Home Remineralization of White Spot Lesions With Two Different Toothpastes.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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White Spot Lesion

Intervention / Treatment
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* Other: Biorepair toothpaste
* Other: Colgate toothpaste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Group<br>Use of New Biorepair Advanced Sensitive toothpaste for home oral care. | Other: Biorepair toothpaste<br>* Use of New Biorepair Advanced Sensitive for home oral care.<br>|
| Active Comparator: Control Group<br>Use of Colgate toothpaste for home oral care. | Other: Colgate toothpaste<br>* Use of Colgate toothpaste for home oral care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 alland 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remineralization, hydroxyapatite