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Home Remineralization of White Spot Lesions With Two Different Toothpastes.

NCT ID: NCT04908293

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2021-10-20

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.

Conditions

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White Spot Lesion

Keywords

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remineralization hydroxyapatite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trial Group

Use of New Biorepair Advanced Sensitive toothpaste for home oral care.

Group Type EXPERIMENTAL

Biorepair toothpaste

Intervention Type OTHER

Use of New Biorepair Advanced Sensitive for home oral care.

Control Group

Use of Colgate toothpaste for home oral care.

Group Type ACTIVE_COMPARATOR

Colgate toothpaste

Intervention Type OTHER

Use of Colgate toothpaste for home oral care.

Interventions

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Biorepair toothpaste

Use of New Biorepair Advanced Sensitive for home oral care.

Intervention Type OTHER

Colgate toothpaste

Use of Colgate toothpaste for home oral care.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 35886524 (View on PubMed)

Other Identifiers

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2021-WHITESPOTS

Identifier Type: -

Identifier Source: org_study_id