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Home Remineralization of White Spot Lesions With Two Different Toothpastes.

U

University of Pavia

Status

Completed

Conditions

White Spot Lesion

Treatments

Other: Colgate toothpaste
Other: Biorepair toothpaste

Study type

Interventional

Funder types

Other

Identifiers

NCT04908293
2021-WHITESPOTS

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

Trial Group
Experimental group
Description:
Use of New Biorepair Advanced Sensitive toothpaste for home oral care.
Treatment:
Other: Biorepair toothpaste
Control Group
Active Comparator group
Description:
Use of Colgate toothpaste for home oral care.
Treatment:
Other: Colgate toothpaste

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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