Black Stains
Conditions
Keywords
Oral microbiota, Periodontal bacteria
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.
Interventions
OTHERLactoferrin products
Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.
OTHERProbiotics products
Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.
OTHERStandard home oral care
Patiens will use a normal toothpaste for home oral care.
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the extension of black stains (Gasparetto et al., 2003) | Study begin, 2 and 6 months. | Scoring criteria: * 1: presence of pigmented dots or thin lines with incomplete coalescence parallel to gingival margin; * 2: continuous pigmented lines, which can be easily observed and limited to half of the cervical third of the tooth surface; * 3: presence of pigmented stains extending beyond half of the cervical third of the tooth surface |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in DMFT (Decayed Missing Filled Teeth) score | Study begin, 2 and 6 months. | It's the measure of caries experience worldwide. This index gives the sum of an individual's decayed, missing, and filled permanent teeth. It ranges from 0 to 32 (including the wisdom teeth). The higher the score, the worst the oral health condition of the patient. |
| Change in DMFS (Decayed Missing Filled Surfaces) score | Study begin, 2 and 6 months. | It's the measure of caries experience worldwide. This index gives the sum of an individual's decayed, missing, and filled permanent surfaces. It ranges from 0 to 148 (including the wisdom teeth). The higher the score, the worst the oral health condition of the patient. |
| Dietary habits | Study begin, 2 and 6 months. | Patients will ask to assess if there is a consumption of the following foods and drinks ≤ 3 times /months, ≤ 6/week, ≥ 1/day: Beet Swiss chard Broccoli Candies Meat Cabbage Desserts Fresh fruit Dairy product Legumes Spinach Eggs Vegetable Coffee Coca Cola Natural juices Red juices The Red wine |
Countries
Italy
Outcome results
None listed