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Completed

NCT Number: NCT04908293

Home Remineralization of White Spot Lesions With Two Different Toothpastes.

The aim of the study is to compare white spot lesions before, during and after treatment with New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite and Colgate toothpaste with 1450 ppm of fluoride. The timeline will consider the study begin, 15 days, 30 days and 90 days after the beginning of the study. The following indices will be recorded: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.

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Key information

Conditions

White Spot Lesion

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

About this study

The aim of the study is to compare white spot lesions before, during and after treatment with two different toothpastes for home oral care. Patients who agree to sign the informed consent will be randomly assigned to two different groups:

  • Trial Group will use New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite;
  • Control Group will use Colgate toothpaste with 1450 ppm of fluoride.

At the baseline, professional oral hygiene will be performed. The following indices will be recorded at the study begin and at the following 15, 30 and 90 days: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with white spot lesions;
  • patients with dental sensibility;
  • adult patients;
  • patients that sign the informed consent to participate to the study.

Exclusion criteria

  • patients with low compliance or motivation to participate to the study;
  • patients not presenting white spot lesions;
  • patients with absence of dental sensibility;
  • patients pregnant or breastfeeding;
  • underage patients;
  • patients with psychiatric diseases.

Treatment and study plan

Biorepair Toothpaste

Other

Use of New Biorepair Advanced Sensitive for home oral care.

Colgate toothpaste

Other

Use of Colgate toothpaste for home oral care.

Primary outcomes

  1. Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)

    Time frame: Study begin, 15, 30 and 90 days.

    Scoring criteria:

    0: no erosive tooth wear;

    • initial loss of surface texture;
    • distinct defect, hard tissue loss < 50% of the surface area;
    • hard tissue loss ≥ 50% of the surface area.

  2. Change in Schiff Air Index - Dental sensitivity test

    Time frame: Study begin, 15, 30 and 90 days.

    Scoring criteria:

    0: the subject did not respond to air blasting;

    • the subject responded to air blasting;
    • the subject responded to air blasting and requested discontinuation;
    • the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.

  3. Change in VAS score

    Time frame: Study begin, 15, 30 and 90 days.

    Evaluation of the evoked pain with air blasting from 0 to 10. The VAS scale is a straight line with the endpoints defining extreme limits with "no pain at all"and "pain as bad as it could be"; they correspond respectively to 0 and 10. The patient indicates the score of the perceived pain from 0 to 10.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

A Comparison Between a Toothpaste With Micro Crystals of Hydroxyapatite and a Toothpaste With 1450 Ppm of Fluoride in the Home Remineralization of White Spot Lesions: a Clinical Trial.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2021
Registry last updated
Oct 28, 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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