Home Remineralization of White Spot Lesions With Two Different Toothpastes.

Not Applicable

Completed

• Conditions: White Spot Lesion
• Interventions: Other: Colgate toothpaste; Other: Biorepair toothpaste

• Registration Number: NCT04908293
• Lead Sponsor: University of Pavia

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-23
• Study Start: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-01
• Status Verified: 2021-10
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-20
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Colgate toothpaste	Use of Colgate toothpaste for home oral care.
Trial Group	Biorepair toothpaste	Use of New Biorepair Advanced Sensitive toothpaste for home oral care.

Primary Outcome Measures

Name	Time	Method
Change in VAS score	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.
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)	Study begin, 15, 30 and 90 days.	Scoring criteria: 0: no erosive tooth wear; 1. initial loss of surface texture; 2. distinct defect, hard tissue loss \< 50% of the surface area; 3. hard tissue loss ≥ 50% of the surface area.
Change in Schiff Air Index - Dental sensitivity test	Study begin, 15, 30 and 90 days.	Scoring criteria: 0: the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy