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Bioactive Glass in the Treatment of Enamel White Spot Lesions

NCT ID: NCT04401280

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-06-30

Brief Summary

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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

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Conditions

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White Spot Lesion of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BiominF®

Test group

Group Type ACTIVE_COMPARATOR

BiominF

Intervention Type 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®

Test group

Group Type ACTIVE_COMPARATOR

Novamin

Intervention Type 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

Control group

Group Type ACTIVE_COMPARATOR

CPP-ACP

Intervention Type DRUG

applied in accordance with the manufacturer's specifications

Interventions

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BiominF

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

Novamin

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

CPP-ACP

applied in accordance with the manufacturer's specifications

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role collaborator

Rania Salah

OTHER

Sponsor Role lead

Responsible Party

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Rania Salah

Clinical instructor and Principal investigator at conservative dentistry department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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WSL treatment

Identifier Type: -

Identifier Source: org_study_id