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

University of Pavia

Status: Completed

Conditions: Black Stains

Treatments: Other: Standard home oral care; Other: Probiotics products; Other: Lactoferrin products

Study type: Interventional

Funder types: Other

Identifiers

NCT04865796

2021-BLACKSTAINS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with black stains
• Patients with high compliance

Exclusion criteria

• Patients suffering from psychological, neurological or psychiatric disorders
• Pregnant or breastfeeding women
• Patients undergoing anti-cancer therapy
• Patients with low compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

Group 1

Experimental group

Description:

Patients will use products based on lactoferrin.

Treatment:

Other: Lactoferrin products

Probiotics

Experimental group

Description:

Patients will use products based on probiotics for home oral care.

Treatment:

Other: Probiotics products

Standard therapy

Active Comparator group

Description:

Patients will use standard toothpastes for home oral care.

Treatment:

Other: Standard home oral care