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

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

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.

Study Overview

• Status: Completed
• Conditions: Black Stains
• Intervention / Treatment: Other: Lactoferrin products; Other: Probiotics products; Other: Standard home oral care

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): January 16, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Oral microbiota; Periodontal bacteria
• Additional Relevant MeSH Terms: Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: 2021-BLACKSTAINS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be available upon motivated request to Principal Investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No