Home Remineralization of White Spot Lesions With Two Different Toothpastes.

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.

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.

Study Overview

• Status: Completed
• Conditions: White Spot Lesion
• Intervention / Treatment: Other: Biorepair toothpaste; Other: Colgate toothpaste

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial Group; Use of New Biorepair Advanced Sensitive toothpaste for home oral care.	Other: Biorepair toothpaste; Use of New Biorepair Advanced Sensitive for home oral care.
Active Comparator: Control Group; Use of Colgate toothpaste for home oral care.	Other: Colgate toothpaste; Use of Colgate toothpaste for home oral care.

What is the study measuring?

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 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.

Collaborators and Investigators

• Sponsor: University of Pavia

Publications and helpful links

General Publications

• 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). pii: 8676. doi: 10.3390/ijerph19148676.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: May 23, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: remineralization; hydroxyapatite
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: 2021-WHITESPOTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be available upon motivated request to Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No