Home Remineralization of White Spot Lesions With Two Different Toothpastes.

NCT04908293 | Completed

• 1 other identifier: 2021-WHITESPOTS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesion

Keywords

remineralization; hydroxyapatite

Outcome Measures

Primary Outcomes (3)

• Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)

  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.

  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; 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.

  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.

Study Arms (2)

Trial Group

EXPERIMENTAL

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

Other: Biorepair toothpaste

Control Group

ACTIVE COMPARATOR

Use of Colgate toothpaste for home oral care.

Other: Colgate toothpaste

Interventions

Biorepair toothpaste OTHER

Use of New Biorepair Advanced Sensitive for home oral care.

Trial Group

Colgate toothpaste OTHER

Use of Colgate toothpaste for home oral care.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with white spot lesions;
• patients with dental sensibility;
• adult patients;
• patients that sign the informed consent to participate to the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Related Publications (1)

• 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.

  PMID: 35886524 DERIVED

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 1, 2021
• Study Start: May 28, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 20, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)