Home Remineralization of White Spot Lesions With Two Different Toothpastes.

White Spot Lesion Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908293
• Other study ID #: 2021-WHITESPOTS
• Status: Completed
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: October 20, 2021

Study information

• Verified date: October 2021
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 20, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• White Spot Lesion

Intervention

Other:
• Biorepair toothpaste
Use of New Biorepair Advanced Sensitive for home oral care.
• Colgate toothpaste
Use of Colgate toothpaste for home oral care.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)	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.	Study begin, 15, 30 and 90 days.
Primary	Change in Schiff Air Index - Dental sensitivity test	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.	Study begin, 15, 30 and 90 days.
Primary	Change in VAS score	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.	Study begin, 15, 30 and 90 days.