Outcomes
Primary Outcome Measures
Change in White spot lesions dimension
Quantified using computer-assisted analysis based on digital intraoral photographs
Secondary Outcome Measures
change in lesion fluorescence
evaluated using diode laser fluorescence device (Diagnodent)
Full Information
NCT ID
NCT04401280
First Posted
May 15, 2020
Last Updated
October 11, 2021
Sponsor
Rania Salah
Collaborators
Queen Mary University of London
1. Study Identification
Unique Protocol Identification Number
NCT04401280
Brief Title
Bioactive Glass in the Treatment of Enamel White Spot Lesions
Official Title
Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rania Salah
Collaborators
Queen Mary University of London
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion of Tooth
Keywords
Bioactive glass, CPP-ACP, Remineralization, White spot lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BiominF®
Arm Type
Active Comparator
Arm Description
Test group
Arm Title
Novamin®
Arm Type
Active Comparator
Arm Description
Test group
Arm Title
CPP-ACP
Arm Type
Active Comparator
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
BiominF
Intervention Description
in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
Intervention Type
Drug
Intervention Name(s)
Novamin
Intervention Description
in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
Intervention Type
Drug
Intervention Name(s)
CPP-ACP
Intervention Description
applied in accordance with the manufacturer's specifications
Primary Outcome Measure Information:
Title
Change in White spot lesions dimension
Description
Quantified using computer-assisted analysis based on digital intraoral photographs
Time Frame
6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Secondary Outcome Measure Information:
Title
change in lesion fluorescence
Description
evaluated using diode laser fluorescence device (Diagnodent)
Time Frame
6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Bioactive Glass in the Treatment of Enamel White Spot Lesions
We'll reach out to this number within 24 hrs