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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
Rania Salah
About
Eligibility
Locations
Arms
Outcomes
Full info

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

14 Years - 26 Years (Child, Adult)All SexesAccepts 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.

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

First Posted
May 15, 2020
Last Updated
October 11, 2021
Sponsor
Rania Salah
Collaborators
Queen Mary University of London
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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

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