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Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial.

NCT04865796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-01-31

No results posted yet for this study

Summary

The aim of this study is to investigate epidemiology and treatment possibilities of black stains, with the assessment of a possible correlation with patients' dietary habits.

Patients will be randomly divided into three groups. For each group, clinical evaluation will be performed at the study begin, after 2 and after 6 months.

At the study begin, evaluation of black stains with Gasparetto's classification will be assessed; then professional oral hygiene with ultrasonic scaler will be performed, plus glycine and polish; then, products for home oral care will be given to patients, depending on the groups. The clinical situation will be re-evaluated after 2 and after 6 months. Home oral care will be performed with different products, containing lactoferrin (group 1) and probiotics (group 2). The control group (Group 3) will use normal products.

Conditions

  • Black Stains

Interventions

OTHER

Lactoferrin products

Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.

OTHER

Probiotics products

Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.

OTHER

Standard home oral care

Patiens will use a normal toothpaste for home oral care.

Sponsors & Collaborators

  • University of Pavia

    lead OTHER

Principal Investigators

  • Andrea Scribante, DDS, PhD. · University of Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2022-01-13
Completion
2022-01-16

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865796 on ClinicalTrials.gov