Clinical trial NCT04908293: Home Remineralization of White Spot Lesions With Two Different Toothpastes.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Keywords: remineralization
hydroxyapatite
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
timeFrame: Study begin, 15, 30 and 90 days.
measure: Change in Schiff Air Index - Dental sensitivity test
timeFrame: Study begin, 15, 30 and 90 days.
measure: Change in VAS score
timeFrame: Study begin, 15, 30 and 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butera A, Gallo S, Pascadopoli M, Montasser MA, Abd El Latief MH, Modica GG, Scribante A. Home Oral Care with Biomimetic Hydroxyapatite vs. Conventional Fluoridated Toothpaste for the Remineralization and Desensitizing of White Spot Lesions: Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Jul 16;19(14):8676. doi: 10.3390/ijerph19148676.