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Completed

NCT Number: NCT04401280

Bioactive Glass in the Treatment of Enamel White Spot Lesions

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

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Key information

Conditions

White Spot Lesion of Tooth

Age range

14 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BiominF

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

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

Drug

applied in accordance with the manufacturer's specifications

Primary outcomes

  1. Change in White spot lesions dimension

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

    Quantified using computer-assisted analysis based on digital intraoral photographs

Secondary outcomes

  1. change in lesion fluorescence

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

    evaluated using diode laser fluorescence device (Diagnodent)

Sponsors and collaborators

Lead sponsor

Rania Salah

Other

Collaborators

  • Queen Mary University of London

Registry information

Official study title

Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 26, 2020
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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