NCT04865796

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 as follows: * Group 1: patients will use 2 Forhans GengiFor tables (between foods) and Forhans Scudo Naturale toothpaste containing lactoferrin. * Group 2: patients will use Biorepair Peribioma chewing-gum for 10 minutes/day and Biorepair Peribioma toothpaste containing probiotics. * Group 3: patients will choose the best product for their home oral care.

Conditions

• Black Stains

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-15
• Primary completion: 2022-01-13
• Completion: 2022-01-16
• First posted: 2021-04-29
• Last updated: 2022-01-31

Locations

1 site across 1 country: Italy