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CompletedNCT04401280Updated Oct 19, 2021

Bioactive Glass in the Treatment of Enamel White Spot Lesions

A Phase 3 interventional study of BiominF and Novamin in White Spot Lesion of Tooth, sponsored by Rania Salah. Completed at 1 site in Egypt. Open to participants aged 14 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-19.

Sponsored by Rania Salah · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
14 Years to 26 Years
Sex
All
01

Study 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

02

Conditions studied

  • White Spot Lesion of Tooth

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Keywords

  • Bioactive glass
  • CPP-ACP
  • Remineralization
  • White spot lesions
03

Who can participate

Ages eligible
14 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    BiominF®

    Test group

    Drug: BiominF

  • Active comparator
    Novamin®

    Test group

    Drug: Novamin

  • Active comparator
    CPP-ACP

    Control group

    Drug: CPP-ACP

Interventions

  • DrugBiominF

    in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached

  • DrugNovamin

    in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached

  • DrugCPP-ACP

    applied in accordance with the manufacturer's specifications

05

What researchers measure

Primary outcomes

  1. Change in White spot lesions dimension

    Quantified using computer-assisted analysis based on digital intraoral photographs

    Time frame: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)

Secondary outcomes

  1. change in lesion fluorescence

    evaluated using diode laser fluorescence device (Diagnodent)

    Time frame: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)

06

Study locations

1 site
  • Faculty of Dentistry
    Alexandria, Egypt
07

Registry details

Key details

Study ID
NCT04401280
Lead sponsor
Rania Salah
Collaborators
Queen Mary University of London
Responsible party
Rania Salah (Clinical instructor and Principal investigator at conservative dentistry department, Alexandria University) — Sponsor-investigator
First posted
May 26, 2020
Start date
Jun 1, 2020
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021
Last update
Oct 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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