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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Black Stains

Intervention / Treatment
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* Other: Lactoferrin products
* Other: Probiotics products
* Other: Standard home oral care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Patients will use products based on lactoferrin. | Other: Lactoferrin products<br>* Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.<br>|
| Experimental: Probiotics<br>Patients will use products based on probiotics for home oral care. | Other: Probiotics products<br>* Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.<br>|
| Active Comparator: Standard therapy<br>Patients will use standard toothpastes for home oral care. | Other: Standard home oral care<br>* Patiens will use a normal toothpaste for home oral care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the extension of black stains (Gasparetto et al., 2003) | 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 | Study begin, 2 and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DMFT (Decayed Missing Filled Teeth) score | 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. | Study begin, 2 and 6 months. | 
| Change in DMFS (Decayed Missing Filled Surfaces) score | 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. | Study begin, 2 and 6 months. | 
| Dietary habits | 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 | Study begin, 2 and 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral microbiota, Periodontal bacteria