Clinical trial NCT04865796: Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial.
Official title: Epidemiology, Clinical Evaluation of Black Stains and Patients' Dietary Habits: a Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Black Stains
Keywords: Oral microbiota
Periodontal bacteria
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the extension of black stains (Gasparetto et al., 2003)
timeFrame: Study begin, 2 and 6 months.
Secondary outcomes:
measure: Change in DMFT (Decayed Missing Filled Teeth) score
timeFrame: Study begin, 2 and 6 months.
measure: Change in DMFS (Decayed Missing Filled Surfaces) score
timeFrame: Study begin, 2 and 6 months.
measure: Dietary habits
timeFrame: Study begin, 2 and 6 months.
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD.
role: PRINCIPAL_INVESTIGATOR
References: